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New York State Approves Pathnostics’ Guidance® UTI Test

Approval Broadens Patient Access to Company’s Advanced Test Enabling Rapid and Precise Diagnosis of Complicated Urinary Tract Infections

Pathnostics, a leading precision diagnostic testing and development company, today announced that its advanced test for urinary tract infections (UTIs) has gained approval from the New York State Department of Health (NYSDOH). The approval broadens patient access to the company’s Guidance® UTI test, which enables rapid diagnosis and precise treatment of complicated, recurrent, and persistent UTIs.

Guidance® UTI received authorization through the NYSDOH Clinical Laboratory Evaluation Program, which is considered one of the most rigorous and comprehensive review processes for clinical laboratory testing in the United States. It is the only NYSDOH-approved advanced UTI test that engages advanced molecular technology for identification of organisms and resistance genes combined with pooled antibiotic susceptibility results.

To learn more about Pathnostics’ Guidance® UTI test, click here.

David Pauluzzi, CEO, Pathnostics, stated:
“We are thrilled that our Guidance® UTI test has been approved by an organization renowned for its expertise, high standards, and stringent process for validating clinical lab tests. Earning this approval is a testament to the Guidance® UTI test and its impact in addressing a complex health challenge.”

As many as 10 million UTI cases occur annually in the US and can lead to health and quality-of-life issues when not treated effectively. Guidance® UTI enables healthcare providers such as urologists and urogynecologists to rapidly diagnose and precisely treat patients with these complex cases. Key benefits of the Guidance® UTI test are that it:

  • delivers results less than a day after samples are received in the lab compared to standard urine culture testing, which can take up to five days to produce results
  • yields the highest level of diagnostic specificity and sensitivity versus standard testing, including identifying specific uropathogens even when multiple organisms are present
  • significantly reduces patient hospitalizations, emergency and urgent care visits, and empiric therapy rates, as demonstrated through multiple studies

David Baunoch, Chief Scientific Officer, 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. 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.”

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