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Monday, October 11, 2010   1
About DermaGenoma


  • DermaGenoma is a genetics dermatology company


  • DermaGenoma develops therapeutic and diagnostic products
    based on an individual’s genetic makeup


  • World-renowned genetic scientists


  • World-renowned hair dermatologists


  • Products sold in over 30 countries on 6 continents




Monday, October 11, 2010                                       2
Overview

  • Current product lines:


     – AcneDX - antibiotic therapy response for Acne Vulgaris


     – HairDX - screen and therapy response for Androgenetic
       Alopecia


     – CelluliteDX - screen for moderate to severe cellulite (gynoid
       lipodystrophy)


     – HerpesDX - screen for frequent herpes outbreaks


     – PsoriasisDX - screen for Psoriatic Arthritis



Monday, October 11, 2010                                               3
What is the HairDX Genetic Test?


                               Genetic Test to determine Androgen Sensitivity


   
     
                 
      


   


  •     Women with high androgen sensitivity are likely to respond to
       anti-androgen therapy for the treatment of hair loss (AGA)


  •     Women with high androgen sensitivity are at an increased risk of
       developing androgenetic alopecia (AGA)




Monday, October 11, 2010                                                        4
Science - Androgen Sensitivity



  • Androgens are the male sex hormones testosterone and
    dihydrotestosterone, which are found in smaller amounts in women


  • Androgens bind to androgen receptors in cells


  • Androgen receptor sensitivity is determined by the genetics of the
    androgen receptor


  • Androgen receptor sensitivity determines the affect of androgens on
    hair loss and anti-androgen therapy




Monday, October 11, 2010                                                  5
Science - Genetics


                                 1             2                 3             4             5




                            6        7             8         9        10           11       12



                           13        14            15            16        17           18




                            19            20            21       22        X            Y



 • Human cells contain 46 chromosomes (23 pairs)


 • X and Y are sex chromosomes


 • Women have two X chromosomes


 • Men have one X and one Y chromosome


Monday, October 11, 2010                                                                         6
Science - Genetics




 • Chromosomes are made up of DNA


 • There are four DNA bases C, A, G and T


 • Sets of three DNA bases, called codons, can
   encode amino acids, e.g., the CAG codon encodes
   the amino acid glutamine


Monday, October 11, 2010                             7
Science - Androgen Receptor


  • The androgen receptor (AR) gene is located on the X-chromosome


  • Androgen sensitivity on the AR gene is determined by the number of
    CAG repeats


  • Women have two differentially activated X-chromosomes; hence, the
    test determines the CAG repeat in the activated X-chromosome


  • Patients with few CAG repeats have an increase in androgen receptor
    activity and therefore high androgen sensitivity


  • Patients with many CAG repeats have a decrease in androgen receptor
    activity and therefore low androgen sensitivity



Monday, October 11, 2010                                                  8
HairDX Clinical Study

  • Pioneering clinical study conducted by Dr. Sharon Keene
    (2009-2010)


  • Women received 1mg/day finasteride for 6 months


  • Hair counts were used to measure finasteride response


  • Responders had a CAG score <23.5 had approximately a +24%
      change in hair counts (gain hair)


  • Non-responders had a CAG score ≥23.5 had approximately a -4%
      change in hair counts (lose hair)


  • Replicated in an independent cohort



Monday, October 11, 2010                                           9
HairDX Clinical Study




                           10

Monday, October 11, 2010        10
The HairDX Female Androgen Sensitivity Test




Monday, October 11, 2010                       11
The HairDX Test Kit - Content


  • 4 cheek (buccal) swabs


  • Return envelope


  • Instruction sheet


  • Patient information sheet


  • Service Agreement - General Terms and Conditions


  • Informed consent form




Monday, October 11, 2010                               12
How is the Test Performed?


  • The HairDX genetic test can be performed at home but we
    recommend to perform the test at your clinic


  • The test uses a cheek swabs that looks like a small toothbrush


  • Four swabs are included in the test kit to assure a sufficient
    amount of DNA is collected




Monday, October 11, 2010                                             13
How is the Test Performed?




                                You MUST follow
                              the instruction sheet
                                included with the
                                 HairDX Test Kit




Monday, October 11, 2010                              14
How is the Test Performed?

