Promis Diagnostics has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for its EarlyTect BCD test for the detection of bladder cancer in patients with hematuria.

EarlyTect BCD test is a non-invasive, urine-based diagnosis.

It is intended to qualitatively recognise PENK methylation, which is a single epigenetic biomarker related to bladder cancer in the urine DNA of patients having hematuria.

Bladder cancer is considered to be one of the most prevailing cancers in the US and its most common sign is hematuria.

Methylation of PENK is considered to be present very frequently in the urine DNA of all bladder cancer patients. However, it is rarely or not at all found in patients with hematuria without bladder cancer.

Promis Diagnostics CEO 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.

“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.”

The FDA’s breakthrough device designation helps accelerate the review of new technologies that can enhance the lives of patients having life-threatening or conditions that are irreversibly debilitating.

Promis Diagnostics business strategy and operations head Justin Lee said: “We look forward to working with the FDA to accelerate the approval process and to get EarlyTect BCD into the hands of patients and healthcare providers faster.”

Based in Irvine, California, Promis Diagnostics is a specialised laboratory, which has developed a technology called LTE-qMSP designed for the early detection of colorectal, bladder, and lung cancer by using methylated DNA as biomarkers.