Promis Diagnostics announced that the FDA has granted Breakthrough Device Designation to EarlyTect BCD as a non-invasive, urine-based diagnostic of bladder cancer in patients with hematuria.

In the United States, bladder cancer is the 6th most common cancer and the tenth leading cause of cancer death in 2023. The most common sign of bladder cancer is hematuria. However, about 10% of visible hematuria patients and only 2% to 5% with microscopic hematuria are diagnosed with bladder cancer.

The EarlyTect BCD test is intended for qualitatively detecting a single epigenetic biomarker, PENK methylation, associated with bladder cancer in the urine DNA from patients with hematuria. Methylation of PENK is known to present highly frequently in the urine DNA of all patients with bladder cancers, while rarely or not at all in hematuria patients without the disease.

“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,” says Promis Diagnostics CEO Sungwhan An, PhD. “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.”

Breakthrough Device Designation expedites the review of innovative technologies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions. To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment, and review while maintaining regulatory standards for pre-market approval. 

“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,” says Justin Lee, Promis Diagnostics head of business strategy and operations.