Bio-Techne's prostate cancer test lands FDA breakthrough status

By LabPulse.com staff writers

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.

Biocept launches 12-gene breast cancer liquid biopsy test
Biocept has launched its 12-gene Target Selector next-generation sequencing breast panel, which analyzes both circulating tumor DNA and circulating tumor...
Grail mulls LDT option for multicancer liquid biopsy test
Grail is considering options for launching its multicancer blood test as a laboratory-developed test (LDT) through its CLIA lab, following a presentation...
Syntaphilin shines as biomarker for aggressive prostate cancer
The mitochondrial protein syntaphilin could be the key in identifying prostate cancer patients who have more aggressive disease and a poorer prognosis,...

Copyright © 2019 LabPulse.com

Last Updated np 8/2/2019 5:47:43 PM