Bio-Techne nets FDA breakthrough ticket in prostate cancer liquid biopsy

Bio-Technes 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.