As previously reported, NYSDOH granted conditional nod to the test in December 2013. The product is now fully approved in all 50 US states.
The test is a microRNA-based assay, which classifies the four most common kidney tumours, including clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and the benign oncocytoma. The product, having shown sensitivity and specificity of 95% and 98%, respectively, is commercialised via Rosetta's CAP-accredited and CLIA-certified lab in Philadelphia, Pennsylvania.
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