Protea Biosciences Group, Inc. has announced that it has entered into an exclusive license agreement with Yale University for new technology to improve the differential diagnosis of malignant melanoma. The test in development makes use of a new technology known as “Proteomic Mass Spectrometry Imaging (MSI)”. The technology was developed jointly by the laboratory of Rossitza Lazova, MD, Associate Professor of Dermatology and Pathology at Yale School of Medicine and the laboratory of Erin Seeley, PhD., Clinical Imaging Principal Investigator at Protea Biosciences.
In October 2015 scientists at Yale and Protea presented the results of their first clinical study at the 52nd Annual Meeting of the American Society of Dermatopathology (ASDP), held in San Francisco, CA. The sensitivity and specificity of the new method were shown to be 99%, and the test correctly classified all cases of malignant melanoma and benign melanocytic nevi.
“We are pleased to be working with Dr. Lazova at Yale, to develop this test that employs unique protein expression profiles that discriminate between benign melanocytic nevi and malignant melanomas,” stated Steve Turner, Protea’s CEO. He added, “We believe our technology will lead to the discovery of other clinically useful protein biomarker panels that can aid in the differential diagnosis of other cancer types.”
“Mass Spectrometry Imaging is an objective and reliable method that may be helpful in difficult cases, in which rendering a definitive diagnosis of either benign nevus or malignant melanoma may be very difficult. The identification of protein expression profiles, which discriminate between benign melanocytic nevi and malignant melanomas, has led to the discovery of a set of clinically useful tumor biomarkers that can be incorporated into standard diagnostic and treatment strategies,” commented Dr. Rossitza Lazova, from the Yale School of Medicine.
Proteomic Mass Spectrometry Imaging enables the direct molecular profiling of cells and tissues; specific proteins can be identified, localized in tissue, then displayed, both as 2D or 3D molecular images. Hundreds of molecules can be identified in a single analysis, and results are rapidly available. Protea is a primary commercial provider of mass spectrometry imaging (MSI) services.
Melanoma is the leading cause of death from skin disease. One American dies every hour of melanoma. The National Cancer Institute estimates 73,870 Americans will be diagnosed with melanoma in 2015. Melanoma is the fifth most common cancer in men and the sixth most common cancer in women in the United States. Definitive diagnosis of melanoma requires biopsy and experienced pathological review of the specimen.
An established diagnosis of malignant melanoma can be made only after histopathological review. There are globally approximately three million skin biopsies annually to rule out the presence of melanoma; of these approximately 25% are “indeterminate” or “unknown”. Complicating the diagnosis of melanoma is the understanding that many of the same histologic features can be seen in benign melanocytic nevi, or common moles.