The Incorporation of Clearance Represents an Important Advance in the Individualization of Biologic Dosing for IBD Patients
SAN DIEGO, CA / ACCESS Newswire / July 29, 2025 / Prometheus Laboratories Inc. ("Prometheus"), a leader in precision healthcare, announces the launch of PredictrPK® VDZ and PredictrPK UST, precision-guided dosing tests for adult patients with inflammatory bowel disease receiving vedolizumab (VDZ) and ustekinumab (UST) treatment. With this launch, Prometheus has now developed and commercialized precision-guided dosing tests for four of the most widely used biologics in inflammatory bowel disease (IBD)-adalimumab, infliximab, VDZ and UST. These new tests and the PredictrPK platform represent a significant advancement in precision medicine for immune-mediated diseases like IBD.
It's common for healthcare providers (HCPs) to observe significant variability in how patients respond to biologic therapies like VDZ and UST. While traditional therapeutic drug monitoring (TDM) provides useful information on drug levels and antidrug antibodies (ADAs), it doesn't fully explain why some patients fail to respond or lose response over time and does not provide insights on alternate dosing strategies.
PredictrPK tests address these gaps by adding clearance as a key output, delivering a more comprehensive view of each patient's individual pharmacokinetics. By incorporating drug clearance (i.e., how quickly drug is eliminated from the body) along with serum biologic concentrations and ADAs with pharmacokinetic modeling, Prometheus can provide HCPs with personalized alternative dosing guidance for their patients. This enables clinicians to optimize biologic exposure in support of improved clinical outcomes while avoiding ineffective treatment cycles that can contribute to healthcare cost inefficiencies.
At the recent Digestive Disease Week® 2025 Congress, the research and development team at Prometheus collaborated on several presentations exploring the impact of patient pharmacokinetics on treatment outcomes. Amongst the various factors studied, drug clearance was identified as being significantly associated with disease control in IBD. Notably, higher VDZ drug clearance (above the cutoff) was associated with 9-fold and 2-fold lower likelihood of endoscopic as well as clinical and biochemical remission, respectively, in Crohn's disease patients, reinforcing the clinical value of assessing drug clearance with PredictrPK VDZ.
"The expansion of the PredictrPK platform to include VDZ and UST is based on growing evidence that drug clearance in combination with concentrations is a key determinant of therapeutic response in IBD," said Patricia Vasquez, President of Prometheus. "Our internal analyses and recent collaborative studies from our research and development team have consistently shown that patients with higher clearance are less likely to achieve clinical and endoscopic remission. By integrating clearance into our predictive models, our accredited laboratory in San Diego can provide clinicians with a more comprehensive tool than traditional TDM to guide treatment decisions and improve patient outcomes."
About PredictrPK
PredictrPK are precision-guided dosing tests available for infliximab, adalimumab, vedolizumab, ustekinumab and available biosimilars that are intended for IBD patients to support improved outcomes. PredictrPK tests combine serology markers, patient-specific variables, current dosing and proprietary pharmacokinetic Bayesian forecast modeling to calculate drug clearance and help providers optimize dosing for individual IBD patients with predicted drug levels for both current and alternate doses and therapy intervals. Precise, individualized dosing can aid patients in achieving and retaining remission with biologics in less time.
About Prometheus Laboratories
Prometheus Laboratories has been a leading specialty clinical laboratory for 30 years. Our robust portfolio of precision medicine tests 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).
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Prometheus Laboratories Inc.
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SOURCE: Prometheus Laboratories
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