White paper from Pathnostics-convened roundtable identifies diagnostic obsolescence, wrong-antibiotic prescribing, and unmeasured patient consequences as primary drivers of the UTI crisis

IRVINE, Calif., May 5, 2026 /PRNewswire/ -- Pathnostics, a clinical diagnostics company specializing in urinary tract infection testing, today published findings from a structured multi-stakeholder roundtable examining the systemic burden of UTI management in the United States. The resulting white paper, "The UTI Crisis: Hidden in Plain Sight," presents consensus findings from a panel of experts spanning health policy, clinical microbiology, urology, and patient advocacy, and concludes that current UTI management represents a solvable systemic failure that has been normalized across the healthcare system.

The panel – which included David Nash, MD, MPA, Professor of Health Policy at Thomas Jefferson University; Frank Cockerill, MD, Former CEO of Mayo Clinic Laboratories; Glenn Werneburg, MD, PhD, Physician-Scientist in Urology at Stony Brook University; Melissa Kramer, PhD, Founder of Live UTI Free; and Hannah Helgeson of Let's Talk UTI – reached consensus around four imperatives for change in how UTIs are diagnosed, treated, and measured.

The Crisis: Wrong Therapeutic Direction Drives Avoidable Harm
UTIs generate more than 13 million diagnosed cases¹ and an estimated $6 billion in direct healthcare costs annually in the United States². The panel found that much of this spending is avoidable waste driven by getting the initial diagnosis and treatment decision wrong. More than half (53.5%) of UTI-related Medicare costs arise from escalated care – emergency department visits, hospitalizations, and skilled nursing facility stays – that follows first-line treatment failure³.

The panel identified a twofold diagnostic failure at the root of the crisis: detection and direction. Standard urine culture, based on a threshold established in a 1950s obstetric study⁴, may miss up to 75% of relevant organisms present⁵ and returns indeterminate results in up to half of specimens⁶. But detection is only part of the problem. The real opportunity is in improving therapeutic direction. Conventional antibiotic susceptibility testing evaluates organisms in isolation, missing the polymicrobial interactions that characterize many real-world UTIs. Conventional antibiotic susceptibility testing evaluates organisms in isolation, missing the polymicrobial interactions that characterize many real-world UTIs. PCR-only molecular approaches that expand detection without validated phenotypic susceptibility data have introduced more organisms identified, but are no better – and potentially worse – with treatment direction.

Four Imperatives for Change
The white paper presents a Why Change framework organized around four imperatives: (1) the wrong antibiotic creates compounding harm; (2) the diagnostic standard is obsolete in both detection and direction; (3) patient consequences are unmeasured and beyond any price tag; and (4) the system is not designed to adapt, while unproven claims from some diagnostic companies compound the inertia.

Key Thoughts From the UTI Crisis Roundtable Expert Participants:
"Every system is perfectly designed to achieve exactly the results it gets," said David Nash, MD, MPA. "The current standard of care in UTI management is producing exactly the downstream harm – the sepsis, the hospitalizations, the resistance – that its design predicts."

"We're basing our approach towards UTI on circa 1950 criteria developed for an obstetric population," said Frank Cockerill, MD. "It's an embarrassment from the diagnostic perspective. UTI is the last frontier of infectious disease diagnostics."

"Many of these patients over time are getting to the point where there are no good antibiotic choices left," said Glenn Werneburg, MD, PhD. "The collateral damage associated with the time window between when a patient gets symptoms and when they can get appropriately treated is substantial."

"The one true metric should be long-term patient outcomes," said Melissa Kramer, PhD. "If you start there and work backwards, every decision you make along the way is defined by that."

A Call for a New Diagnostic Standard
The panel emphasized the need to get to the right clinical direction the first time and called for a number of systemic improvements to include rethinking the measures for governing UTI performance, improving the diagnostic standard to include more focus on evidence based direction and better leverage of available diagnostic tools, as well as better engaging patients in their care providing them more agency in managing their condition. As such the white paper calls for the creation of standard outcome measurement frameworks for UTI management, including patient-reported outcomes, recurrence rates, and antibiotic appropriateness metrics.

