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Bio-Techne Gets New York State Approval for Prostate Cancer Test

NEW YORK (GenomeWeb) – Bio-Techne today announced that it has received a clinical laboratory permit from the New York State Department of Health to provide its liquid biopsy-based ExoDx Prostate IntelliScore (EPI) test in the state.

As a result, the test is available to patients in all 50 states in the US.

The EPI test assists physicians in determining the need for a prostate biopsy in patients with an ambiguous prostate specific antigen (PSA) test result. It tests for three exosomal RNA biomarkers to enable physicians to assess whether a patient presenting for an initial biopsy is at greater risk for high-grade prostate cancer.

Steve Silverman, vice president and general manager at Minneapolis-based Bio-Techne, said in a statement that obtaining the New York State license is an important achievement for the Exosome Diagnostics business unit, which the firm acquired in August 2018 for up to $575 million.

He said that the firm has "seen strong adoption by urologists across the country."

Since 2017, when Exosome Diagnostics launched the EPI test from its CLIA-accredited laboratory in Cambridge, Massachusetts, the lab has processed more than 25,000 tests, Bio-Techne said.

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