Bio-Techne has been awarded breakthrough device designation by Exosome Diagnostics for its IntelliScore exosome test, which detects genomic markers from prostate cancer cells. The company said the urine test was the 50th liquid biopsy to win such approval. It spares patients having to rely on what the National Cancer Institute has said are less reliable tissue biopsies or prostate-specific antigen blood tests. Bio-Techne bought the test as part of its $250 million m acquisition of Exosome Diagnostics . The test is already available in the New York and the National Cancer Institute includes it in its prostate cancer guidelines.
Bio-Techne has been awarded breakthrough device designation by the Food and Drug Administration for its IntelliScore exosome test, which detects genomic markers from prostate cancer cells. The company said the urine test was the first liquid biopsy to win such approval. It spares patients having to rely on what the National Cancer Institute has said are less reliable tissue biopsies or prostate-specific antigen blood tests. Bio-Techne bought the test as part of its $575m acquisition of Exosome Diagnostics. The test is already available in the US and the National Comprehensive Cancer Network includes it in its prostate cancer guidelines.