The full white paper is available at pathnostics.com/uti-crisis/

About Pathnostics
Pathnostics is a clinical diagnostics company headquartered in Irvine, California. The company's flagship test, Guidance UTI with Pooled Antibiotic Susceptibility Testing (P-AST), combines multiplex PCR pathogen identification with phenotypic antibiotic susceptibility testing that evaluates the complete infection, including polymicrobial interactions. Pathnostics' evidence base includes 30+ peer-reviewed publications and 7 studies cited in the most recent AUA guidelines for recurrent UTI. For more information, visit pathnostics.com.

MEDIA CONTACT

Mohit Mathur MD, PhD
Chief Medical Officer, Pathnostics
(800) 493.4490
press@pathnostics.com

¹ Flores-Mireles, A.L.; Walker, J.N.; Caparon, M.; Hultgren, S.J. Urinary Tract Infections: Epidemiology, Mechanisms of Infection and Treatment Options. Nat. Rev. Microbiol. 2015, 13, 269–284, doi:10.1038/nrmicro3432. Simmering, J.E.; Tang, F.; Cavanaugh, J.E.; Polgreen, L.A.; Polgreen, P.M. The Increase in Hospitalizations for Urinary Tract Infections and the Associated Costs in the United States, 1998–2011. Open Forum Infect. Dis. 2017, 4, ofw281, doi:10.1093/ofid/ofw281.
² Carreno, J.J.; Tam, I.M.; Meyers, J.L.; Esterberg, E.; Candrilli, S.D.; Lodise, T.P. Longitudinal, Nationwide, Cohort Study to Assess Incidence, Outcomes, and Costs Associated With Complicated Urinary Tract Infection. Open Forum Infect. Dis. 2019, 6, ofz446, doi:10.1093/ofid/ofz446. 
³ Carreno, J.J.; Tam, I.M.; Meyers, J.L.; Esterberg, E.; Candrilli, S.D.; Lodise, T.P. Longitudinal, Nationwide, Cohort Study to Assess Incidence, Outcomes, and Costs Associated With Complicated Urinary Tract Infection. Open Forum Infect. Dis. 2019, 6, ofz446, doi:10.1093/ofid/ofz446.
⁴ Kass, E.H. Asymptomatic Infections of the Urinary Tract. Trans. Assoc. Am. Physicians 1956, 69, 56–64. Hilt, E.E.; Parnell, L.K.S.; Wang, D.; Stapleton, A.E.; Lukacz, E.S. Microbial Threshold Guidelines for UTI Diagnosis: A Scoping Systematic Review. Pathol. Lab. Med. Int. 2023, 15, 43–63, doi:10.2147/PLMI.S409488.
⁵ Festa, R.A.; Luke, N.; Mathur, M.; Parnell, L.; Wang, D.; Zhao, X.; Magallon, J.; Remedios-Chan, M.; Nguyen, J.; Cho, T.; Baunoch, D. A Test Combining Multiplex-PCR With Pooled Antibiotic Susceptibility Testing Has High Correlation With Expanded Urine Culture for Detection of Live Bacteria in Urine Samples of Suspected UTI Patients. Diagn. Microbiol. Infect. Dis. 2023, 107, 116015, doi:10.1016/j.diagmicrobio.2023.116015.
⁶ Hansen, M.A.; Valentine-King, M.; Zoorob, R.; Schlueter, M.; Matas, J.L.; Willis, S.E.; Danek, L.C.K.; Muldrew, K.L.; Zare, M.; Hudson, F.; et al. Prevalence and Predictors of Urine Culture Contamination in Primary Care: A Cross-Sectional Study. Int. J. Nurs. Stud. 2022, 134, 104325, doi:10.1016/j.ijnurstu.2022.104325. Whelan, P.S.; Nelson, A.; Kim, C.J.; Tabib, C.; Preminger, G.M.; Turner, N.A.; Lipkin, M.; Advani, S.D. Investigating Risk Factors for Urine Culture Contamination in Outpatient Clinics: A New Avenue for Diagnostic Stewardship. Antimicrob. Steward. Healthc. Epidemiol. 2022, 2, e29, doi:10.1017/ash.2021.260. Moreland, R.B.; Brubaker, L.; Wolfe, A.J. Polymicrobial Urine Cultures: Reconciling Contamination With the Urobiome While Recognizing the Pathogens. Front. Cell. Infect. Microbiol. 2025, 15, 1562687, doi:10.3389/fcimb.2025.1562687.

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