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Genetic Test for Alopecia Approved in Europe
Posted: October 9, 2009
The HairDX Genetic Test for Hair Loss, a genetic baldness (androgenetic alopecia) test manufactured by HairDX LLC, is now available as a CE Marked product under the European In Vitro Diagnostic Directive. The announcement was made at the 18th European Academy of Dermatology and Venereology (EADV) Congress in Berlin by PharmaGenoma Inc. and its subsidiary HairDX LLC.
CE Marking is required for certain product groups to indicate conformity with the essential requirements set out in European directives. The HairDX Genetic Test For Hair Loss complies with the essential requirements of the European In Vitro Diagnostic Directive. The test provides a genetic analysis of a man's or woman's likelihood of developing androgenetic alopecia, the most common type of hair loss.
The genetic hair loss test aims to diagnose alopecia in an earlier or preclinical stage so that treatment can be initiated at a time when intervention has a greater likelihood of success. The test predicts the likelihood of an individual developing androgenetic alopecia based on polymorphisms of the androgen receptor gene. The test has a high negative predictive value and a moderate positive predictive value. The company reports that visible thinning does not occur until there has been approximately 50% hair loss in a given area. The two FDA-approved medication therapies to combat hair loss, minoxidil and finasteride, reportedly are most effective at stabilizing hair loss rather than hair re-growth.
The test currently is conducted in doctors' offices in the United States to determine the liklihood of hair loss for both men and women. The company also offers the Genetic Test for Finasteride Response.