MORGANTOWN, W.Va., Aug. 22, 2017 /PRNewswire/ -- Protea Biosciences Group, Inc. (OTCQB: PRGB) ("Protea") announced today that it has expanded its clinical research study for its new molecular imaging test for the differential diagnosis of malignant melanoma. The study has now surpassed 250 patient samples.
The proprietary assay is based on technology that was developed jointly by Rossitza Lazova, MD, and Erin Seeley, PhD, and exclusively licensed from Yale University School of Medicine. The test identifies unique sets of proteins in standard biopsy samples that differentiate malignant melanoma from benign moles. To date the clinical study has analyzed over 200 patient samples that were classified at 96% accuracy.
"We are pleased to see the continued positive results of the expanded study," stated David Halverson, Protea's President. "These results demonstrate our ability to use our proprietary mass spectrometry-based technology, together with pathologist review, to increase overall confidence in melanoma diagnosis, especially in cases that may be difficult to diagnose with traditional microscopic methods."
Protea plans to continue to expand the total patient number as part of its Clinical Laboratory Improvement Amendments (CLIA) validation process over the course of this year.
Currently, additional testing is necessary to assess and accurately diagnose indeterminate skin biopsy samples. The results from the expanded study have shown a high degree of accuracy, indicating that the assay could be used as an objective diagnostic test for skin tissue biopsies.
Melanoma is the leading cause of death from skin disease. According to the American Cancer Society, there will be an estimated 87,110 new cases of melanoma diagnosed in the USA in 2017, and about 9,730 people are expected to die of melanoma. Definitive diagnosis of melanoma requires biopsy and experienced pathological review of the specimen. There are globally approximately three million skin biopsies annually to rule out the presence of melanoma. Complicating the diagnosis of melanoma is the understanding that many of the same histologic features can be seen in common moles.
About Protea Biosciences Group, Inc.: Protea Biosciences Group, Inc. (OTCQB:PRGB) provides innovative bioanalytical solutions to the pharmaceutical and life science industries by applying the Company's proprietary technology to identify and characterize the proteins, metabolites, lipids and other biologically-active molecules which are the byproducts of all living cells and life forms. Protea provides revolutionary capabilities that enable the identification and spatial display of biologically-active molecules in tissue and cells. Molecular imaging can be obtained without sample preparation, labeling or antibody techniques, thereby integrating for the first time direct identification of molecules with anatomic pathology. The Company is using its technology to develop a new class of diagnostics for the differential diagnosis of cancer.
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Protea is a registered trademarks of Protea Biosciences Group, Inc.