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.
“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 presence of PENK methylation is a common occurrence in the urine DNA of all individuals diagnosed with bladder cancers, whereas it is rarely or not found at all in hematuria patients who are not suffering from the disease.
The designation will enable the availability of EarlyTect BCD as a new diagnostic option for individuals who are suspected to have bladder cancer.
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.”
The company offers non-invasive colorectal, bladder, and lung cancer diagnostic tests. It also has expertise in discovering DNA methylation biomarkers besides developing body fluidic-based methods for the detection of cancer.