Rosetta Genomics has received approval from the New York State Department of Health to use miRview mets^2 testing on patient tumour samples.
The microRNA-based test identifies the primary origin of many types of tumours, including sarcomas, lymphomas and other non-epithelial malignancies, as well as histologic subtypes.
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Following the approval, Rosetta Genomics can offer miRview mets^2 test in all 50 US states.
Rosetta Genomics president and CEO Kenneth Berlin said that there is a pressing clinical need for more accurate identification of tumour origin, as there are around 200,000 cases of cancer of unknown primary and difficult to diagnose metastatic cancer per year in the US.
"We are very pleased to have approval to market this important cancer diagnostic to the benefit of physicians and patients in New York," Berlin added.
It provides physicians and patients a wide panel of 42 identifiable tumour origins, providing an accurate result in 85% of samples, according to a study which involved a blinded validation set of 509 samples.
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By GlobalDataThe test has also proven its efficacy in a post-marketing validation study conducted at Ruprecht-Karls University Heidelberg, Germany.
Further studies have shown that the miRview mets^2 platform can also be used to test decalcified bone specimens.
