ASM Microbe 2023: The Changing Standard of Care for UTI Diagnosis

While scientists are constantly uncovering knowledge that can improve human health, that doesn’t translate to an immediate impact on medical practice. On average, it can take up to 17 years for the latest scientific evidence to reach patient care [1]. While closing this gap remains a challenge, in areas such as testing for urinary tract infections (UTIs), the industry’s standard of care is slowly evolving.

UTIs are common infections of the urinary system, typically seen in women, infants, and older adults [2]. In high-risk populations, these common infections can be dangerous and lead to potentially life-threatening complications.

During a panel at the American Society for Microbiology’s 2023 Meeting (ASM Microbe), Evan Diamond, Director of Business Development at Thermo Fisher Scientific, led panelists in a discussion on emerging trends in UTI diagnostics – and why complicated UTIs represent a perfect use-case for polymerase chain reaction (PCR) testing. The panel included Jami Elliot, Chief Executive Officer at Quantigen Biosciences, Dr. Manish Patel, MD, RPh, FACS, FPMRS, Chief Medical Officer & Medical Director at Vikor Scientific, and Rebecca Schorr, MPH, Manager of Health Economics & Outcomes Research & Reimbursement at Thermo Fisher Scientific.

Not all UTI patients are PCR candidates

With such a common infection, it’s important to understand which patients benefit the most from more advanced testing versus standard urine culture (SUC). According to Dr. Patel, the American Neurological Association guidelines indicate that PCR is not a replacement for the culture method in a young, healthy typical patient. “This is for what we consider complicated urinary tract infections. And what defines complicated? If they’re recurrent, if they’re persistent, if it’s in a male… These are all indicators that this person can become what’s called bacteremic and septic,” he explained.

In high-risk cases, PCR can help the care team treat the patient with a more effective treatment faster, which can help reduce hospitalizations and also promote better antibiotic stewardship.

Considerations for clinically relevant panels

Compared to other infectious diseases, testing for UTIs must be much broader because the way these infections present can vary substantially person-to-person. Schorr explained that because there are so many different patient populations impacted, the industry can’t rely on testing for a single pathogen.

Related to his work with Vikor Scientific, Dr. Patel described the importance of focusing on critical pathogens that drive hospitalizations and updating panels as new pathogens emerge. Designing the most clinically relevant panel is an active and ongoing process, he said.

Building a case for the clinical utility of PCR

A primary theme of the panel was how PCR tests are assessed for reimbursement, and what programs like Molecular Diagnostic Services (MolDX) are looking for when validating molecular diagnostics to establish coverage. Elliot shared his guidance for teams undergoing a technical assessment process: “I think it’s know the body you’re working with… It’s about understanding their particular requirements and not generalizing the process to all folks that you submit to.”

Standardized guidelines for the clinical validation of molecular diagnostic tests are still emerging. Schorr likened it to “building our bus as it’s moving” as researchers work to prove that PCR can detect pathogens faster and more accurately than other modalities. Schorr encouraged lab directors to consider the unmet needs for each patient population that the tests can meet, so they can best defend their clinical use.

To hear the full panel on the technical and policy considerations for UTI diagnostics, watch the conversation at ASM Microbe 2023 here on-demand.

For information on Thermo Fisher Scientific solutions that facilitate research in UTIs, please click here.

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