Mela Sciences Inc.’s (NSDQ:MELA) hand-held skin cancer detection device received a scathing review from the the Food & Drug Administration.
The Irvington, N.Y.-based company’s MelaFind, a device designed to determine whether skin moles and lesions are cancerous — potentially eliminating the need for biopsies — is scheduled for a vote by the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee this week, which could pave the way for the device’s final pre-market approval.
In documents released ahead of the panel’s review, regulators said (PDF) the risk associated with the device’s use do not outweigh the benefits of circumventing a skin biopsy. The agency wrote that "since melanoma is often a fatal disease and the standard of care is to seek early detection and biopsy on any suspicious lesion … this device has not, with the current data, demonstrated any true clinical trade off and may potentially cause more harm than good to the health of the public.”
The FDA added that "if use based on the device’s diagnostic performance reduces the number of biopsies taken, harm could ensue in the form of missed melanomas," because the device is not 100 percent sensitive. Cancerous skin lesions can sometimes spread rapidly and a missed melanoma could prove fatal, according to the report.
The agency also said that its review team does not have the data to evaluate risk versus benefit of MelaFind over the standard lesion detection of biopsies, because there isn’t data on the number of unnecessary biopsies (which the company hopes to reduce or eliminate with its device). The FDA also said that MelaFind’s performance does not significantly reduce the number of biopsies when compared to the examining dermatologist’s diagnostic performance if MelaFind use is limited to suspicious, atypical lesions.
The company claims the MelaFind procedure can help reduce, or even eliminate, the need for biopsies. A clinical trial of 1,300 patients in 2009 showed that the MelaFind’s ability to detect cancerous lesions was 2.5 times greater than a dermatologist’s, according to media reports.
Early last summer, the company, which changed its name from Electro-Optical Science Inc. in 2009, filed a public offering of about 2.2 million shares at $7.50 each to raise funds to complete the commercialization of the device. Needham & Company LLC and Leerink Swann LLC acted as joint book-running managers for the IPO, which added about $13.8 million to the company’s coffers, according to a regulatory filing.