Shares of Mela Sciences (NSDQ:MELA) are on a tear today in pre-market trading on news that the FDA issued an “approvable letter” for its MelaFind skin cancer detection device.
The Irvington, N.Y.-based company is more than two years into a six-month review of its pre-market approval application for the device, which uses a multi-spectral dermascope to make under-the-skin lesions visible to physicians. In June, CEO Dr. Joseph Gulfo told MassDevice that the company was an unintended victim of the push for reforms at the FDA’s Center for Devices & Radiological Health.
“We’re collateral damage in the efforts to re-design the 510(k) program,” Gulfo told us. “I’m just being a megaphone for transparency.”
That appears to no longer be the case with the issuance of the approvable letter, according to Mela Sciences.
“The FDA’s approvable letter for MelaFind represents a monumental milestone for Mela Sciences and the millions of Americans who are at risk of developing Melanoma, the deadliest form of skin cancer,” Gulfo said in prepared remarks. “We are extremely pleased with the FDA’s decision and will work diligently to answer all open questions and finalize the post-market study protocol in the coming weeks.”
It’s been a good month for the company on the regulatory front. Earlier this month the European Union granted CE Mark approval for the device, clearing it for the markets in 27 countries overseas.
Mela Sciences and the federal watchdog agency agreed to a set of labeled indications for the MelaFind device:
The FDA and Mela Sciences have agreed to the following labeled indications for use of MelaFind in the U.S., according to a press release:
“MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of Melanoma, excluding those with a clinical diagnosis of Melanoma or likely Melanoma. MelaFind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should NOT be used to confirm a clinical diagnosis of Melanoma.”
“MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the appropriate use of MelaFind.”
“The MelaFind result is one element of the overall clinical assessment. MelaFind positive lesions (which may include malignant Melanoma, Melanoma in situ, high grade dysplastic nevi and atypical Melanocytic proliferation/hyperplasia) should be considered for biopsy; the biopsy decision of a MelaFind negative lesion should be based on the remainder of the entire clinical context. Lesions that are “non-evaluable” by MelaFind should be carefully re-evaluated for biopsy.”
“MelaFind is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e. not for use on non-pigmented or skin-colored lesions), lesions that do not contain a scar or fibrosis consistent with previous trauma, lesions where the skin is intact (i.e., non-ulcerated or non-bleeding lesions), lesions greater than 1 cm away from the eye, lesions which do not contain foreign matter, and lesions not on special anatomic sites (i.e., not for use on acral, palmar, plantar, mucosal, or subungual areas). MelaFind is not designed to detect pigmented non-Melanoma skin cancers, so the dermatologist should rely on clinical experience to diagnose such lesions.”
MELA shares were trading at $6.06 in pre-market activity this morning, up more than 90 percent from their $3.18 close Sept. 23.