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Venkatakrishna Shyamala, Ph. D.
Molecular Diagnostics and Blood Testing (>25 years Biotech experience)
E-mail: vshyamala@netscape.net ; Web Contact: http://www.linkedin.com/in/vshyamala
Country of Citizenship: United States of America

RESEARCH AND WORK EXPERIENCE
Independent Consultant
10/2008       Consultant, Molecular in vitro Diagnostics, Blood Screening and Molecular Biology
To Present     Consultant – Novartis Vaccines and Diagnostics, Scientific Affairs; Achira Labs Inc., India;
                    Reuters Insight Expert, Zintro Expert
               CLSI Area committee for Molecular Methods-Observer; subcommittee participant for “Point-of-
                    Care Testing for Infectious Diseases”, “Nucleic Acid Sequencing Methods in Diagnostic
                    Laboratory Medicine” and “Microarrays for diagnosis and Monitoring of Infectious Diseases”.
               CLSI publications: MM01 (2012)- Molecular Methods for Clinical Genetics and Oncology
                    testing 3rd Ed.; MM19 (2011) Establishing Molecular Testing in Clinical Laboratory
                    Environments; MM09 (2010) Quantitative Molecular Methods for Infectious Diseases 2nd Ed.
At Innovative Biosensors, Inc., Rockville, Maryland
7/2007 To     Senior Vice President, Research and Development; Clinical Diagnostics on CANARY TM platform,
10/2008       Next generation technologies
               2 provisional patent applications
               Leading a team of 10 scientists tasked to facilitate developing and launching Diagnostics assays
                    for MRSA, Chlamydia trachomatis and Group B Streptococcus; Feasibility evaluation of Next
                    Generation technologies.
               Initiated Pilot Clinical trial studies at Indiana University and UM Shock Trauma Center for the
                    CANARYTM-MRSA assay and CANARYTM-Chlamydia assays.
               3 year NSF-MASINT grant to develop Hand-held Biosensors in collaboration with the
                    Engineering department at Univ of Maryland at College Park.
At Digene Corporation, Gaithersburg, Maryland
3/2006 To     Director; Assay Development, Next Generation Platform Technologies for Nucleic Acid Detections
7/2007        of HPV, CT and NG
              5 Invention Disclosures
               Leading a team of 14 scientists tasked to facilitate development of Next Generation assay for
                    Chlamydia trachomatis and Neisseria gonorrhoea.
               Completed Analytical Sensitivity comparison of commercially available nucleic acid detection
                    assays including Roche, GenProbe, and Abbott for 16 serovars of CT with Digene Hybrid
                    CaptureR, Digene Isothermal and Digene Helicase Dependent Amplification assays.
Chiron Corporation 1990-2006
At Chiron Corporation-Blood Testing Division, Emeryville, California
6/2004 To     Associate Director; Research Leader of the Next Generation Platform Technologies for Nucleic Acid
3/2006        Detections of HBV, HCV, WNV, Parvo B19 and HAV for Blood Screening.
              5 publications, 9 presentations at Scientific conferences.
               Leading a team of 3 scientists and several research associates to quickly evaluate and identify the
                  best amongst 10 Nucleic acid isolation technologies in the newly assigned project.
              Established collaborations with 8 companies and tested in-house, novel amplification-detection
                  technologies.
              Have been a liaison as assay development expert to other departments, affiliates and customers in
                  the existing and new product related questions.
              year NSF grant to develop a diagnostic assay for the detection of Hanta Virus in collaboration
                  with Univ of Arizona.
4/2000 To     Senior Scientist-Associate Director; Research Leader and Project Team Leader of the PCR based
6/2004        Alternative NAT assays for HBV, HCV and WNV for Blood Screening.
               5 publications, 4 patents, 27 presentations at Scientific conferences.
               Led and managed assay development teams for HBV, HCV and WNV Tests; research and
                  development activities, including optimizations of assay reagents and test system, and transfer of
                  product to Reference Testing Laboratories.



V. Shyamala                                         1                                            7/26/2012
 Worked in liaison with Validation, Statistics, Marketing/Business Development, Regulatory-
                  Clinical affairs & Scientific affairs to design and execute Market evaluations, Registration studies.
                Identified, negotiated and placed the Confirmatory Alternative assays for HBV and WNV in the
                  GMP qualified Bayer Reference and Testing Laboratories (BRTL), and the HCV assay at Blood
                  Systems Research Institute (BSRI).
                Played a key role in IND and BLA submissions of Procleix-Duplex (HCV) and Procleix-Ultrio
                  (HBV) in confirming the Clinical trial positives. Key role in IND submission of Procleix-WNV
                  assay. Helped the Regulatory Affairs to review the Clinical report for Procleix-Ultrio for CE Mark
                  and FDA submission and approval.
                Participated in several Coded studies offered by US and Canadian Blood banks, CBER (USA),
                  QCMD (UK), ISS & EQA (Italy) and VQC (Netherlands) for HCV, HBV and WNV Qualitative
                  and Quantitative assays. Publication and presentation of these data, resulting in numerous
                  collaborations.
                Interfaced with Chiron Legal department to research on competitor marketed HIV and HCV assay
                  reagents.

At Chiron Corporation -Technologies Division, Emeryville, CA
1/1996 To    Principal Scientist, Coordinated the efforts of scientists from various disciplines including
10/2000      chemistry, high-through put screening and phage display to examine the effect of ligand
             dimerization on receptor activation. Generated cell lines overexpressing recombinant and chimeric
             receptor. Set up ligand binding and signaling assays for high through-put screening. Identified
             novel orphan receptors, and determined their expression profile.

6/1994 To      Research Scientist. Analyzed signaling by tumor necrosis factor receptors I and II. Identified
1/1996         kinase interacting proteins by the yeast two hybrid system.
               Identified novel, alternatively spliced endothelin B receptor. Defined features of IL-8 to interact and
               signal with IL-8 receptors 1 and 2. Defined signaling molecules for IL-8 receptors.
               Identified and isolated several novel orphan seven transmembrane receptors.

6/1990 To      Research Biochemist, Identified conserved sequences in the 5’ and 3’ region of Hepatitis C viral
6/1994         RNA. Developed an internal standard RNA for RT-PCR based quantitation of hepatitis C viral
               RNA in tissue samples. Examined the translational control by the untranslated 5’ end of HCV RNA.

Post-Doctoral Experience
1986-1990     Visiting Scientist Department of Biochemistry, University of California at Berkeley, CA.
              Developed PCR based methods for gene analysis. Studied structure-function relationship of the
              bacterial histidine permease and recombination events.
1984-1986     Scientist. Pacific Presbyterian Hospital, San Francisco, CA.
1983-1984     Post Doctoral Fellow (with Dr. J. Inselburg). Dartmouth College, Hanover, NH.
1979-1983     Post Doctoral Fellow (with Dr. H. W. Dickerman) NY State Department of Health Albany, NY.

EDUCATION
1973-1979 Ph.D., Department of Biochemistry, Indian Institute of Science, Bangalore, India.
          Thesis: Effect of starvation on rat liver organelles.

AREAS OF EXPERTISE
Background Ph.D. in Biochemistry and Molecular Biology

Assay         Evaluated Nucleic Acid Testing (NAT) technologies, extensive virology and bacteriology experience,
Development Primer/probe designs and NAT assay development; Strong troubleshooting skills and innovative
and Technical thinking; Novel NAT detection methods, cDNA library screening, molecular cloning, sequencing and
              expression.

Scientific     Developed and maintained contacts with key external opinion leaders, clinical investigators, and
Affairs        other key customers in blood screening and diagnostic field; Marketing study designs; Authored
               several original publications; Presented scientific data at numerous professional conferences; Solid


V. Shyamala                                          2                                             7/26/2012
knowledge and experience on assay development and product improvements; Critical data analysis
               and interpretation. Recruited subject experts to IBI Scientific Advisory Board, monthly progress
               presentations to Board members, procured NSF-MASINT and NIH grant.

Other Areas    Reviewed Clinical trial data for IND and BLA preparation and submission; B round financing of $12
               million for IBI; IRB procurement to initiate pilot MRSA clinical studies

EXTRA MURAL FUNDING
2008-2010 3 year NSF-MASINT grant to develop Hand-held Biosensors in collaboration with the Engineering
          department at Univ of Maryland at College Park.
2003-2007 year NSF grant to develop a diagnostic assay for the detection of Hanta Virus in collaboration
          with Univ of Arizona.
2007-2008 Invited reviewer by NSF for the Ohio State interdisciplinary grant.



