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 that is related to bladder cancer in the urine DNA of patients suffering from Hematuria.

The methylation process of PENK is found to occur often in the urine DNA of bladder cancer patients and rarely or not at all in hematuria patients without the cancer.

Breakthrough device designation from the FDA speeds up the review of cutting-edge technologies that could enhance the lives of those who suffer from life-threatening or irreparably debilitating ailments or diseases.

Sungwhan An — Promis Diagnostics CEO 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. EarlyTect BCD would provide a meaningful improvement in non-invasive diagnostics addressing unmet needs of catching primary cancer early in the initial diagnosis. Consequently, it will improve patient outcomes.”