Clinical Evolution of Diagnostic Testing with New Scientific Insights
SAN DIEGO, CA / ACCESS Newswire / December 8, 2025 / Prometheus Laboratories Inc. ("Prometheus"), a leader in precision-guided medicine, announces the launch of IBD Precis™, a next-generation serologic test designed to support the timely differential diagnosis, classification and clinical assessment of Inflammatory Bowel Disease (IBD). Leveraging proprietary biomarkers and a proprietary algorithm, IBD Precis helps distinguish patterns consistent or not consistent with IBD, differentiates Crohn's disease (CD) from ulcerative colitis (UC) and offers new insights into colonic involvement and complication risks, providing clinicians a powerful tool for patient stratification.
Diagnostic delays in IBD remain a significant challenge. A U.S. survey found that 64 percent of patients experience delays of one year or more from initial symptom recognition to diagnosis, and nearly half report delays exceeding two years, often after consulting multiple providers.1 These delays can lead to disease progression and an increased risk of complications.
To address these gaps, IBD Precis builds on the proven performance of Prometheus' IBD Serology 7 and IBD sgi® Diagnostic tests and introduces a new level of clinical insight through the integration of novel autoantibodies that associate with UC and colonic involvement, including anti-integrin αvβ6 (anti-αvβ6) and anti-proteinase 3 (anti-PR3). Anti-αvβ6 autoantibodies may be detectable up to a decade before a diagnosis of UC, rising to 52 percent at the time of diagnosis,2 while appearing in only three percent of healthy controls, underscoring the high specificity of this marker. Anti-PR3 antibodies address the lack of specificity of pANCA antibodies currently utilized in diagnostic testing today and have been associated with early and extensive colitis.3 These additions enhance the test's ability to identify and stratify disease and assess colonic involvement.
"We take pride in evolving our differentiated testing solutions as scientific advances are made in IBD diagnostics and care," stated Thierry Dervieux, PharmD, PhD, DABCC, Chief Scientific Officer at Prometheus Laboratories. "IBD Precis reflects our commitment to translating cutting-edge research into clinically meaningful tools that help providers deliver more personalized and proactive care."
The importance of early intervention is reinforced with findings from the PROFILE study, which demonstrated that initiation of biologic therapy early in Crohn's disease achieved endoscopic remission rates approaching 70 percent, compared to less than 50 percent in those treated with standard step-up protocols.4 Results were even more profound when comparing steroid-free and surgery-free remission. These results highlight the transformative potential of timely, targeted care.2
IBD Precis offers a quick, non-invasive and cost-effective solution to triage patients, guide referrals, clarify ambiguous imaging or pathology results, and inform surgical intervention strategies. Unlike stool-based testing, this serum-based test provides for standard phlebotomy in the patient workup for a more practical and patient-friendly approach to improving care pathways. This launch underscores Prometheus' ongoing dedication to delivering high-utility diagnostic solutions for clinicians treating patients with immune-mediated inflammatory diseases.
"Panels that incorporate novel markers could help with earlier identification of IBD, which is critical to improving long-term outcomes. The identification of some of these markers prior to diagnosis also opens the door for additional studies on disease prediction and prevention and the elucidation of the mechanisms involved with disease development," said Dr. Jean-Frederic Colombel, MD, Director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at the Icahn School of Medicine at Mount Sinai. "Additionally, IBD is a highly heterogeneous disease, and understanding individual patient profiles is essential for guiding personalized care strategies tailored to individual patient risks."
References:
Gallinger Z et al. Inflammatory Bowel Diseases. 2019 Feb; 25(S1):S14-S15
Livanos AE et al. Gastroenterology. 2023 Apr;164(4):619-629.
Noor NM et al. Lancet Gastroenterol Hepatol. 2024 May;9(5):415-427.
Dr. Colombel is a paid consultant and scientific advisor for Prometheus Laboratories.
About IBD Precis
IBD Precis is a next-generation algorithmic serum-based test developed to aid in the differential diagnosis, patient stratification and forecasting of disease progression in Inflammatory Bowel Disease (IBD). An evolution of the established IBD sgi Diagnostic platform, this test is a significant advancement in IBD diagnostics. IBD Precis tests add two novel UC-associated antibodies, anti-ανβ6 and PR3, to well established proprietary serologies.
About Prometheus Laboratories
Prometheus Laboratories has been a leading specialty clinical laboratory for 30 years. Our robust portfolio of testing improves the healthcare journey for individuals with immune-mediated and gastrointestinal diseases by empowering providers to diagnose, treat and help get their patients into remission faster with precision-guided care. For more information, visit the Prometheus website and follow us on LinkedIn or X (formerly Twitter).
Media Contact
Chrystal Johnson
Sr. Marketing & Events Specialist
Prometheus Laboratories Inc.
marketing@prometheuslabs.com
SOURCE: Prometheus Laboratories
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