Protea Biosciences Group, Inc. is expanding its clinical research study for their new molecular imaging test for the differential diagnosis of malignant melanoma.
The study has now surpassed 250 patient samples, the company reports.
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. 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.
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.