Bio-Techne’s urine test, designed to track down the exosomes and genomic markers released from prostate cancer cells, has received a breakthrough device designation from the FDA for ruling out unnecessary tissue biopsies.
The company describes its ExoDx Prostate IntelliScore test as the first liquid biopsy to receive breakthrough status for targeting exosomes, which are the small capsules released by cells carrying molecular cargo related to cell waste or communication and also bear RNA signatures of their home cell.
The test aims to spare patients an unneeded tissue biopsy following the results of a prostate-specific antigen blood test, or PSA reading—which can give false positive results or mistake relatively small, benign tumors for something more, leading to overdiagnosis and overtreatment, according to the National Cancer Institute. And biopsies alone can have serious side effects, including infection risks, diminished sexual function, incontinence, pain and hospitalization.
Bio-Techne, which also manufactures proteins for biomedical research, acquired the test nearly one year ago through a $575 million deal for Exosome Diagnostics, including $250 million upfront and $325 million in milestone payments.
That deal marked Bio-Techne’s 14th acquisition in five years, including its 2016 purchase of Advanced Cell Diagnostics as its first foray into genomics.
Since its launch, the company’s exosome test has been made available in every state—most recently with new clinical laboratory permits in New York, to serve as its 50th—and has been processed more than 25,000 times.
And in January, the National Comprehensive Cancer Network included the test in its clinical guidelines for the early detection of prostate cancer, recommending its use before a patient’s first prostate biopsy or after a negative biopsy.
"When we acquired ExosomeDx we knew it could be a platform that could transform the rapidly growing field of liquid biopsy," Bio-Techne President and CEO Chuck Kummeth said at the time.
"This is the first diagnostic test of many using both urine- and blood-derived exosomes that we will seek approval for over the coming years,” Kummeth said. “Our exosome-driven diagnostics platform is unique in the liquid biopsy field and is positioned to become true standard-of-care for diagnosing, treating and monitoring cancers as well as other diseases.”