SELECTED PUBLICATIONS

Patents        Patents:
Issued/Filed   1.   C. Cote, Q.-X. Zheng, V. Shyamala, T. Hazel: Methods and Systems for Detecting Methicillin-
                    Resistant Staphylococcus (2008) PCT/US09/43143
               2.   V. Shyamala, S. Pichuantes and S. Nguyen: Methods and Reagents for Detecting Hantavirus
                    (2005) WO 2008/008444 A2
               3.   V. Shyamala: Identification of oligonucleotides for the capture, detection and quantitation of
                    Hepatitis A viral RNA (2003) WO2003/106641.
               4.   V. Shyamala: Identification of oligonucleotides for the capture, detection and quantitation of
                    West Nile viral RNA (2002) WO2004/055159 A2; US 7,132,233 B2.
               5.   S. Pichuantes, and V. Shyamala: Diagnostic assays for Parvovirus B19 (2002) WO 03/002753
                    A2; US 6,936,442 (2005).

Original       1. R. Emmadi, J.B. Boonyaratanakornkit, R. Selvarangan, V. Shyamala, B. L. Zimmer, L.
Papers            Williams, B. Bryant, T. Schutzbank, M. M. Schoonmaker, J. A. Amos Wilson, L. Hall, P.
Since 1989        Pancholi and K. Bernard (2011) Molecular methods and platforms for infectious diseases
                  testing. A review of FDA approved and cleared assays. J. Mol. Diagnostics 13, 583-604.
               2. S. Kleinman, S. Glynn, T.-H. Lee, L. Tobler, L. Montalvo, D. Todd, J. Kiss, V. Shyamala, M.
                  Busch (2007) Prevalence and quantitation of Parvovirus B19 DNA levels in blood donors using
                  a sensitive PCR screening assay. Transfusion 47, 1756-1764.
               3. M. Busch , S. Caglioti, G. Robertson, J. McAuley, L. Tobler , H. Kamel, J. Linnen, V.
                  Shyamala, P. Tomasulo, and S. Kleinman (2005) Screening the blood supply for West Nile
                  Virus RNA by nucleic acid amplification testing. New Engl. J. Med. 353, 460-467.
               4. M. P. Busch, L.H. Tobler, J. Saldanha, S. Caglioti, V. Shyamala, J. Linnen, J. Gallarda, B.
                  Phelps, R. Smith, and S. H. Kleinman (2005) Analytical and Clinical Sensitivity of First
                  Generation West Nile Virus RNA Screening and Confirmatory Assays. Transfusion 45, 492-
                  499.
               5. A. Cox, D. M. Netski, T. Mosburger, S.G. Sherman, S. Strathdee, D. Ompad, D. Vlahov, V.
                  Shyamala, D. Chien, S. C. Ray and D. Thomas (2005) Prospective evaluation of community-
                  acquired acute hepatitis C. Clin. Infect. Dis. 40, 951-958.
               6. L. H. Tobler, C. Bianco, S. A. Glynn, G. B. Schreiber, B. J. Dille, H. E. Prince, R. S. Lanciotti,
                  J. M. Linnen, J. Galarda, V. Shyamala, D. Smith, S. H. Kleinman and M. P. Busch (2005)
                  Detection of West Nile Virus (WNV) RNA and antibody in frozen plasma components recalled
                  from the 2002 peak epidemic. Transfusion 45, 480-486.
               7. V. Shyamala, P. Arcangel, J. Cottrell, D. Coit, A. Medina-Selby, C. McCoin, D. Madriaga, D.
                  Chien and B. Phelps (2004) Assessment of the Target-Capture PCR Hepatitis B Virus (HBV)
                  DNA Quantitative Assay and Comparison with Commercial HBV DNA Quantitative Assays. J.
                  Clin. Microbiol. 42, 5199-5204.



V. Shyamala                                         3                                             7/26/2012
8.    G. Pisani, K. Cristiano, J. Saldanha, M. Wirz, G. M. Bisso, C. Mele, G. Gentili and the EQA
                    Participants. (2004) External quality assessment for the detection of blood-borne viruses in
                    plasma by nucleic acid amplification technology: the first human immunodeficiency virus and
                    hepatitis B virus studies (HIV EQA/1 and HBV EQA/1) and the fifth hepatitis C virus study
                    (HCV EQA/5). Vox Sanguinis 87, 91-95.
              9.    V. Shyamala, J. Cottrell, P. Arcangel, D. Madriaga, J. Linnen, B. Phelps, and D. Chien (2004)
                    Detection and quantitation of HBV DNA in the WHO International standard for HIV-1 RNA. J.
                    Virol. Meth. 118, 69-72.
              10.   C. Gentili, G. Pisani, J. Saldhana, K. Cristiano, Wirz, G. M. Bisso, C. Mele, and the EQA
                    participants. (2003) High proficiency in detecting the six major hepatitis C virus genotypes of
                    laboratories involved in testing plasma by nucleic acid amplification technology. Vox
                    Sanguinis 85, 114-116.
              11.   J.-P. Allain, D. Candotti, K. Soldan, F. Sarkodie, B. Phelps, C. Giachetti, V. Shyamala, F.
                    Yeboah, M. Anokwa, S. Owusu-Ofori, and O. Opare-Sem (2003) The risk of hepatitis B virus
                    infection by transfusion in Kumasi, Ghana. Blood 101, 2419-2425.
              12.   H. Khoja, G. Wang, C.-T. Lee Ng, J. Tucker, T. Brown, and V. Shyamala (2000) Cloning of
                    CCRL1, an orphan seven transmembrane receptor related to chemokine receptors, expressed
                    abundantly in the heart. Gene 246, 229-238.
              13.    M.D. Ballinger, V. Shyamala, L. D. Forrest, M. Deuter-Reinhard, L.V. Doyle, J. X. Wang, L.
                    Panganiban-Lustan, J. R. Stratton JR, G. Apell, J. A. Winter, M. V. Doyle, S. Rosenberg, W.M.
                    Kavanaugh (1999). Semirational design of a potent, artificial agonist of fibroblast growth factor
                    receptors. Nat. Biotechnol. 17, 1199-1204.
              14.   V. Shyamala, H. Khoja, M. L. Anderson, J.-X. Wang, H. Cen, and W. M. Kavanaugh (1999)
                    High-throughput screening for ligand-induced c-fos mRNA expression by branched DNA assay
                    in chinese hamster ovary cells. Anal. Biochem. 266, 140-147.
              15.   V. Shyamala, and H. Khoja (1998) Interleukin-8 receptors R1 and R2 activate mitogen-
                    activated protein kinases and induce c-fos, independent of Ras and Raf-1 in chinese hamster
                    ovary cells. Biochemistry 37, 15918-15924.
              16.   V. Shyamala, H. Khoja, and M. Moghadam (1998) Inhibition of adenylyl cyclase by 
                    chemokines IL-8 and GRO- in chinese hamster ovary cells expressing R1 and R2 receptors. J.
                    Interferon Cytokine Res. 18, 235-239.
              17.   C. Caudai, M. G. Padula, I. Bastianoni, P. E. Valensin, V. Shyamala, J. Han, C. A. Boggiano,
                    P. Almi (1998) Antibody testing and RT-PCR in hepatitis C virus (HCV) infection: HCV-RNA
                    detection in PBMC of plasma viremia-negative HCV-seropositive persons. Infection 26, 151-
                    154.
              18.   C. Reinhard, B. Shamoon, V. Shyamala, and L. T. Williams (1997) Tumor Necrosis factor
                    alpha induced activation of c-jun N-terminal kinase is mediated by TRAF2. EMBO J. 16,1080-
                    1092.
              19.   M. E. Wernette-Hammond, V. Shyamala, M. A. Siani, C. A. Gallegos,, P. H. Feucht, J. Abbott,
                    G. Reza-Lapointe, M. Moghadam, H. Khoja, J. Zakel, and P. Tekamp-Olson (1996) Receptor
                    recognition and specificity of interleukin-8 is determined by residues that cluster near a surface-
                    accessible hydrophobic pocket. J. Biol. Chem. 271, 8228-8235.
              20.   V. Shyamala, T. H. M. Moulthrop, J. Stratton-Thomas, and P. Tekamp-Olson (1994) Two
                    distinct human endothelin B receptors generated by alternative splicing from a single gene. Cell.
                    Mol. Biol. Res. 40, 285-296.
              21.   F. Damacco, D. Sansonno, J. H. Han, V. Shyamala, V. Cornacchiulo, A. R. Iacobelli, G.
                    Lauletta, and R. Rizzi (1994) Natural interferon-alpha versus its combination with 6-methyl-
                    prednisolone in the therapy of type II mixed cryoglobulinemia: a long-term, randomized,
                    controlled study. Blood 84, 3336-3343.
              22.   L. J. van Doorn, V. Shyamala, J. H. Han, and G. E. Kleter (1994) HCV RNA detection in
                    heparinized blood by direct genomic RNA capture onto paramagnetic particles. J. Virol. Meth.
                    48, 339-341.
              23.   S. Magrin, A. Craxi, C. Fabiano, G. Florentino, L. Marino, P. Almasio, G. B. Pinzello, U.
                    Palazzo, M. Vitale, A. Maggio, G. Bucca, F. Gianguzza, V. Shyamala, J. H. Han, and L.
                    Pagliaro (1992) Serum hepatitis virus (HCV)-RNA and response to alpha-interferon in anti-
                    HCV positive chronic hepatitis. J. Med. Virol. 38, 200-206.


