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Mela Sciences Inc. (MELA) said the Food and Drug Administration extended its review of the company's computer-assisted device that could revolutionize the way doctors screen patients for cancer.
Its shares sank 21% to $7.25 in after-hours trading as the agency, which had agreed to an expedited review of the medical-device maker's MelaFind, extended that examination for six months because of questions about the device.
Mela, previously known as Electro-Optical Sciences, said it is "actively working to respond to the agency's questions in the immediate term."
"We remain confident that MelaFind can be a valuable tool to help dermatologists detect melanoma, the deadliest form of skin cancer, at its earliest, most curable stage," said Mela President and Chief Executive Joseph Gulfo.
MelaFind consists of a hand-held imaging "gun" that emits 10 different wavelengths of light to capture images of suspect pigmented skin lesions. Because the device can see where the clinician cannot--up to 2.5 millimeters below the skin's surface--it is expected to help catch melanomas much earlier, without the need for as many biopsies, which is good news for most patients fearful about body scarring from the procedure.