PharmaGenoma’s HairDX genetic test kit receives Class I medical device designation

IRVINE, Calif. PharmaGenoma and its subsidiary HairDX on Tuesday announced that the HairDX genetic test collection kit for baldness is now listed the Food and Drug Administration as a Class I medical device.

Using the HairDX test, a physician can tell a man who tests positive for the high risk genetic variant that he has approximately a 70 percent chance of going bald. Similarly, a physician can tell a man who tests negative for the high risk genetic variant that he has approximately a 70 percent chance of not going bald. 

The test could help drive sales of Merck’s prescription hair-loss remedy Propecia, which generated $39 million in sales for the third quarter ending Sept. 30.

“A recent study demonstrated that Propecia, the only FDA approved oral prescription  medication for the treatment of male pattern baldness, is effective at preventing hair loss over a period of several years. Doctors using the HairDX genetic screening test can offer a treatment plan to prevent hair loss in men of all ages before any visible signs of hair loss,” said Sharon Keene, chief medical officer for HairDX.

“Even in a global recession, personal appearance is very important internationally, and doesn’t seem to be affected by the economy,” said HairDX chief executive officer David Teckman.

The HairDX test is available in the U.S. through participating physician offices, hair restoration surgeons, dermatologists and the Bosley hair restoration centers.