After years of regulatory limbo, Mela Sciences wins FDA clearance for its MelaFind melanoma detection system.
More than two years, two panel reviews and one citizen's petition after Mela Sciences (NSDQ:MELA) signed on for a 6-month FDA review of its MelaFind melanoma detection system, the company won FDA clearance for the U.S. market.
The Irvington, N.Y.-based company's shares shot up 5 percent on the news, to $5.63, from last night's close at $5.39.
"The FDA approval of MelaFind marks the most important achievement in the company's history and represents a significant advance for the millions of Americans who are at risk of developing this terrible disease," president & CEO Dr. Joseph Gulfo said in prepared remarks.
It's been a good season for the company, which also won CE Mark approval in the European Union for MelaFind in September.
The FDA green light marks an end to the years-long plight that made Mela Sciences a poster child for charges of unpredictability at the FDA, culminating in a Progressive Policy Institute report, "Is the FDA Strangling Innovation?"
In July 2009, Mela Sciences submitted a pre-market approval application for the MelaFind. The company had already signed a definitive agreement with the FDA in 2004 detailing the precise path to clearance and had launched the largest melanoma trial to date to support the application.
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