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BRANFORD, Conn., Dec. 21, 2011 /PRNewswire/ -- HistoRx recently licensed from Yale University a new clinical diagnostic assay based on AQUA® technology. This assay enables doctors treating patients with melanoma to identify a subset of those patients who, despite having no detectable cancer in their lymph nodes, have a 40% risk of recurrence of their disease. AQUA technology is an automated, quantitative IHC testing method that enables measurement of protein biomarkers in tissue as an aid to a pathologist's diagnosis. Such precise determination of first, the location within the tumor cell and second, the amount in each location is not possible with conventional testing methods, such as standard immunohistochemistry (IHC).
The prognostic assay was developed in the laboratory of David Rimm, MD, PhD, inventor of AQUA technology and Professor of Pathology, Director of Pathology Tissue Services at the Yale School of Medicine, and may be useful in guiding treatment decisions for Stage II, node-negative melanoma patients. "After surgical resection of the tumor, if the nodes are negative, we don't have much more to offer," said Dr. Rimm. "This assay allows us to measure the risk of recurrence which can be helpful to ease patient anxiety or to prompt patients to be aggressive in follow up or even consider adjuvant chemotherapy."
There are five biomarkers analyzed in the assay, and the amounts of each were measured in total and in the separate compartments of nucleus and cytoplasm. Results are interpreted to delineate clearly between low-risk and high-risk patients; Dr. Rimm intentionally avoided creating an intermediate category which is not helpful to physician decision making. The study is described in Dr. Rimm's 2009 article in the Journal of Clinical Oncology (v. 27, n. 34, pp. 5772 – 5780) which concludes that the assay is 'an independent determinant of melanoma surviva
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