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Pathnostics Announces Publication in Research and Reports in Urology of its Interim Analysis for a Prospective Observational Study Evaluating Guidance® UTI in Patients with Complicated Urinary Tract Infections

IRVINE, Calif., May 2, 2023 – Pathnostics, a leading precision diagnostic testing and development company, today announced publication of data from the Company’s interim analysis for a prospective observational study evaluating Guidance® UTI in patients with complicated urinary tract infections (cUTIs) in the peer-reviewed journal Research and Reports in Urology.

Guidance® UTI is Pathnostics’ advanced diagnostic test for the rapid identification and precise treatment of complicated, recurrent and persistent urinary tract infections (UTIs) – and the only UTI diagnostic to combine PCR and Pooled Antibiotic Susceptibility Testing (P-AST­TM), which better address polymicrobial infections where bacterial interactions can impact antibiotic resistance.

UTIs, the most common infections in the United States, account for 10.5 million physician office visits and three million emergency department visits annually, representing a major healthcare burden.[1],[2]  In many cases, particularly cUTIs, patients require antimicrobials to treat the infection. When an individual has one or more risk factors that predispose to higher treatment failure and poor outcomes, such as persistence of UTI, increasing severity, or occurrence of complications such as urosepsis, recurrence, and perinephric abscess, the case is considered a cUTI. [3],[4],[5]

“This peer-reviewed publication of data is an important validation of the precision diagnostics delivered through Guidance® UTI to improve the quality of patient care. The findings strengthen the benefits of increased sensitivity, accelerated results for patients and healthcare providers,” said Mohit Mathur, MD, Ph.D., Chief Medical Officer at Pathnostics. “While this is an interim analysis for an ongoing study, we’re pleased with the significance of the results and hope to forge a new standard of care for patients who suffer from complicated UTIs.”

The prospective study compared patients who were treated with antibiotics after being diagnosed through Guidance® UTI testing versus patients who had symptoms but were not treated using antibiotics. The data demonstrate that patients treated with antibiotics by providers who used Guidance® UTI test results had improved outcomes over those who did not receive antibiotics.

Analysis Highlights:

  • Patients with cUTIs treated based on the M-PCR/P-ASTTM diagnostic test had significantly improved symptom reduction and clinical cure rates compared to untreated patients among those with non-E. coli or polymicrobial infections.
  • Of 264 patients with suspected cUTI, 146 (55.4%) had exclusively non-E. coli infections (115 treated and 31 untreated) and 190 (72%) has polymicrobial infections (162 treated and 28 untreated).
  • Treated patients exhibited greater symptom reduction compared to untreated ones on day 14 for those with exclusively non-E. coli organisms (3.18 vs. 1.64, p=0.006) and polymicrobial infections (3.52 vs. 1.41, p=0.002), respectively.
  • Higher percentages of treated patients than of untreated patients achieved clinical cure for polymicrobial infections on day 14 (58.7% vs. 36.4%, p=0.049).

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[1] Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nature reviews Microbiology. 2015;13(5):269-284. doi:10.1038/nrmicro3432
[2] Simmering JE, Tang F, Cavanaugh JE, Polgreen LA, Polgreen PM. The Increase in Hospitalizations for Urinary Tract Infections and the Associated Costs in the United States, 1998-2011. Open Forum Infect Dis. 2017;4(1):ofw281. doi:10.1093/ofid/ofw281
[3] Wagenlehner FME, Johansen TEB, Cai T, Koves B, Kranz J, Pilatz A, et al. Epidemiology, definition and treatment of complicated urinary tract infections. Nat Rev Urol. 2020;17(10):586-600. doi:10.1038/s41585-020-0362-4
[4] A. S, Leslie SW. Complicated urinary tract infections. StatPearls [Internet]. Published online January 1, 2022.
[5] Gupta K, Hooton TM, Naber KG, Wullt B, Colgan R, Miller LG, et al. International Clinical Practice Guidelines for the Treatment of Acute Uncomplicated Cystitis and Pyelonephritis in Women: A 2010 Update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52(5):e103-e120. doi:10.1093/cid/ciq257

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