Irvington-Based Biotech Company Files Petition With FDA Over Skin Cancer-Detection Device

• Editor's note—Correction: The FDA advisory panel voted (narrowly) to recommend approval of MelaFind in November, 2010. We regret the error.

There was an interesting article in The Street on Monday about Irvington-based biotech company Mela Sciences' petition filed with the U.S. Food and Drug Administration accusing officials of not following their own regulations in the review of the comapany's product MelaFind, a skin cancer detection device.

According to the article, an FDA advisory panel voted narrowly in Nov. 2010 to recommend the FDA grant Mela permission to start selling the device, despite reviewers' opinions that risk of misdiagnosing skin cancer was too high using MelaFind. The FDA demanded the company to conduct further clinical trials before submitting another application.

But since last year, the company has changed its application only to allow dermatologist to use MelaFind, hoping the added precaution would make the government regulators change their minds.

Read the full article here on The Street.