V. Shyamala                                           4                                             7/26/2012
24. J. H. Han, V. Shyamala, K. H. Richman, M. J. Brauer, B. Irvine, M. S. Urdea, P. Tekamp-
                   Olson, G. Kuo, Q.-L. Choo, and M. Houghton (1991) Characterization of the terminal regions
                   of hepatitis C viral RNA: Identification of conserved sequences in the 5' untranslated region
                   and poly(A) tails at the 3' end. Proc. Natl. Acad. Sci. USA 88, 1711-1715.
               25. A. J. Weiner, C. Christopherson, J. Eric Hall, F. Bonino, G. Saracco, K. Crawford, C. D. Marion,
                   K. A. Crawford, V. Shyamala, T. Miyamura, J. McHutchinson, T. Cuypers and M. Houghton
                   (1991) Sequence variation in hepatitis C viral isolates. J. Hepatology 13, 6-14.
               26. R. V. Webster, J. C. Craig, V. Shyamala, G. C. Kirby, and D. C. Warhurst (1991) Antimalarial
                   activity of optical isomers of quinacrine dihydrochloride against chloroquine-sensitive and -
                   resistant plasmodium falciparum in vitro. Biochem. Pharmacol. 42, S225-S227
               27. V. Shyamala, V. Baichwal, E. Beall, and G. F.-L. Ames (1991) Structure-function analysis of
                   the histidine permease and comparison with cystic fibrosis mutations. J. Biol. Chem. 266,
                   18714-18719.
               28. R. E. Kerppola, V. Shyamala, P. Klebba, G. F.-L. Ames (1991) The membrane-bound
                   proteins of periplasmic permeases form a complex. Identification of the histidine permease
                   HisQMP complex. J. Biol. Chem. 266, 9857-9865.
               29. V. Shyamala, and G. F.-L. Ames (1991) Use of exonuclease for rapid polymerase-chain-
                   reaction-based in vitro mutagenesis. Gene 97, 1-6.
               30. V. Shyamala, E. Schneider, and G. F. L. Ames (1990) Tandem chromosomal duplications: Role
                   of REP sequences in the recombination event at the join-point. EMBO J. 9, 939-946.
           29. 31. V. Shyamala, and G. F.-L. Ames (1989) Genome walking by single-specific-primer polymerase
                   chain reaction: SSP-PCR. Gene 84, 1-8.
           30. 32. V. Shyamala, and G. F.-L. Ames (1989) Amplification of bacterial genomic DNA by the
                   polymerase chain reaction and direct sequencing after asymmetric amplification: application to
                   the study of periplasmic permeases. J. Bacteriol. 171, 1602-1608.

Selected        1.   V. Shyamala, and G. F.-L. Ames (1993) Genome walking by Single-Specific Primer Polymerase
Invited              Chain Reaction, in Methods in Enzymol. Vol. 217 Part H, pp 436-446. Ed. R. Wu.
Articles        2.   V. Shyamala, and G. F.-L. Ames (1993) Single-Specific Primer Polymerase Chain Reaction and
                     Gene walking, in PCR protocols Current methods and applications, Vol. 15, pp 339-348. Ed. B.
                     White
                3.   A. J. Weiner, V. Shyamala, J. Eric Hall, M. Houghton, and J. Han (1992) Application of
                     polymerase chain reaction to hepatitis C virus research and diagnostics, in Diagnosis of human
                     viruses by polymerase chain reaction technology. pp 86-100.

Poster                65th Annual AABB meeting, 2012, 6th -9th October, Boston MA
Presentation    1.    K. Chatterjee, V. Shyamala. Procleix Ultrio Plus Assay Evaluation Experience for Indian donor
2000-2012             population. Transfusion 52,
                      32nd Congress of the ISBT, 2012, 7th-12th July, Cancun, Mexico
                2.    V. Shyamala, Karnataka State Government, Bangalore Medical Systems. Public Private
                      Partnership for Statewide consolidation and Centralized Individual Donation Nucleic Acid
                      Testing in India: Karnataka State Experience. Vox Sanguinis 103, 77.
                      40th Annual Oakridge Conference, 2008, 17th -18th April San Jose, CA
                3.    F. Benahmed, J. Simpson, N. Chakraborty, I. Mielzynska, K. Modarress, T. Hazel, V. Shyamala
                      A rapid, sensitive, specific assay for the detection of Chlamaydia trachomatis in urine by the
                      CANARYR assay.
                      59th Annual AABB meeting, 2006, 21st -24th October, Miami Beach, FL
                4.     Y.-L. Fong, D. Madriaga, V. Shyamala, J. Cottrell, R. Lewis, L. Eudey, G. Crutcher, N. Lelie,
                       A. Heaton, B. Phelps, D. Chien. Evaluation of Analytical Sensitivity of Chiron Target Capture
                       HBV DNA Assay for HBV Detection, and Comparison with NGI SuperQuant TM HBV DNA
                       Assay. Transfusion 46, 96.
                5.    S. Kleinman, T. H. Lee, L. Montalvo, L. H. Tobler, S. A. Glynn, D. S. Todd, V. Shyamala, D.
                      Madriaga, J. E. Kiss, M. P. Busch. Prevalence and Quantitation of Parvovirus B19 DNA Levels
                      in Blood Donors Using a Sensitive PCR Screening Assay. Transfusion 46, 37.
                     25th Annual meeting of American Society of Virology, 2006, 15 th -19th July, Madison, WI
                6.    V. Shyamala, B. Hjelle, D. Madriaga, H. Huang, S. Nguyen, D. Chien, B. Phelps, S. Pichuantes.



