About MelaFind®

MelaFind®: FDA and CE Mark Approved

The FDA has approved MELA Sciences’ MelaFind® Pre-Market Approval application for use in the United States. MELA Sciences has also been granted CE Mark approval for sale of MelaFind® in the European Union.

The FDA and MELA Sciences have agreed to the following labeled indications for use of MelaFind® in the U.S.:

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®.

MelaFind® is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the Hand-Held component of MelaFind®, 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.

Propietary Database of Pigmented Skin Lesions
The database includes in vivo multi-spectral data and corresponding histological results of over 10,000 biopsied lesions from over 7,000 patients at 40 clinical study sites world-wide. MELA Sciences believes this is the largest such database in the US and a substantial barrier to competition.

MelaFind® Pivotal Trial Results
The Company conducted numerous studies of the MelaFind® system, including the landmark MelaFind® pivotal trial, the largest prospective clinical study ever conducted in melanoma detection. For all subgroups analyzed in the pivotal study, the sensitivity of MelaFind® was greater than 95% (95% lower confidence bound) and its specificity was statistically significantly higher than that of study clinicians.  For more information about MelaFind® clinical studies, visit www.melafind.com.

The FDA has approved MELA Sciences’ MelaFind® Pre-Market Approval application for use in the United States. MELA Sciences has also been granted CE Mark approval for sale of MelaFind® in the European Union.

MelaFind® Hand-Held Cross Section

Light of 10 varying wavelengths shines from MelaFind® to acquire data from clinically atypical pigmented skin lesions.

About Melanoma
The Melanoma Challenge

Melanoma is the deadliest form of skin cancer, and accounts for 75% of all skin cancer deaths, highlighting the mortality risk compared to other forms of skin cancer. There are an estimated 130,000 new cases of melanoma diagnosed in the U.S. every year. Every 57 minutes, one person in the U.S. dies of melanoma and 16 people are diagnosed with the disease, according to the American Cancer Society (ACS).

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