HistoRx 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; Rimm intentionally avoided creating an intermediate category which is not helpful to physician decision making. The study is described in 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 survival,' and that it 'might be beneficial in improving the selection of stage II patients for adjuvant therapy.'
The melanoma assay expands HistoRx's clinical diagnostics portfolio, which also includes diagnostics for breast, lung and colon cancers. AQUA technology is used in the clinical diagnostic setting by Genoptix Inc. (a subsidiary of Novartis) which offers breast cancer diagnostic assays based on AQUA technology, licensed from HistoRx. AQUA analysis is also used in cancer research by more than twenty leading academic centers worldwide, is part of the clinical development plans for more than ten drug candidates from major pharma companies, and has been cited in more than 100 peer-reviewed publications.