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. "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. In a statement, Bio-techne’s chief executive, John O’Connor, said: “Through our innovative technology, we can now detect genetic changes in cancerous cells that would otherwise be difficult to detect.”
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. In a statement, Bio-techne’s chief executive, John O’Connor, said: “Through our innovative technology, we can now detect genetic changes in cancerous cells that would otherwise be difficult to detect.”