Promis Diagnostics has received breakthrough device designation from the US Food and Drug Administration (FDA) for its EarlyTect BCD test.
The test is approved for a non-invasive, urine-based diagnosis of bladder cancer from haematuria patients.
EarlyTect BCD test will help qualitatively identify PENK methylation, a single epigenetic biomarker linked with bladder cancer in the urine DNA from haematuria patients.
Promis Diagnostics CEO Dr Sungwhan An said: “We are very excited about this FDA’s Breakthrough Device Designation grant to the EarlyTect BCD. It is a testament to our relentless commitment to developing an effective diagnostic test.