V. Shyamala                                          5                                            7/26/2012
Multiplex detection and quantitation of six subtypes of Hantavirus RNA. Abstract W53-1, p210.
                 58th Annual AABB meeting, 2005, 15th -18th October, Seattle, WA
              7. J. Cline, C. Deza, R. Cory, A. Garcia, M. Lewis, A. Broulik, M. Deras, V. Shyamala, S.
                  Pichuantes, C. Giachetti, J. M. Linnen. Stability of WNV Viral RNA from tissue culture and
                  blood donor samples in stored blood. Transfusion 45, 149.
              8. L. H. Tobler, V. Shyamala, J. Saldhana, C. Cameron, R. Lanciotti, R. Smith, I. Walsh, B.
                  Munneke, B. H. Phelps, D. Chien, M. P. Busch. West Nile virus (WNV) viral load comparison
                  study. Transfusion 45, 151.
              9. S. Nguyen, V. Shyamala, H. Huang, D. Madriaga, M. Badgett, J. Hedges, C. WalkerPeach, D.
                  Chien, B. Phelps, S. Pichuantes. Cloning of West Nile virus internal control and nucleotide
                  fragments spanning the full-length viral genome for production of stable RNA standards.
                  Transfusion 45, 151.
                2005 National conference on West Nile Virus, 8th -9th February, San Jose, CA
              10. S. Cagliotti, G. F. Robertson, J. McAuley, S. H. Kleinman, L. H. Tobler, H. Kamel, J. M.
                   Linnen, V. Shyamala, P. A. Tomasulo, M. P. Busch. Screening the blood supply for West Nile
                   Virus RNA by nucleic acid amplification testing.
              11. M. P. Busch, L. H. Tobler, J. McAuley, J. M. Linnen, V. Shyamala, G. F. Robertson, D. J.
                   Wright, S. H. Kleinman, S. Cagliotti. West Nile virus RNA dynamics and antibody evolution
                   based on Follow-up of viremic blood donors.
              12. L. H. Tobler, V. Shyamala, J. Saldhana, C. Cameron, R. Lanciotti, R. Smith, I. Walsh, B.
                   Munneke, B. H. Phelps, D. Chien, M. P. Busch. West Nile virus (WNV) viral load comparison
                   study.
                 57th Annual AABB meeting, 2004, 23rd -26h October, Baltimore, MD
              13. V. Shyamala, D. Madriaga, S. Pichuantes, B. Jaitner, D. Chien and B. Phelps. Performance
                  characteristics of the Validated and Improved qualitative and quantitative Target-Capture PCR
                   WNV NAT assays. Transfusion 44, 140.
              14. V. Shyamala, P. Arcangel, J. Cottrell, D. Coit, A. Medina-Selby, C. McCoin, D. Chien, B.
                  Phelps. Performance characteristics of the qualitative and quantitative Target-Capture PCR HBV
                  NAT assay. Transfusion 44, 85.
              15. V. Shyamala, J. Cottrell, D. Madriaga, P. Arcangel, M. Hartman, K. Gasuad, D. Chien, B.
                  Phelps. Quantitation of commercially available nucleic acid amplification Run controls, and
                  Standards by Target-Capture PCR assay. Transfusion 44, 91.
              16. M. Busch, L. Tobler, J. McAuley, J. Linnen, V. Shyamala, G. Robertson, D. Wright, S.
                  Kleinman, S. Cagliotti. West Nile Virus RNA dynamics and anttibody evolution based on
                  follow-up of viremic blood donors. Transfusion 44, 2.
              17. J. Cline, M. Lewis, W. Wu, S. Miller, A. Broulik, J. Savage, V. Shyamala, M. Cass, C.
                  Giachetti, J.M. Linnen. Gen-Probe Alternative WNV assay: A TMA-based confirmatory assay
                  for West Nile Virus. Transfusion 44, 138.
                 28th congress of the ISBT meeting, 2004, 10th-15th July, Edinburgh, UK.
              18. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H.
                  Huang, A. Medina-Selby, D. Coit, D. Chien B. Phelps. Performance characteristics of the
                  qualitative and quantitative Target-Capture PCR WNV NAT assay. Vox Sanguinis, 87, 26.
              19. L. H. Tobler, H. Prince, G. Hafner, B. Dille, R. A. Gutierrez, W. Andrews, C. Harrington, V.
                  Shyamala, J. McAuley, V. Winkelman, S. Cagliotti, M. P. Busch. Relative performance of four
                  West Nile Virus antibody assays in viremic blood donor specimens. Vox Sanguinis, 87, 65.
                 XII APISBT, 2003 15th –18th November, New Delhi, India
              20. V. Shyamala, P. Arcangel, D. Madriaga, D. Chien, and B. Phelps. Detection and Quantitation of
                  HCV RNA by Bead capture-TaqMan technology.
                56th Annual AABB meeting, 2003, 1st-4th November, San Diego, CA
              21. V. Shyamala, J.Cottrell, P. Archangel, D. Coit, A. Medina-Selby, C. McCoin, J. Turczyn, D.
                    Chien and B. Phelps. Validation Of Alternative NAT HBV Assay: A Highly Sensitive PCR
                    Based Assay For HBV DNA. Transfusion. 43, 125.
              22. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H.
                 Huang, A. Medina-Selby, D. Coit, C. McCoin, D. Chien, B. Phelps. Detection and Quantitation
                 of West Nile Virus RNA by the Alternative NAT WNV Assay. Transfusion. 43, 128.
              23. B. Jaitner, V. Shyamala, S. Nguyen, H. Huang, Y-L Fong, D. Chien, B. Phelps, S. Pichuantes.



V. Shyamala                                       6                                          7/26/2012
Propagation, quantitation, and inactivation of West Nile Virus to support nucleic acid and IgM
                 assay development. Transfusion. 43, 128.
              24. V. Shyamala, P. Arcangel, D. Madriaga, J. Cottrell, J. Linnen, D. Chien, B. Phelps.
                   Compatibility of ProcleixR-West Nile Virus (WNV) assay in various anticoagulants. Transfusion.
                   43, 129.
                10th EPFA/NIBSC workshop & SoGAT meeting, 2003, 3 rd-4th July, Langen, Germany
              25. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H.
                   Huang, A. Medina-Selby, D. Coit, C. McCoin, D. Chien, B. Phelps. Use of quantitative NAT
                   assay to correlate West Nile Virus titration bioassasy (pfu/ml) with genomic copy numbers
                   (geq/mL).
                55th Annual AABB meeting, 2002, 26th-29th Oct. Orlando, FL
              26. S. Pichuantes, V. Shyamala, H. Huang, S. Nguyen, D. Madriaga, D. Chien, B. Phelps.
                   Identification and characterization of nucleic acid positive sera from Indonesian and Chilean
                   patients with acute hepatitis A infections. Transfusion, 42, 90.
              27. V. Shyamala, D. Madriaga, J. Cottrell, S. Pichuantes, D. Chien, B. Phelps. Development of a
                   Parvovirus B19 nucleic acid quantitative confirmatory assay for use in blood donor screening.
                   Transfusion, 42, 90.
                27th congress of the ISBT meeting, 2002, 24th-28th August, Vancouver, Canada.
              28. V. Shyamala, P. Arcangel, J. Cottrell, J. Linnen, C. Giachetti, D. Chien, B. Phelps. Performance
                   characteristics of hepatitis B virus DNA confirmatory assay for Procleix R triplex assay. Vox
                   Sanguinis, 83, 183.
              29. V. Shyamala, D. Madriaga, S. Pichuantes, D. Chien, B. Phelps. Performance characteristics of
                   PCR based Parvovirus B19 nucleic acid testing confirmatory assay for the Procleix R Parvovirus
                   B19/Hepatitis A virus assay. Vox Sanguinis, 83, 44.
              30. S. Pichuantes, H. Huang, S. Nguyen, A. Gaggerro, M. Pena, C. Larranaga, V. Shyamala, D.
                   Madriaga, D. Chien, B. Phelps. Identification and characterization of parvovirus B19 from
                   Chilean clinical specimens. Vox Sanguinis, 83, 54.
              31. J. Linnen, A. Umali, A. Broulik, D. Kolk, J. Dockter, S. McDonough, V. Shyamala, J. Cottrell,
                   P. Arcangel, L. Mimms and C. Giachetti. Effect of donor mini-pool size on closure of the HBV
                   detection window: A comparison of Triplex TMA to surface antigen detection. Vox Sanguinis,
                   83, 42.
                11th Regional Western Pacific Congress of ISBT, 2001, 10th-13th Nov. Shanghai, China.
              32. J. Linnen, M. Ho-Sing-Loy, M. Miyano, V. Shyamala, D. Kolk, A. Broulik, A. Menez, A.
                   Vaughn, E. Peterson, D. Chien, B. Phelps, L. Mimms, C. Giachetti. Performance of the Chiron
                   ProcleixR Triplex Assay for simultaneous detection of HIV-1, HCV and HBV.
                54th Annual AABB meeting, 2001, 13th-17th Oct. San Antonio, TX.
              33. J. Linnen, M. Ho-Sing-Lloy, M. Miyano, D. Kolk, A. Menez, A. Vaughn, E. Peterson, V.
                   Shyamala, P. Arcangel, D. Chien, B. Phelps. Performance of the TMA Triplex Assay which
                   simultaneously detects HIV-1, HCV and HBV nucleic acid. Transfusion, 41, 82.
              34. L. H. Tobler, J. M. Vargo, K. M. Smith, D. Hirschkorn, J. Heitman, C. Degula, V. Shyamala, D.
                   Chien, B. Phelps, L. Mimms, M.P.Busch. Sensitivity and Specificity of an HCV supplemental
                   NAT assay. Transfusion, 41, 83.
              35. V. Shyamala, S. Brentano, M. Batranina, S. Pichuantes, D. Madriaga, D. Chien, B. Phelps.
                   Detection of Parvovirus in human plasma samples by Nucleic Acid Amplification Technology
                   (NAT) Transfusion, 41, 86.
                VIIth European congress of the ISBT meeting, 2001,15 th-18th July, Paris, France
              36. V. Shyamala, D. Chien, S. Nguyen, N. Lagwinski, D. Madriaga, P. Carmichael, B. Phelps. J.
                   Heitman, D. Hirschkorn, L. Tobler, and M. Busch. Development and Evaluation of Alternative
                   NAT assay: a highly sensitive RT-PCR based diagnostic assay for HCV RNA.
              37. S. Pichuantes, H. Huang, S. Nguyen, V. Shyamala, D. Madriaga, D. Chien and B. Phelps. PCR
                   amplification, cloning, DNA sequencing and quantitation of parvovirus B19 from human IgM
                   positive sera.
                AACC meeting, 2000, 16th-18th Nov, Anaheim, CA.
              38. V. Shyamala, D. Madriaga, D. Chien and B. Phelps. A highly sensitive, TMA and PCR dual
                   amplification assay for the detection of Hepatitis C viral RNA molecules.




