June 20, 2019 -- Bio-Techne's ExoDx Prostate IntelliScore (EPI) liquid biopsy test for spotting aggressive prostate cancers has received the U.S. Food and Drug Administration's (FDA) breakthrough device designation.
With the test, a urine sample is evaluated using real-time quantitative reverse transcription polymerase chain reaction (PCR) technology. A higher EPI score is associated with a greater risk for high-grade prostate cancer on biopsy. The test was launched in 2017 in the U.S. by Exosome Diagnostics, which was acquired by Bio-Techne in 2018.
Bio-Techne sees the ExoDx test as useful for potentially avoiding prostate biopsies in men 50 years and older who have a prostate-specific antigen (PSA) level that is inconclusive -- i.e., between 2 ng/mL and 10 ng/mL.
In January, Bio-Techne announced that the test was incorporated into guidelines from the National Comprehensive Cancer Network (NCCN), an influential body for reimbursement, for use prior to a first biopsy or after a negative biopsy to determine the likelihood of a high-grade cancer. ExoDx also received a positive decision for Medicare coverage in the U.S. in a draft recommendation.
Bio-Techne is also using the ExoDx platform to develop liquid biopsy tests for other tumor types. The company presented results from a validation study of its liquid biopsy test for determining the mutational status of the EGFR gene in non-small cell lung cancer at the American Society of Clinical Oncology (ASCO) meeting, held May 31 to June 4 in Chicago.