Pathnostics

Pathnostics is a United States clinical diagnostics company headquartered in Irvine, California, and established in 2011. It operates a CAP-accredited and CLIA-certified laboratory and describes its core capabilities as spanning infectious disease and cancer diagnostics, with a test menu that includes histopathology, cytology, and molecular testing across urology, women's health, and gastroenterology. Its stated mission is to pioneer a better future for physicians, patients, and the healthcare system by resolving diagnostic and therapeutic dilemmas. The company's flagship offering is Guidance® UTI with P-AST™, a precision diagnostic platform for complicated, recurrent, or persistent urinary tract infections. Guidance® UTI combines molecular detection of uropathogens and resistance genes with proprietary Pooled Antibiotic Susceptibility Testing (P-AST™), which evaluates how a panel of antibiotics performs against a patient's infection as a whole, including polymicrobial cases. Pathnostics positions this approach as a move beyond detection alone toward "direction" that supports better first-pass treatment decisions, and it markets the platform under the tagline "Right Treatment. First Time." Pathnostics frames the clinical and economic problem it addresses in stark terms: it cites more than $6 billion in direct healthcare costs annually tied to UTI treatment failure, states that 68% of patients receive an inappropriate antibiotic regimen, that 1 in 5 UTI cases experience treatment failure, and that 1 in 3 patients require retreatment. The company argues that most UTI treatment failure begins not with the antibiotic but with diagnostics that fail to give clinicians fast, accurate direction. Its Guidance® UTI materials claim results in less than one day from receipt at the lab, 95% sensitivity in organism identification (described as 43% more sensitive than culture), detection of 32 resistance genes across six antibiotic classes, and identification of specific pathogens even in polymicrobial infections, which it says occur in up to 52% of positive cases. Pathnostics serves healthcare providers including urologists, primary care physicians, gynecologists, gastroenterologists, and medical directors, across care settings such as post-acute care, immediate/urgent care, healthcare at home, urology clinics, and telemedicine. The company emphasizes evidence generation: it states that it has completed eight clinical studies involving more than 73,000 subjects for Guidance® UTI, with key findings published in fifteen peer-reviewed journals. It also maintains an executive management team, a Board of Directors, and a Scientific Advisory Board. Pathnostics is a private company and, per public records, is located in Irvine, United States.

Pathnostics was established in 2011 and built its business around clinical diagnostics, operating a CAP-accredited and CLIA-certified laboratory. From its headquarters in Irvine, California, the company developed capabilities in infectious disease and cancer diagnostics, assembling a test menu that spans histopathology, cytology, and molecular testing across urology, women's health, and gastroenterology. The company's defining development was the creation of its Guidance® UTI platform, which combines molecular detection with proprietary Pooled Antibiotic Susceptibility Testing (P-AST™). This platform became the company's flagship offering and the centerpiece of its clinical evidence program. According to the company, it has completed eight clinical studies involving more than 73,000 subjects for Guidance® UTI, with key findings published in fifteen peer-reviewed journals. Pathnostics has positioned its work against the persistent problem of urinary tract infection treatment failure. It cites more than $6 billion in direct healthcare costs annually, states that 68% of patients receive an inappropriate antibiotic regimen, that 1 in 5 UTI cases experience treatment failure, and that 1 in 3 patients require retreatment. The company's argument is that most UTI treatment failure begins not with the antibiotic but with diagnostics that fail to provide accurate direction quickly enough, and that its platform addresses this by delivering results in less than one day from receipt at the lab and by evaluating how antibiotics perform against the patient's infection as a whole. Over time, Pathnostics has expanded its commercial reach to a range of provider types — urologists, primary care physicians, gynecologists, gastroenterologists, and medical directors — and care settings including post-acute care, immediate/urgent care, healthcare at home, urology clinics, and telemedicine. The company also maintains an executive management team, a Board of Directors, and a Scientific Advisory Board, and describes itself as driven by continuous research, clinical evidence development, product implementation, and service delivery. It remains a private company headquartered in Irvine, California.

• 2011

  Pathnostics is established, building its business around clinical diagnostics.

• Pathnostics develops Guidance® UTI with P-AST™, combining molecular detection with proprietary Pooled Antibiotic Susceptibility Testing.

• The company reports completing eight clinical studies involving more than 73,000 subjects for Guidance® UTI, with key findings published in fifteen peer-reviewed journals.

A precision diagnostics company focused on infectious disease and cancer diagnostics, positioning its Guidance® UTI platform as a move beyond detection alone toward accurate, fast direction that supports better first-pass antibiotic decisions and antibiotic stewardship.

• Guidance® UTI with P-AST™

  A precision diagnostic platform for complicated, recurrent, or persistent UTIs that combines molecular detection of uropathogens and resistance genes with proprietary pooled phenotypic antibiotic susceptibility testing. Results in less than one day from receipt at the lab.

• Organism identification (PCR)

  Identifies commonly tested uropathogens, including fastidious bacteria and yeasts difficult to detect by culture; described as 95% sensitive and 43% more sensitive than culture.

• Resistance gene detection (PCR)

  Targeted PCR amplification detects 32 resistance genes across six antibiotic classes, including ampicillin, carbapenem, ESBL, methicillin, fluoroquinolone, and vancomycin resistance.

• Pooled Antibiotic Susceptibility Testing (P-AST™)

  Evaluates how 20 antibiotics perform against the patient's infection as a whole, accounting for bacterial interactions in polymicrobial cases.

1. 1Pathnostics — Right Treatment. First Time.pathnostics.com
2. 2About Us — Pathnosticspathnostics.com
3. 3Privacy Policy — Pathnosticspathnostics.com
4. 4Guidance® UTI with P-AST™ — Pathnosticspathnostics.com
5. 5Pathnostics (United States) — Wikidatawikidata.org