NEW YORK – Pathnostics announced on Wednesday that its Guidance UTI test has received approval from the New York State Department of Health.
The molecular test was authorized through the department's Clinical Laboratory Evaluation Program, Pathnostics noted in a statement. The test uses PCR to identify 27 individual organisms and three bacterial groups, as well as 32 resistance genes and six classes of antibiotics. The assay also uses Pathnostics' pooled antibiotic susceptibility testing technology P-AST to account for bacterial interactions that occur in polymicrobial infections that can affect antibiotic resistance, according to the company's website.
The test returns results in less than one day after sample receipt, Pathnostics added.
"This approval marks another step forward in our mission to make Guidance UTI the new standard of care for diagnosing and treating complicated, recurrent, or high-risk UTIs," Pathnostics CSO David Baunoch said in a statement. "For patients suffering from these types of cases, our test is a game-changer in enabling them to receive the most effective treatment plan for their situation as quickly as possible."