An FDA advisory committee voted 8 to 7 to back Mela Sciences' experimental skin cancer detection device Thursday. The positive vote, as TheStreet notes, came despite strongly worded statements from FDA reviewers that the MELAFind clinical data, as submitted, did not support the device's approval. And FDA staff had criticized the company's data and said its device could be harmful if used widely, especially by non-dermatologists.
The company's shares have lost 60 percent of their value since FDA concerns were made public. The stock closed at $2.53 on November 17, down from its 52-week high of $12.24 in January, according to Reuters.
Several panel members did express some reservations. "I was very conflicted," said panelist Scott Collins. "At the end of the day, MelaFind is going to allow some people to die. Dermatologists are going to allow some people to die. I believe that MelaFind is going to help a few less people to die," he said, as quoted by Reuters. TheStreet's Adam Feuerstein said skeptics on the panel argued that the device was unnecessary or potentially harmful because of the risk of misdiagnosis, as well as the the device's low specificity, which could lead to an increase in the number of unnecessary biopsies.
Mela CEO Joseph Gulfo was positive in a statement issued after the vote. "We are extremely pleased with the results of today's panel vote and look forward to working with the FDA during its ongoing review of the MelaFind PMA application," Gulfo says. "We designed MelaFind(R) to provide clinicians with objective information that can aid their decision on whether or not to biopsy a pigmented skin lesion that has characteristics of melanoma at its earliest stage."
However, after the meeting, he told reporters that panelists were led astray by the FDA's views. "I think unfortunately, the panel got very confused because they got bad information," he said, as quoted by Reuters. "Right now, the agency has an anti-risk agenda." But he added that he is ready to work with the agency to get the device approved--something that could happen in Q1 2011.