EarlyTect BCD test : Promis Diagnostics gets FDA breakthrough designation
Promis Diagnostics has secured breakthrough device designation for its non-invasive EarlyTect BCD test from the US Food and Drug Administration (FDA) as a urine-based diagnosis of bladder cancer from hematuria patients. Hematuria is considered a frequent indicator of bladder cancer. The EarlyTect BCD test is designed to qualitatively identify PENK methylation, a single epigenetic biomarker […]