The company’s genetic test collection kit has now been registered with Japan’s Pharmaceuticals and Medical Devices Agency and the first shipments to the country are planned for January 2009.
International attention
The California-based company is getting increasing attention from international markets, according to HairDX’s Jon Boroshok.
“Medical and cosmetics companies around the world are contacting us, interested in our baldness test. It seems that even in a failing economy people are still looking after their appearance,” Boroshok told CosmeticsDesign.com.
Companies working in other markets in Asia are interested as are companies in Italy, Australia and Ireland, he added.
Within the US the collection kit is now registered as a class 1 medical device. This regulation category applies to the swab used to collect the DNA sample and does not affect how the test can be distributed, explained Boroshok.
Not direct to consumers
However, the company have decided to concentrate on the medical distribution channel and from June this year stopped selling the test direct to consumers through the internet.
This was prompted, in part, by concern over possible changes to the regulation of at-home genetic tests.
“Two of the most influential states, New York and California, were a little bit further ahead and stringent with regards to genetic testing. They didn’t want any genetic tests to be sold directly to consumers. Rather than just comply with these two states we decided to take the high road and remove it from the internet throughout the US,” he explained.
Although, for the moment, country wide regulation does not preclude the selling of such tests direct to consumers, Boroshok highlighted the fact that many nationwide regulatory changes come from New York and California.