HairDX Genetic Test Collection Kit Now Listed With Japanese PMDA And U.S. FDA

Main Category: Genetics
Article Date: 23 Dec 2008 - 2:00 PST

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Pharmacogenomics research and development innovator PharmaGenoma, Inc. and its subsidiary HairDX, LLC, announced that the HairDX genetic test collection kit for baldness is now listed with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and the United States Food and Drug Administration (FDA) as a Class I medical device.

The PMDA operates under the Japanese Ministry Of Health, Labor and Welfare (MHLW), and is the Japanese equivalent of the U.S. FDA, and is amongst the world's most stringent expectations of quality.

HairDX reports a growth in international business despite the current economic climate, and plans to begin shipments to Japan in January, 2009. The company continues an aggressive expansion of its international efforts and footprint in the genetic research and development in the hair loss and dermatology industry.

"Even in a global recession, personal appearance is very important internationally, and doesn't seem to be affected by the economy," says HairDX CEO David Teckman. "HairDX looks forward to continued growth as a leader in pharmagenomics research and development."

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

About HairDX, LLC

HairDX, LLC is a subsidiary of PharmaGenoma, Inc. Based in Irvine, CA, HairDX (www.hairdx.com) is an FDA registered pharmacogenomics research and development company. HairDX markets the first genetic test for male and female hair loss. The company is dedicated to the research and development of new prescription based therapies tailored to an individual's genetic make up. HairDX uses only CLIA certified laboratories (Clinical Laboratory Improvement Amendments) to perform the genetic analysis.

Among HairDX leaders is William V. Murray former Division President of the Molecular Biology Division of Applied BioSystems, Inc., who formerly served in various executive leadership positions within Medtronic, Inc., Andy Goren former CEO of MobileWise, Inc. and GeePS, Inc., David Teckman, former CEO of Sutura, Inc, a medical device company, Professor Doron Lancet, PhD, Head of the Crown Human Genome Center at the Department of Molecular Genetics, Weizmann Institute of Science, Dr. Elon Pras, Director of the Institute of Human Genetics, Sheba Medical Center in Tel-Hashomer, Israel, Sharon Keene, MD and President and Medical Director of Physician's Hair Institute, in Tucson, Arizona and nationally recognized for her pioneering work in the hair transplant field, and Elliott J. Stein, an intellectual property attorney and co-founder of GeePS, Inc.

HairDX, LLC