- Bio-Techne said it received FDA’s breakthrough device designation for its ExoDx Prostate IntelliScore liquid biopsy test.
- The test, which analyzes a patient’s exosomes, assists physicians in determining the need for a prostate biopsy in patients with an ambiguous PSA test result.
- The Minneapolis-based company said the rapid test is the first exosome-based liquid biopsy to receive the breakthrough designation.
Bio-Techne gained a portfolio of four liquid biopsy tests through its 2018 purchase of Exosome Diagnostics, for which it paid $250 million upfront plus $325 million in milestone payments.
The deal was one of nine acquisitions Bio-Techne has made in the past three years as it expands beyond life sciences research. The company identifies oncology as an $800 million market opportunity.
Liquid biopsies, which detect cancer biomarkers in the blood, hold promise to advance the diagnosis and monitoring of cancers by giving physicians a quick, noninvasive method for analyzing genetic material. Major players entering the emerging field in recent years include Roche, through its $2.4 billion takeover of Foundation Medicine, and Qiagen, Siemens and Thermo Fisher Scientific.
The tests use a sample of the blood to identify mutations known to cause cancers from the ctDNA genes and can also detect two other types of biomarkers known as circulating tumor cells and exosomes.
The ExoDx prostate test is designed to gauge the aggressiveness of the cancer by analyzing three biomarkers found on exosomal RNA in urine. If the test shows a patient has low-grade cancer or benign disease, a full prostate biopsy may be avoided.
The test was launched in the United States in 2017 and has been available through a process that allows certified clinical laboratories to perform certain tests. Earlier this month, Bio-Techne announced it received a clinical laboratory permit from the New York Department of Health to provide the ExoDx prostate test in the state. The company noted that a large proportion of specimens for diagnostic tests originate from New York.
Bio-Techne’s other liquid biopsies acquired through its Exosome Diagnostics deal test for ALK, T790M and EGFR mutations in patients with non-small cell lung cancer.