V. Shyamala                                       7                                            7/26/2012

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Expert Consultant in Molecular Diagnostics

  • 1. Venkatakrishna Shyamala, Ph. D. Molecular Diagnostics and Blood Testing (>25 years Biotech experience) E-mail: vshyamala@netscape.net ; Web Contact: http://www.linkedin.com/in/vshyamala Country of Citizenship: United States of America RESEARCH AND WORK EXPERIENCE Independent Consultant 10/2008 Consultant, Molecular in vitro Diagnostics, Blood Screening and Molecular Biology To Present  Consultant – Novartis Vaccines and Diagnostics, Scientific Affairs; Achira Labs Inc., India; Reuters Insight Expert, Zintro Expert  CLSI Area committee for Molecular Methods-Observer; subcommittee participant for “Point-of- Care Testing for Infectious Diseases”, “Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine” and “Microarrays for diagnosis and Monitoring of Infectious Diseases”.  CLSI publications: MM01 (2012)- Molecular Methods for Clinical Genetics and Oncology testing 3rd Ed.; MM19 (2011) Establishing Molecular Testing in Clinical Laboratory Environments; MM09 (2010) Quantitative Molecular Methods for Infectious Diseases 2nd Ed. At Innovative Biosensors, Inc., Rockville, Maryland 7/2007 To Senior Vice President, Research and Development; Clinical Diagnostics on CANARY TM platform, 10/2008 Next generation technologies  2 provisional patent applications  Leading a team of 10 scientists tasked to facilitate developing and launching Diagnostics assays for MRSA, Chlamydia trachomatis and Group B Streptococcus; Feasibility evaluation of Next Generation technologies.  Initiated Pilot Clinical trial studies at Indiana University and UM Shock Trauma Center for the CANARYTM-MRSA assay and CANARYTM-Chlamydia assays.  3 year NSF-MASINT grant to develop Hand-held Biosensors in collaboration with the Engineering department at Univ of Maryland at College Park. At Digene Corporation, Gaithersburg, Maryland 3/2006 To Director; Assay Development, Next Generation Platform Technologies for Nucleic Acid Detections 7/2007 of HPV, CT and NG 5 Invention Disclosures  Leading a team of 14 scientists tasked to facilitate development of Next Generation assay for Chlamydia trachomatis and Neisseria gonorrhoea.  Completed Analytical Sensitivity comparison of commercially available nucleic acid detection assays including Roche, GenProbe, and Abbott for 16 serovars of CT with Digene Hybrid CaptureR, Digene Isothermal and Digene Helicase Dependent Amplification assays. Chiron Corporation 1990-2006 At Chiron Corporation-Blood Testing Division, Emeryville, California 6/2004 To Associate Director; Research Leader of the Next Generation Platform Technologies for Nucleic Acid 3/2006 Detections of HBV, HCV, WNV, Parvo B19 and HAV for Blood Screening. 5 publications, 9 presentations at Scientific conferences.  Leading a team of 3 scientists and several research associates to quickly evaluate and identify the best amongst 10 Nucleic acid isolation technologies in the newly assigned project. Established collaborations with 8 companies and tested in-house, novel amplification-detection technologies. Have been a liaison as assay development expert to other departments, affiliates and customers in the existing and new product related questions. year NSF grant to develop a diagnostic assay for the detection of Hanta Virus in collaboration with Univ of Arizona. 4/2000 To Senior Scientist-Associate Director; Research Leader and Project Team Leader of the PCR based 6/2004 Alternative NAT assays for HBV, HCV and WNV for Blood Screening. 5 publications, 4 patents, 27 presentations at Scientific conferences.  Led and managed assay development teams for HBV, HCV and WNV Tests; research and development activities, including optimizations of assay reagents and test system, and transfer of product to Reference Testing Laboratories. V. Shyamala 1 7/26/2012
  • 2.  Worked in liaison with Validation, Statistics, Marketing/Business Development, Regulatory- Clinical affairs & Scientific affairs to design and execute Market evaluations, Registration studies.  Identified, negotiated and placed the Confirmatory Alternative assays for HBV and WNV in the GMP qualified Bayer Reference and Testing Laboratories (BRTL), and the HCV assay at Blood Systems Research Institute (BSRI).  Played a key role in IND and BLA submissions of Procleix-Duplex (HCV) and Procleix-Ultrio (HBV) in confirming the Clinical trial positives. Key role in IND submission of Procleix-WNV assay. Helped the Regulatory Affairs to review the Clinical report for Procleix-Ultrio for CE Mark and FDA submission and approval.  Participated in several Coded studies offered by US and Canadian Blood banks, CBER (USA), QCMD (UK), ISS & EQA (Italy) and VQC (Netherlands) for HCV, HBV and WNV Qualitative and Quantitative assays. Publication and presentation of these data, resulting in numerous collaborations.  Interfaced with Chiron Legal department to research on competitor marketed HIV and HCV assay reagents. At Chiron Corporation -Technologies Division, Emeryville, CA 1/1996 To Principal Scientist, Coordinated the efforts of scientists from various disciplines including 10/2000 chemistry, high-through put screening and phage display to examine the effect of ligand dimerization on receptor activation. Generated cell lines overexpressing recombinant and chimeric receptor. Set up ligand binding and signaling assays for high through-put screening. Identified novel orphan receptors, and determined their expression profile. 6/1994 To Research Scientist. Analyzed signaling by tumor necrosis factor receptors I and II. Identified 1/1996 kinase interacting proteins by the yeast two hybrid system. Identified novel, alternatively spliced endothelin B receptor. Defined features of IL-8 to interact and signal with IL-8 receptors 1 and 2. Defined signaling molecules for IL-8 receptors. Identified and isolated several novel orphan seven transmembrane receptors. 6/1990 To Research Biochemist, Identified conserved sequences in the 5’ and 3’ region of Hepatitis C viral 6/1994 RNA. Developed an internal standard RNA for RT-PCR based quantitation of hepatitis C viral RNA in tissue samples. Examined the translational control by the untranslated 5’ end of HCV RNA. Post-Doctoral Experience 1986-1990 Visiting Scientist Department of Biochemistry, University of California at Berkeley, CA. Developed PCR based methods for gene analysis. Studied structure-function relationship of the bacterial histidine permease and recombination events. 1984-1986 Scientist. Pacific Presbyterian Hospital, San Francisco, CA. 1983-1984 Post Doctoral Fellow (with Dr. J. Inselburg). Dartmouth College, Hanover, NH. 1979-1983 Post Doctoral Fellow (with Dr. H. W. Dickerman) NY State Department of Health Albany, NY. EDUCATION 1973-1979 Ph.D., Department of Biochemistry, Indian Institute of Science, Bangalore, India. Thesis: Effect of starvation on rat liver organelles. AREAS OF EXPERTISE Background Ph.D. in Biochemistry and Molecular Biology Assay Evaluated Nucleic Acid Testing (NAT) technologies, extensive virology and bacteriology experience, Development Primer/probe designs and NAT assay development; Strong troubleshooting skills and innovative and Technical thinking; Novel NAT detection methods, cDNA library screening, molecular cloning, sequencing and expression. Scientific Developed and maintained contacts with key external opinion leaders, clinical investigators, and Affairs other key customers in blood screening and diagnostic field; Marketing study designs; Authored several original publications; Presented scientific data at numerous professional conferences; Solid V. Shyamala 2 7/26/2012