                      Make sure client
                   does NOT eat or drink
                  anything, 1 hour before
                     sample collection

  • Carefully take out the sterile swab

                    NEVER touch the swab
                     tip with your fingers

  • Swab the inside cheek for 30 seconds


  • Use 2 swabs for each side


  • Use all 4 swabs included with the kit



Monday, October 11, 2010                    15
How is the Test Performed?


                   NEVER touch the swab
                    tip with your fingers


  • Put each used sterile swab back in
    the container tube


  • Place the container tubes in the
    included envelope


  • Seal the envelope




Monday, October 11, 2010                   16
The HairDX Test - Process




 • Genetic analysis of patient samples typically takes 2 weeks


 • The genetic analysis is performed at DermaGenoma labs, the
   results are made available through a secure electronic or via fax
   (U.S. domestic only)




Monday, October 11, 2010                                               17
The HairDX Test - Timeline




                                     +/- 3 Weeks



                           +/- 1 Month




Monday, October 11, 2010                           18
Safety and Confidentiality




  • The sample collection procedure is safe


  • The sample is shipped without any personal identification


  • The DermaGenoma laboratory destroys all the samples after 30 days


  • The DermaGenoma laboratory is CLIA and HIPAA compliant -
    highest US laboratory and privacy standards




Monday, October 11, 2010                                                19
Shipping to DermaGenoma (International)




  • Storage prior to shipping to DermaGenoma should be at +4
    degrees celsius


  • Shipping to DermaGenoma should be by FedEx


  • Shipping in standard package expedited delivery (no ice)


  • Label on package to receive from DermaGenoma




Monday, October 11, 2010                                       20
Shipping to DermaGenoma (Domestic)




  • Immediately mail after the sample is collected in prepaid postage
    bubble mailer provided in the test kit




Monday, October 11, 2010                                                21
HairDX Sample Report - Positive




Monday, October 11, 2010           22
HairDX Sample Report - Negative




Monday, October 11, 2010           23
Contact Information and Q&A

               United States                        Europe, Middle East, Africa
               Phone: +1 (949) 428-2140             Phone: +32 47 725 8515
               Fax: +1 (949) 428-2142               Fax: +32 1 153 3686
               Email: info@dermagenoma.com          Email: dirks@dermagenoma.com


                                Asia, Oceania
                                Phone: + 81 80 56 86 06 03
                                Fax: +1 (949) 428-2142
                                Email: junm@dermagenoma.com




Monday, October 11, 2010                                                           24

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Hair dx Female Androgen Sensitivity test - Training Presentation

