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MD Anderson to Perform Clinical Validation Study for Rosetta Genomics' CUP Test

NEW YORK (GenomeWeb News) – Rosetta Genomics said today that the University of Texas MD Anderson Cancer Center will perform a clinical validation study for its microRNA-based test designed to locate the primary site of cancers of unknown primary origin.
The study will include 100 patients who are diagnosed with CUP and who meet other eligibility criteria. The company said it plans to submit its test for regulatory approval sometime before the end of this year.
Amir Avniel, president and CEO of Rosetta Genomics, said in a statement that validation studies such as this are “an integral part of the commercialization roadmap for our diagnostic tests, as we advance them towards use in a clinical setting.”
CUP cancers account for between three and five percent of all cancers, and they have a median survival of between six and ten months.
Around 70,000 patients in the US each year receive a CUP diagnosis, usually after undergoing “a wide range of tests … which often fail to identify the origin of the cancer,” the company said.
Gauri Varadhachary, an MD Anderson oncologist, said that a microRNA-based CUP assay “may present an alternative to current diagnostic practices.”
Varadhachary said that the study will attempt to validate the assay and compare its performance to other currently available CUP tests.

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