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Prometheus Laboratories Announces a Major Milestone in Demonstrating Clinical Utility of Precision-Guided Dosing for Optimizing IBD Patient Care and Cost Savings

PredictrPK® IFX influenced changes in care in 58% of cases and confirmed current treatment approach in the remaining 42%.

SAN DIEGO, CA / ACCESSWIRE / December 21, 2023 / Prometheus Laboratories Inc. (“Prometheus”), a leader in precision healthcare announce data on the clinical utility of PredictrPK IFX, a precision-guided dosing test that aids in individualized infliximab (IFX) therapy optimization for inflammatory bowel disease (IBD) patients. “Real-World Impact of Infliximab Precision-Guided Dosing on Management of Patients With IBD" was published in The American Journal of Managed Care. The study demonstrated the utility of PredictrPK IFX in the clinical decision-making process to enable early and more individualized treatment decisions.

Among all participating providers who completed the prospective, multisite, clinical experience program known as EMPOWER (Effect on Decision-Making of Precision Optimization in Real-World Evidence Research), PredictrPK IFX was reported to be beneficial for informing treatment decisions for IBD patients. Key findings from the study included:

  1. PredictrPK helped guide treatment modifications: Test results influenced changes in treatment decisions in 58% of cases. Treatment modifications included adjustment of biologic dosing, switching biologic or therapy, other medication changes, imaging or testing.
  2. PredictrPK aided in confirming current treatment: Among the 42% of cases with no treatment modification, all but one had estimated IFX trough levels greater or equal to 5 μg/mL, in line with current American Gastroenterological Association guidelines for IFX patients in the maintenance phase of therapy and 83.6% had IFX levels greater or equal to 10 μg/mL in line with expert consensus. Patients with IFX concentrations less than 5 μg/mL were 3- and 7.3-times more likely to have active disease or discontinue IFX, respectively.
  3. Reduces unnecessary biologic costs: PredictrPK results allowed physicians to decrease dose or increase the interval of dosing in 32% of patients where dosing modifications were made, potentially avoiding unnecessary biologic drug use and yielding cost savings to the healthcare system.
  4. Precision-guided dosing provided greater value: All healthcare providers who completed the post-program survey indicated that PredictrPK IFX was beneficial for informing treatment decisions and added more value to their practice than traditional therapeutic drug monitoring.

“These findings represent a major advancement in IBD treatment and management,” David Ziring, MD, Associate Director of the Inflammatory Bowel Disease Pediatric Program at Cedars-Sinai Medical Center and a co-author of the study. “Patients with IBD require a personalized approach, as one size does not fit all. This data demonstrates that precision-guided dosing can fundamentally improve the long-term success of biologic treatment by assessing the individualized dosing needs of patients. It is imperative that payers recognize the immense value of this type of testing. Not only does it directly benefit our patients by ensuring they receive the right treatment - at the right dose and interval, but it also holds the potential to drive substantial cost savings and more efficient healthcare resource utilization.”

“The real-world implications of these findings are profound. Tailoring treatment plans to individual patient needs supports both the patient and healthcare resource utilization. This approach enables more effective and efficient biologic utilization, which in turn, can reduce the risks for adverse events including treatment failure, disease relapse, and avoidable hospitalizations and surgeries,” commented Andrew Shim, Vice President of Medical Affairs at Prometheus. “We are continuing with health economic and outcomes research to further validate the clinical and health economic benefits of precision-guided dosing of biologics in IBD.

About Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (IBD) is a group of chronic inflammatory diseases, including Crohn’s disease and ulcerative colitis, that impacts an estimated three million US patients. Anti-TNF biologics, including infliximab, are often first line therapies for patients with moderate to severe disease. Unfortunately, up to 50% of patients on biologic therapy do not achieve remission; and another 50% of initial responders to anti-TNF therapies lose response within one year, which is often attributable to inadequate drug exposure.


EMPOWER included a diverse group of thirty-seven gastroenterology practitioners from 19 states and Puerto Rico treating both pediatric and adult patients in academic and community settings. Participating providers were granted access to PredictrPK IFX, to be utilized in the IBD patients and scenarios of their choosing with the restriction that patients needed to be currently undergoing IFX maintenance therapy. A total of 275 patient scenarios were represented; PredictrPK results were shared with providers and their decision-making process was assessed through post-test questionnaires.

About PredictrPK® IFX

PredictrPK IFX is validated for adult and pediatric IBD patients receiving IFX or IFX biosimilars. Combining serology markers, patient- and disease-specific variables, current dosing, and a proprietary machine-learning algorithm, PredictrPK IFX provides individualized, actionable insights to support optimized dosing. PredictrPK also allows providers to quickly assess measured IFX and antibodies-to-IFX (ATI) via the drug-tolerant homogeneous mobility shift assay (HMSA) technology at the time of sample collection.

About Prometheus Laboratories

Prometheus Laboratories is a leading specialty clinical laboratory which improves the healthcare journey for individuals with immune-mediated and gastrointestinal diseases by empowering providers to diagnose, treat and get their patients into remission faster with precision-guided care.

For more information, visit and follow @Prometheuslab.