  • 2. About DermaGenoma • DermaGenoma is a genetics dermatology company • DermaGenoma develops therapeutic and diagnostic products based on an individual’s genetic makeup • World-renowned genetic scientists • World-renowned hair dermatologists • Products sold in over 30 countries on 6 continents Monday, October 11, 2010 2
  • 3. Overview • Current product lines: – AcneDX - antibiotic therapy response for Acne Vulgaris – HairDX - screen and therapy response for Androgenetic Alopecia – CelluliteDX - screen for moderate to severe cellulite (gynoid lipodystrophy) – HerpesDX - screen for frequent herpes outbreaks – PsoriasisDX - screen for Psoriatic Arthritis Monday, October 11, 2010 3
  • 4. What is the HairDX Genetic Test? Genetic Test to determine Androgen Sensitivity • Women with high androgen sensitivity are likely to respond to anti-androgen therapy for the treatment of hair loss (AGA) • Women with high androgen sensitivity are at an increased risk of developing androgenetic alopecia (AGA) Monday, October 11, 2010 4
  • 5. Science - Androgen Sensitivity • Androgens are the male sex hormones testosterone and dihydrotestosterone, which are found in smaller amounts in women • Androgens bind to androgen receptors in cells • Androgen receptor sensitivity is determined by the genetics of the androgen receptor • Androgen receptor sensitivity determines the affect of androgens on hair loss and anti-androgen therapy Monday, October 11, 2010 5
  • 6. Science - Genetics 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 X Y • Human cells contain 46 chromosomes (23 pairs) • X and Y are sex chromosomes • Women have two X chromosomes • Men have one X and one Y chromosome Monday, October 11, 2010 6
  • 7. Science - Genetics • Chromosomes are made up of DNA • There are four DNA bases C, A, G and T • Sets of three DNA bases, called codons, can encode amino acids, e.g., the CAG codon encodes the amino acid glutamine Monday, October 11, 2010 7
  • 8. Science - Androgen Receptor • The androgen receptor (AR) gene is located on the X-chromosome • Androgen sensitivity on the AR gene is determined by the number of CAG repeats • Women have two differentially activated X-chromosomes; hence, the test determines the CAG repeat in the activated X-chromosome • Patients with few CAG repeats have an increase in androgen receptor activity and therefore high androgen sensitivity • Patients with many CAG repeats have a decrease in androgen receptor activity and therefore low androgen sensitivity Monday, October 11, 2010 8
  • 9. HairDX Clinical Study • Pioneering clinical study conducted by Dr. Sharon Keene (2009-2010) • Women received 1mg/day finasteride for 6 months • Hair counts were used to measure finasteride response • Responders had a CAG score <23.5 had approximately a +24% change in hair counts (gain hair) • Non-responders had a CAG score ≥23.5 had approximately a -4% change in hair counts (lose hair) • Replicated in an independent cohort Monday, October 11, 2010 9
  • 10. HairDX Clinical Study 10 Monday, October 11, 2010 10
  • 11. The HairDX Female Androgen Sensitivity Test Monday, October 11, 2010 11
  • 12. The HairDX Test Kit - Content • 4 cheek (buccal) swabs • Return envelope • Instruction sheet • Patient information sheet • Service Agreement - General Terms and Conditions • Informed consent form Monday, October 11, 2010 12
  • 13. How is the Test Performed? • The HairDX genetic test can be performed at home but we recommend to perform the test at your clinic • The test uses a cheek swabs that looks like a small toothbrush • Four swabs are included in the test kit to assure a sufficient amount of DNA is collected Monday, October 11, 2010 13
  • 14. How is the Test Performed? You MUST follow the instruction sheet included with the HairDX Test Kit Monday, October 11, 2010 14
  • 15. How is the Test Performed? Make sure client does NOT eat or drink anything, 1 hour before sample collection • Carefully take out the sterile swab NEVER touch the swab tip with your fingers • Swab the inside cheek for 30 seconds • Use 2 swabs for each side • Use all 4 swabs included with the kit Monday, October 11, 2010 15
  • 16. How is the Test Performed? NEVER touch the swab tip with your fingers • Put each used sterile swab back in the container tube • Place the container tubes in the included envelope • Seal the envelope Monday, October 11, 2010 16
  • 17. The HairDX Test - Process • Genetic analysis of patient samples typically takes 2 weeks • The genetic analysis is performed at DermaGenoma labs, the results are made available through a secure electronic or via fax (U.S. domestic only) Monday, October 11, 2010 17
  • 18. The HairDX Test - Timeline +/- 3 Weeks +/- 1 Month Monday, October 11, 2010 18
  • 19. Safety and Confidentiality • The sample collection procedure is safe • The sample is shipped without any personal identification • The DermaGenoma laboratory destroys all the samples after 30 days • The DermaGenoma laboratory is CLIA and HIPAA compliant - highest US laboratory and privacy standards Monday, October 11, 2010 19
  • 20. Shipping to DermaGenoma (International) • Storage prior to shipping to DermaGenoma should be at +4 degrees celsius • Shipping to DermaGenoma should be by FedEx • Shipping in standard package expedited delivery (no ice) • Label on package to receive from DermaGenoma Monday, October 11, 2010 20
  • 21. Shipping to DermaGenoma (Domestic) • Immediately mail after the sample is collected in prepaid postage bubble mailer provided in the test kit Monday, October 11, 2010 21
  • 22. HairDX Sample Report - Positive Monday, October 11, 2010 22
  • 23. HairDX Sample Report - Negative Monday, October 11, 2010 23
  • 24. Contact Information and Q&A United States Europe, Middle East, Africa Phone: +1 (949) 428-2140 Phone: +32 47 725 8515 Fax: +1 (949) 428-2142 Fax: +32 1 153 3686 Email: info@dermagenoma.com Email: dirks@dermagenoma.com Asia, Oceania Phone: + 81 80 56 86 06 03 Fax: +1 (949) 428-2142 Email: junm@dermagenoma.com Monday, October 11, 2010 24