  • 3. knowledge and experience on assay development and product improvements; Critical data analysis and interpretation. Recruited subject experts to IBI Scientific Advisory Board, monthly progress presentations to Board members, procured NSF-MASINT and NIH grant. Other Areas Reviewed Clinical trial data for IND and BLA preparation and submission; B round financing of $12 million for IBI; IRB procurement to initiate pilot MRSA clinical studies EXTRA MURAL FUNDING 2008-2010 3 year NSF-MASINT grant to develop Hand-held Biosensors in collaboration with the Engineering department at Univ of Maryland at College Park. 2003-2007 year NSF grant to develop a diagnostic assay for the detection of Hanta Virus in collaboration with Univ of Arizona. 2007-2008 Invited reviewer by NSF for the Ohio State interdisciplinary grant. SELECTED PUBLICATIONS Patents Patents: Issued/Filed 1. C. Cote, Q.-X. Zheng, V. Shyamala, T. Hazel: Methods and Systems for Detecting Methicillin- Resistant Staphylococcus (2008) PCT/US09/43143 2. V. Shyamala, S. Pichuantes and S. Nguyen: Methods and Reagents for Detecting Hantavirus (2005) WO 2008/008444 A2 3. V. Shyamala: Identification of oligonucleotides for the capture, detection and quantitation of Hepatitis A viral RNA (2003) WO2003/106641. 4. V. Shyamala: Identification of oligonucleotides for the capture, detection and quantitation of West Nile viral RNA (2002) WO2004/055159 A2; US 7,132,233 B2. 5. S. Pichuantes, and V. Shyamala: Diagnostic assays for Parvovirus B19 (2002) WO 03/002753 A2; US 6,936,442 (2005). Original 1. R. Emmadi, J.B. Boonyaratanakornkit, R. Selvarangan, V. Shyamala, B. L. Zimmer, L. Papers Williams, B. Bryant, T. Schutzbank, M. M. Schoonmaker, J. A. Amos Wilson, L. Hall, P. Since 1989 Pancholi and K. Bernard (2011) Molecular methods and platforms for infectious diseases testing. A review of FDA approved and cleared assays. J. Mol. Diagnostics 13, 583-604. 2. S. Kleinman, S. Glynn, T.-H. Lee, L. Tobler, L. Montalvo, D. Todd, J. Kiss, V. Shyamala, M. Busch (2007) Prevalence and quantitation of Parvovirus B19 DNA levels in blood donors using a sensitive PCR screening assay. Transfusion 47, 1756-1764. 3. M. Busch , S. Caglioti, G. Robertson, J. McAuley, L. Tobler , H. Kamel, J. Linnen, V. Shyamala, P. Tomasulo, and S. Kleinman (2005) Screening the blood supply for West Nile Virus RNA by nucleic acid amplification testing. New Engl. J. Med. 353, 460-467. 4. M. P. Busch, L.H. Tobler, J. Saldanha, S. Caglioti, V. Shyamala, J. Linnen, J. Gallarda, B. Phelps, R. Smith, and S. H. Kleinman (2005) Analytical and Clinical Sensitivity of First Generation West Nile Virus RNA Screening and Confirmatory Assays. Transfusion 45, 492- 499. 5. A. Cox, D. M. Netski, T. Mosburger, S.G. Sherman, S. Strathdee, D. Ompad, D. Vlahov, V. Shyamala, D. Chien, S. C. Ray and D. Thomas (2005) Prospective evaluation of community- acquired acute hepatitis C. Clin. Infect. Dis. 40, 951-958. 6. L. H. Tobler, C. Bianco, S. A. Glynn, G. B. Schreiber, B. J. Dille, H. E. Prince, R. S. Lanciotti, J. M. Linnen, J. Galarda, V. Shyamala, D. Smith, S. H. Kleinman and M. P. Busch (2005) Detection of West Nile Virus (WNV) RNA and antibody in frozen plasma components recalled from the 2002 peak epidemic. Transfusion 45, 480-486. 7. V. Shyamala, P. Arcangel, J. Cottrell, D. Coit, A. Medina-Selby, C. McCoin, D. Madriaga, D. Chien and B. Phelps (2004) Assessment of the Target-Capture PCR Hepatitis B Virus (HBV) DNA Quantitative Assay and Comparison with Commercial HBV DNA Quantitative Assays. J. Clin. Microbiol. 42, 5199-5204. V. Shyamala 3 7/26/2012
  • 4. 8. G. Pisani, K. Cristiano, J. Saldanha, M. Wirz, G. M. Bisso, C. Mele, G. Gentili and the EQA Participants. (2004) External quality assessment for the detection of blood-borne viruses in plasma by nucleic acid amplification technology: the first human immunodeficiency virus and hepatitis B virus studies (HIV EQA/1 and HBV EQA/1) and the fifth hepatitis C virus study (HCV EQA/5). Vox Sanguinis 87, 91-95. 9. V. Shyamala, J. Cottrell, P. Arcangel, D. Madriaga, J. Linnen, B. Phelps, and D. Chien (2004) Detection and quantitation of HBV DNA in the WHO International standard for HIV-1 RNA. J. Virol. Meth. 118, 69-72. 10. C. Gentili, G. Pisani, J. Saldhana, K. Cristiano, Wirz, G. M. Bisso, C. Mele, and the EQA participants. (2003) High proficiency in detecting the six major hepatitis C virus genotypes of laboratories involved in testing plasma by nucleic acid amplification technology. Vox Sanguinis 85, 114-116. 11. J.-P. Allain, D. Candotti, K. Soldan, F. Sarkodie, B. Phelps, C. Giachetti, V. Shyamala, F. Yeboah, M. Anokwa, S. Owusu-Ofori, and O. Opare-Sem (2003) The risk of hepatitis B virus infection by transfusion in Kumasi, Ghana. Blood 101, 2419-2425. 12. H. Khoja, G. Wang, C.-T. Lee Ng, J. Tucker, T. Brown, and V. Shyamala (2000) Cloning of CCRL1, an orphan seven transmembrane receptor related to chemokine receptors, expressed abundantly in the heart. Gene 246, 229-238. 13. M.D. Ballinger, V. Shyamala, L. D. Forrest, M. Deuter-Reinhard, L.V. Doyle, J. X. Wang, L. Panganiban-Lustan, J. R. Stratton JR, G. Apell, J. A. Winter, M. V. Doyle, S. Rosenberg, W.M. Kavanaugh (1999). Semirational design of a potent, artificial agonist of fibroblast growth factor receptors. Nat. Biotechnol. 17, 1199-1204. 14. V. Shyamala, H. Khoja, M. L. Anderson, J.-X. Wang, H. Cen, and W. M. Kavanaugh (1999) High-throughput screening for ligand-induced c-fos mRNA expression by branched DNA assay in chinese hamster ovary cells. Anal. Biochem. 266, 140-147. 15. V. Shyamala, and H. Khoja (1998) Interleukin-8 receptors R1 and R2 activate mitogen- activated protein kinases and induce c-fos, independent of Ras and Raf-1 in chinese hamster ovary cells. Biochemistry 37, 15918-15924. 16. V. Shyamala, H. Khoja, and M. Moghadam (1998) Inhibition of adenylyl cyclase by  chemokines IL-8 and GRO- in chinese hamster ovary cells expressing R1 and R2 receptors. J. Interferon Cytokine Res. 18, 235-239. 17. C. Caudai, M. G. Padula, I. Bastianoni, P. E. Valensin, V. Shyamala, J. Han, C. A. Boggiano, P. Almi (1998) Antibody testing and RT-PCR in hepatitis C virus (HCV) infection: HCV-RNA detection in PBMC of plasma viremia-negative HCV-seropositive persons. Infection 26, 151- 154. 18. C. Reinhard, B. Shamoon, V. Shyamala, and L. T. Williams (1997) Tumor Necrosis factor alpha induced activation of c-jun N-terminal kinase is mediated by TRAF2. EMBO J. 16,1080- 1092. 