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Bio-Techne Obtains CE Mark for Exosomal Liquid Biopsy Prostate Test

NEW YORK ─ Bio-Techne said on Tuesday that its Exosome Diagnostics business has obtained the CE mark for the firm's ExoDx Prostate test (EPI) kit, an exosomal liquid biopsy diagnostic assay, enabling its use in the European Union and other regions that accept the designation.

The Minneapolis-based firm added it will begin running the urine-based test immediately in its clinical laboratory in Munich and make it available throughout Europe through various distribution channels.

EPI is a genomic risk-assessment tool that assists physicians and their patients with determining whether a prostate biopsy is needed after an ambiguous PSA test result, thereby reducing complications from unnecessary and invasive procedures, Bio-Techne said.

The CE-marked test demonstrated comparable results to Bio-Techne's US version of the test, ExoDx Prostate, with a sensitivity of 92 percent and negative predictive value of 89 percent for ruling out clinically significant prostate cancer, Bio-Techne said. Use of the test among urologists and primary care physicians in the US continues to expand, the firm added.

"The EPI test could have important implications from an economic perspective in Europe and the UK," Chuck Kummeth, president and CEO of Bio-Techne, said in a statement. "Avoiding unnecessary biopsy procedures represents an estimated savings to the healthcare system in Europe of more than €1,000 ($1,188) per patient, in addition to added costs for treating complications."