The FDA has sent Mela Sciences ($MELA) an approvable letter for its MelaFind PMA application. The company says in a statement it intends to work with the agency on the physician and patient labeling, package insert, user's guide, training program and clinical protocol for a post-approval study to obtain final approval.
MelaFind, which received CE Mark approval earlier this month, is for dermatologists to obtain additional information to make a decision whether to biopsy in cases of suspected melanoma. It is not used to confirm a clinical diagnosis of the disease.
"MelaFind has the potential to provide dermatologists with significantly more information about indeterminate pigmented skin lesions to help us when deciding on which lesions to biopsy to detect melanoma as early as possible," explains Darrell Rigel, clinical professor of dermatology at New York University Medical School. "While there have been incremental improvements in imaging tools for melanoma detection, we still primarily rely on our judgment based on a visual examination to select the lesions to biopsy; data show that this is often not enough."
Last November, an FDA advisory committee voted 8 to 7 to back Mela's skin cancer detection device. The vote came despite strongly worded statements from FDA reviewers that the clinical data backing the device, as submitted, did not support its approval.
The American Cancer Society estimates there will be 70,230 new cases of invasive melanoma and roughly 8,790 related melanoma deaths this year alone, according to a company statement.
- here's the release
- see the WSJ's take