The test is said to apply a novel cancer marker to improve the accuracy and sensitivity of non-invasive bladder cancer testing
The FDA has granted breakthrough device status for URO17 bladder cancer recurrence test (Credit: Pixabay/Ewa Urban)
KDx Diagnostics has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its URO17 urine test for bladder cancer.
The URO17 bladder cancer recurrence test is said to apply a novel cancer marker to improve the accuracy and sensitivity of non-invasive bladder cancer testing.
According to the company, bladder cancer is the sixth most common cancer in the US and 81,000 people are newly diagnosed with the disease every year. Bladder cancer bears a relatively high recurrence rate.
KDx’s data demonstrated that URO17 test showed 100% sensitivity
KDx’s published data demonstrated that the URO17 test showed 100% sensitivity and 96% specificity in identifying recurrent bladder cancer from urine samples.
KDx Diagnostics co-founder and CEO Dr Nam Kim said: “The FDA’s designation of Breakthrough Device for our URO17 test validates our excitement about the potential of our test to improve bladder cancer treatment with attendant major impact in the marketplace for bladder cancer diagnostics.
“Breakthrough Device designation significantly enhances our ability to conduct the necessary clinical trials for approval and expedites the review process. We look forward to working closely with the FDA during this next exciting phase of product development.”
Established in 2017, KDx is engaged in the development of non-invasive cancer tests for early detection and therapy decisions in cancer.
The company is also planning to develop tests based on the same biomarker for other platforms and sample types, in addition to expanding its product line into other cancer diagnostic tests.
In November 2019, Vela Diagnostics secured FDA de novo designation to market its Sentosa SQ HIV-1 Genotyping Assay for the detection of HIV-1 genomic drug resistance mutations (DRMs).
Using the plasma of patients infected with HIV-1, the company’s in-vitro diagnostic test detects HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test.