19. M. E. Wernette-Hammond, V. Shyamala, M. A. Siani, C. A. Gallegos,, P. H. Feucht, J. Abbott, G. Reza-Lapointe, M. Moghadam, H. Khoja, J. Zakel, and P. Tekamp-Olson (1996) Receptor recognition and specificity of interleukin-8 is determined by residues that cluster near a surface- accessible hydrophobic pocket. J. Biol. Chem. 271, 8228-8235. 20. V. Shyamala, T. H. M. Moulthrop, J. Stratton-Thomas, and P. Tekamp-Olson (1994) Two distinct human endothelin B receptors generated by alternative splicing from a single gene. Cell. Mol. Biol. Res. 40, 285-296. 21. F. Damacco, D. Sansonno, J. H. Han, V. Shyamala, V. Cornacchiulo, A. R. Iacobelli, G. Lauletta, and R. Rizzi (1994) Natural interferon-alpha versus its combination with 6-methyl- prednisolone in the therapy of type II mixed cryoglobulinemia: a long-term, randomized, controlled study. Blood 84, 3336-3343. 22. L. J. van Doorn, V. Shyamala, J. H. Han, and G. E. Kleter (1994) HCV RNA detection in heparinized blood by direct genomic RNA capture onto paramagnetic particles. J. Virol. Meth. 48, 339-341. 23. S. Magrin, A. Craxi, C. Fabiano, G. Florentino, L. Marino, P. Almasio, G. B. Pinzello, U. Palazzo, M. Vitale, A. Maggio, G. Bucca, F. Gianguzza, V. Shyamala, J. H. Han, and L. Pagliaro (1992) Serum hepatitis virus (HCV)-RNA and response to alpha-interferon in anti- HCV positive chronic hepatitis. J. Med. Virol. 38, 200-206. V. Shyamala 4 7/26/2012
  • 5. 24. J. H. Han, V. Shyamala, K. H. Richman, M. J. Brauer, B. Irvine, M. S. Urdea, P. Tekamp- Olson, G. Kuo, Q.-L. Choo, and M. Houghton (1991) Characterization of the terminal regions of hepatitis C viral RNA: Identification of conserved sequences in the 5' untranslated region and poly(A) tails at the 3' end. Proc. Natl. Acad. Sci. USA 88, 1711-1715. 25. A. J. Weiner, C. Christopherson, J. Eric Hall, F. Bonino, G. Saracco, K. Crawford, C. D. Marion, K. A. Crawford, V. Shyamala, T. Miyamura, J. McHutchinson, T. Cuypers and M. Houghton (1991) Sequence variation in hepatitis C viral isolates. J. Hepatology 13, 6-14. 26. R. V. Webster, J. C. Craig, V. Shyamala, G. C. Kirby, and D. C. Warhurst (1991) Antimalarial activity of optical isomers of quinacrine dihydrochloride against chloroquine-sensitive and - resistant plasmodium falciparum in vitro. Biochem. Pharmacol. 42, S225-S227 27. V. Shyamala, V. Baichwal, E. Beall, and G. F.-L. Ames (1991) Structure-function analysis of the histidine permease and comparison with cystic fibrosis mutations. J. Biol. Chem. 266, 18714-18719. 28. R. E. Kerppola, V. Shyamala, P. Klebba, G. F.-L. Ames (1991) The membrane-bound proteins of periplasmic permeases form a complex. Identification of the histidine permease HisQMP complex. J. Biol. Chem. 266, 9857-9865. 29. V. Shyamala, and G. F.-L. Ames (1991) Use of exonuclease for rapid polymerase-chain- reaction-based in vitro mutagenesis. Gene 97, 1-6. 30. V. Shyamala, E. Schneider, and G. F. L. Ames (1990) Tandem chromosomal duplications: Role of REP sequences in the recombination event at the join-point. EMBO J. 9, 939-946. 29. 31. V. Shyamala, and G. F.-L. Ames (1989) Genome walking by single-specific-primer polymerase chain reaction: SSP-PCR. Gene 84, 1-8. 30. 32. V. Shyamala, and G. F.-L. Ames (1989) Amplification of bacterial genomic DNA by the polymerase chain reaction and direct sequencing after asymmetric amplification: application to the study of periplasmic permeases. J. Bacteriol. 171, 1602-1608. Selected 1. V. Shyamala, and G. F.-L. Ames (1993) Genome walking by Single-Specific Primer Polymerase Invited Chain Reaction, in Methods in Enzymol. Vol. 217 Part H, pp 436-446. Ed. R. Wu. Articles 2. V. Shyamala, and G. F.-L. Ames (1993) Single-Specific Primer Polymerase Chain Reaction and Gene walking, in PCR protocols Current methods and applications, Vol. 15, pp 339-348. Ed. B. White 3. A. J. Weiner, V. Shyamala, J. Eric Hall, M. Houghton, and J. Han (1992) Application of polymerase chain reaction to hepatitis C virus research and diagnostics, in Diagnosis of human viruses by polymerase chain reaction technology. pp 86-100. Poster 65th Annual AABB meeting, 2012, 6th -9th October, Boston MA Presentation 1. K. Chatterjee, V. Shyamala. Procleix Ultrio Plus Assay Evaluation Experience for Indian donor 2000-2012 population. Transfusion 52, 32nd Congress of the ISBT, 2012, 7th-12th July, Cancun, Mexico 2. V. Shyamala, Karnataka State Government, Bangalore Medical Systems. Public Private Partnership for Statewide consolidation and Centralized Individual Donation Nucleic Acid Testing in India: Karnataka State Experience. Vox Sanguinis 103, 77. 40th Annual Oakridge Conference, 2008, 17th -18th April San Jose, CA 3. F. Benahmed, J. Simpson, N. Chakraborty, I. Mielzynska, K. Modarress, T. Hazel, V. Shyamala A rapid, sensitive, specific assay for the detection of Chlamaydia trachomatis in urine by the CANARYR assay. 59th Annual AABB meeting, 2006, 21st -24th October, Miami Beach, FL 4. Y.-L. Fong, D. Madriaga, V. Shyamala, J. Cottrell, R. Lewis, L. Eudey, G. Crutcher, N. Lelie, A. Heaton, B. Phelps, D. Chien. Evaluation of Analytical Sensitivity of Chiron Target Capture HBV DNA Assay for HBV Detection, and Comparison with NGI SuperQuant TM HBV DNA Assay. Transfusion 46, 96. 5. S. Kleinman, T. H. Lee, L. Montalvo, L. H. Tobler, S. A. Glynn, D. S. Todd, V. Shyamala, D. Madriaga, J. E. Kiss, M. P. Busch. Prevalence and Quantitation of Parvovirus B19 DNA Levels in Blood Donors Using a Sensitive PCR Screening Assay. Transfusion 46, 37. 25th Annual meeting of American Society of Virology, 2006, 15 th -19th July, Madison, WI 6. V. Shyamala, B. Hjelle, D. Madriaga, H. Huang, S. Nguyen, D. Chien, B. Phelps, S. Pichuantes. V. Shyamala 5 7/26/2012
  • 6. Multiplex detection and quantitation of six subtypes of Hantavirus RNA. Abstract W53-1, p210. 58th Annual AABB meeting, 2005, 15th -18th October, Seattle, WA 7. J. Cline, C. Deza, R. Cory, A. Garcia, M. Lewis, A. Broulik, M. Deras, V. Shyamala, S. Pichuantes, C. Giachetti, J. M. Linnen. Stability of WNV Viral RNA from tissue culture and blood donor samples in stored blood. Transfusion 45, 149. 8. L. H. Tobler, V. Shyamala, J. Saldhana, C. Cameron, R. Lanciotti, R. Smith, I. Walsh, B. Munneke, B. H. Phelps, D. Chien, M. P. Busch. West Nile virus (WNV) viral load comparison study. Transfusion 45, 151. 9. S. Nguyen, V. Shyamala, H. Huang, D. Madriaga, M. Badgett, J. Hedges, C. WalkerPeach, D. Chien, B. Phelps, S. Pichuantes. Cloning of West Nile virus internal control and nucleotide fragments spanning the full-length viral genome for production of stable RNA standards. Transfusion 45, 151. 2005 National conference on West Nile Virus, 8th -9th February, San Jose, CA 10. S. Cagliotti, G. F. Robertson, J. McAuley, S. H. Kleinman, L. H. Tobler, H. Kamel, J. M. Linnen, V. Shyamala, P. A. Tomasulo, M. P. Busch. Screening the blood supply for West Nile Virus RNA by nucleic acid amplification testing. 