Urine test for prostate cancer receives breakthrough desigAugust 5, 2019
ExoDx Prostate IntelliScore, a urine test which can detect the exosomes and genomic markers released from prostate cancer cells, has received a breakthrough device designation from the USFDA.
The test is the first liquid biopsy to receive breakthrough status for targeting exosomes, Bio-Techne said. Exosomes are the small capsules released by cells carrying molecular cargo related to cell waste or communication. They also carry RNA signatures of their home cell.
The test will spare patients an avoidable tissue biopsy following the results of a prostate-specific antigen blood test. PSA often gives false positive results or mistakes relatively small, benign tumours leading to overdiagnosis and overtreatment, according to the National Cancer Institute.
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.
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, according to the company.