KDx has selected Acupath Laboratories to process urine specimens for a formal FDA trial that kicked off in Q3. First offered in July 2019 as an LDT (Laboratory Developed Test), Acupath was the first lab in the U.S. to offer URO17™, a urinary biomarker that improves on and adds value to traditional non-invasive diagnostic screening tests.
Bladder cancer is the 6th most common cancer in the U.S., with 81,000 new cancer cases annually, and a 75% recurrence rate. One of the most common and inexpensive screening tests, urine cytology, is largely ineffective and pathologically subjective, with limited sensitivity and specificity.
The FDA trial currently underway will evaluate URO17™ in conjunction with urine cytology and UroVysion™ FISH (Abbott Molecular). Several prominent LUGPA (Large Urology Group Practice Association) practices from across the US are participating as trial sites.
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"Since launching in July 2019, our clients and patients have benefitted from the clinical information provided by URO17™, which can serve as a valuable risk stratification tool, properly ruling in or out additional diagnostic tests," said John Cucci, Acupath's Chief Sales & Strategy Officer. "We are excited about being chosen by KDx for the FDA trial, which possesses significant potential to addresses the deficiencies of current diagnostic tests."
"We excited that a patient enrollment for our clinical study has initiated and that the Acupath is our partner in this endeavor. Following up on our recent Breakthrough Device designation by the FDA and CE marking for URO17™ test in Europe, we are moving ahead to obtain FDA clearance for this important test," said Nam W. Kim, Ph.D., CEO of KDx.