11. M. P. Busch, L. H. Tobler, J. McAuley, J. M. Linnen, V. Shyamala, G. F. Robertson, D. J. Wright, S. H. Kleinman, S. Cagliotti. West Nile virus RNA dynamics and antibody evolution based on Follow-up of viremic blood donors. 12. L. H. Tobler, V. Shyamala, J. Saldhana, C. Cameron, R. Lanciotti, R. Smith, I. Walsh, B. Munneke, B. H. Phelps, D. Chien, M. P. Busch. West Nile virus (WNV) viral load comparison study. 57th Annual AABB meeting, 2004, 23rd -26h October, Baltimore, MD 13. V. Shyamala, D. Madriaga, S. Pichuantes, B. Jaitner, D. Chien and B. Phelps. Performance characteristics of the Validated and Improved qualitative and quantitative Target-Capture PCR WNV NAT assays. Transfusion 44, 140. 14. V. Shyamala, P. Arcangel, J. Cottrell, D. Coit, A. Medina-Selby, C. McCoin, D. Chien, B. Phelps. Performance characteristics of the qualitative and quantitative Target-Capture PCR HBV NAT assay. Transfusion 44, 85. 15. V. Shyamala, J. Cottrell, D. Madriaga, P. Arcangel, M. Hartman, K. Gasuad, D. Chien, B. Phelps. Quantitation of commercially available nucleic acid amplification Run controls, and Standards by Target-Capture PCR assay. Transfusion 44, 91. 16. M. Busch, L. Tobler, J. McAuley, J. Linnen, V. Shyamala, G. Robertson, D. Wright, S. Kleinman, S. Cagliotti. West Nile Virus RNA dynamics and anttibody evolution based on follow-up of viremic blood donors. Transfusion 44, 2. 17. J. Cline, M. Lewis, W. Wu, S. Miller, A. Broulik, J. Savage, V. Shyamala, M. Cass, C. Giachetti, J.M. Linnen. Gen-Probe Alternative WNV assay: A TMA-based confirmatory assay for West Nile Virus. Transfusion 44, 138. 28th congress of the ISBT meeting, 2004, 10th-15th July, Edinburgh, UK. 18. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H. Huang, A. Medina-Selby, D. Coit, D. Chien B. Phelps. Performance characteristics of the qualitative and quantitative Target-Capture PCR WNV NAT assay. Vox Sanguinis, 87, 26. 19. L. H. Tobler, H. Prince, G. Hafner, B. Dille, R. A. Gutierrez, W. Andrews, C. Harrington, V. Shyamala, J. McAuley, V. Winkelman, S. Cagliotti, M. P. Busch. Relative performance of four West Nile Virus antibody assays in viremic blood donor specimens. Vox Sanguinis, 87, 65. XII APISBT, 2003 15th –18th November, New Delhi, India 20. V. Shyamala, P. Arcangel, D. Madriaga, D. Chien, and B. Phelps. Detection and Quantitation of HCV RNA by Bead capture-TaqMan technology. 56th Annual AABB meeting, 2003, 1st-4th November, San Diego, CA 21. V. Shyamala, J.Cottrell, P. Archangel, D. Coit, A. Medina-Selby, C. McCoin, J. Turczyn, D. Chien and B. Phelps. Validation Of Alternative NAT HBV Assay: A Highly Sensitive PCR Based Assay For HBV DNA. Transfusion. 43, 125. 22. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H. Huang, A. Medina-Selby, D. Coit, C. McCoin, D. Chien, B. Phelps. Detection and Quantitation of West Nile Virus RNA by the Alternative NAT WNV Assay. Transfusion. 43, 128. 23. B. Jaitner, V. Shyamala, S. Nguyen, H. Huang, Y-L Fong, D. Chien, B. Phelps, S. Pichuantes. V. Shyamala 6 7/26/2012
  • 7. Propagation, quantitation, and inactivation of West Nile Virus to support nucleic acid and IgM assay development. Transfusion. 43, 128. 24. V. Shyamala, P. Arcangel, D. Madriaga, J. Cottrell, J. Linnen, D. Chien, B. Phelps. Compatibility of ProcleixR-West Nile Virus (WNV) assay in various anticoagulants. Transfusion. 43, 129. 10th EPFA/NIBSC workshop & SoGAT meeting, 2003, 3 rd-4th July, Langen, Germany 25. V. Shyamala, S. Pichuantes, B. Jaitner, D. Madriaga, P. Arcangel, J. Cottrell, S. Nguyen, H. Huang, A. Medina-Selby, D. Coit, C. McCoin, D. Chien, B. Phelps. Use of quantitative NAT assay to correlate West Nile Virus titration bioassasy (pfu/ml) with genomic copy numbers (geq/mL). 55th Annual AABB meeting, 2002, 26th-29th Oct. Orlando, FL 26. S. Pichuantes, V. Shyamala, H. Huang, S. Nguyen, D. Madriaga, D. Chien, B. Phelps. Identification and characterization of nucleic acid positive sera from Indonesian and Chilean patients with acute hepatitis A infections. Transfusion, 42, 90. 27. V. Shyamala, D. Madriaga, J. Cottrell, S. Pichuantes, D. Chien, B. Phelps. Development of a Parvovirus B19 nucleic acid quantitative confirmatory assay for use in blood donor screening. Transfusion, 42, 90. 27th congress of the ISBT meeting, 2002, 24th-28th August, Vancouver, Canada. 28. V. Shyamala, P. Arcangel, J. Cottrell, J. Linnen, C. Giachetti, D. Chien, B. Phelps. Performance characteristics of hepatitis B virus DNA confirmatory assay for Procleix R triplex assay. Vox Sanguinis, 83, 183. 29. V. Shyamala, D. Madriaga, S. Pichuantes, D. Chien, B. Phelps. Performance characteristics of PCR based Parvovirus B19 nucleic acid testing confirmatory assay for the Procleix R Parvovirus B19/Hepatitis A virus assay. Vox Sanguinis, 83, 44. 30. S. Pichuantes, H. Huang, S. Nguyen, A. Gaggerro, M. Pena, C. Larranaga, V. Shyamala, D. Madriaga, D. Chien, B. Phelps. Identification and characterization of parvovirus B19 from Chilean clinical specimens. Vox Sanguinis, 83, 54. 31. J. Linnen, A. Umali, A. Broulik, D. Kolk, J. Dockter, S. McDonough, V. Shyamala, J. Cottrell, P. Arcangel, L. Mimms and C. Giachetti. Effect of donor mini-pool size on closure of the HBV detection window: A comparison of Triplex TMA to surface antigen detection. Vox Sanguinis, 83, 42. 11th Regional Western Pacific Congress of ISBT, 2001, 10th-13th Nov. Shanghai, China. 32. J. Linnen, M. Ho-Sing-Loy, M. Miyano, V. Shyamala, D. Kolk, A. Broulik, A. Menez, A. Vaughn, E. Peterson, D. Chien, B. Phelps, L. Mimms, C. Giachetti. Performance of the Chiron ProcleixR Triplex Assay for simultaneous detection of HIV-1, HCV and HBV. 54th Annual AABB meeting, 2001, 13th-17th Oct. San Antonio, TX. 33. J. Linnen, M. Ho-Sing-Lloy, M. Miyano, D. Kolk, A. Menez, A. Vaughn, E. Peterson, V. Shyamala, P. Arcangel, D. Chien, B. Phelps. Performance of the TMA Triplex Assay which simultaneously detects HIV-1, HCV and HBV nucleic acid. Transfusion, 41, 82. 34. L. H. Tobler, J. M. Vargo, K. M. Smith, D. Hirschkorn, J. Heitman, C. Degula, V. Shyamala, D. Chien, B. Phelps, L. Mimms, M.P.Busch. Sensitivity and Specificity of an HCV supplemental NAT assay. Transfusion, 41, 83. 35. V. Shyamala, S. Brentano, M. Batranina, S. Pichuantes, D. Madriaga, D. Chien, B. Phelps. Detection of Parvovirus in human plasma samples by Nucleic Acid Amplification Technology (NAT) Transfusion, 41, 86. VIIth European congress of the ISBT meeting, 2001,15 th-18th July, Paris, France 36. V. Shyamala, D. Chien, S. Nguyen, N. Lagwinski, D. Madriaga, P. Carmichael, B. Phelps. J. Heitman, D. Hirschkorn, L. Tobler, and M. Busch. Development and Evaluation of Alternative NAT assay: a highly sensitive RT-PCR based diagnostic assay for HCV RNA. 37. S. Pichuantes, H. Huang, S. Nguyen, V. Shyamala, D. Madriaga, D. Chien and B. Phelps. PCR amplification, cloning, DNA sequencing and quantitation of parvovirus B19 from human IgM positive sera. AACC meeting, 2000, 16th-18th Nov, Anaheim, CA. 38. V. Shyamala, D. Madriaga, D. Chien and B. Phelps. A highly sensitive, TMA and PCR dual amplification assay for the detection of Hepatitis C viral RNA molecules. V. Shyamala 7 7/26/2012