News & Events

February 22, 2022

Prometheus Laboratories Announces the Launch of PredictrPK® IFX, A Revolutionary Test Enabling Precision-Guided Dosing for Inflammatory Bowel Disease

SAN DIEGO, Feb. 17, 2022 /PRNewswire/ -- Prometheus Laboratories Inc. ("Prometheus"), a leader of precision healthcare, announced today the launch of PredictrPK IFX, a test that aids healthcare providers with biologic dose optimization through individualized pharmacokinetic modeling. The value of adaptive dosing has been demonstrated in recent clinical studies, and PredictrPK brings this advancement into routine clinical practice for the treatment of inflammatory bowel disease (IBD).

"PredictrPK is a revolutionary test that supports precision-guided dosing of biologics. I am very excited about incorporating the test into our IBD patient care protocols. By estimating a patient's future drug trough level, PredictrPK offers an opportunity for earlier adjustments to treatment strategies including dose escalation, dose de-escalation, changing the infusion interval, or deciding when a switch in therapy is needed," said Donald Lum, MD, FACG, Medical Director of Inflammatory Bowel Disease at The Oregon Clinic Gastroenterology East.

"In IBD, the approach to treat a patient must be tailored to the individual. Precise dosing and optimization improve therapeutic outcomes. In our early clinical trials in precision-guided dosing, individual clinical inputs were combined with week 14 trough levels and antidrug antibody status. Adaptive modeling recommended a dose or interval change in 96% of patients on IFX to maintain specified serum trough levels. Continuing with standard of care dosing was only recommended for 22% of patients. Our recent study data, demonstrates that IFX discontinuation and the development of antidrug antibodies can be reduced through early, proactive dose optimization," commented Marla Dubinsky, MD, Chief, Pediatric Gastroenterology and Nutrition, Icahn School of Medicine at Mount Sinai, and Co-Director of the Susan and Leonard Feinstein IBD Clinical Center at Mount Sinai Hospital in New York City. Dr. Dubinsky is an internationally recognized leader in pediatric gastroenterology and pioneer in personalized medicine for IBD patients. Dr. Dubinsky and colleagues recently published their findings from the first proactive infliximab optimization in Inflammatory Bowel Disease.

"PredictrPK IFX is the first in a family of PredictrPK tests. Validations are already underway to expand the claims of PredictrPK IFX for use earlier in patient management during the drug induction phase, along with development of PredictrPK tests for other IBD and inflammatory disease biologics," remarked Thierry Dervieux, PharmD., Ph.D., DABCC., Chief Scientific Officer at Prometheus.

Prometheus first introduced IBD biologic therapeutic drug monitoring with Anser® homogenous mobility shift assay (HMSA), a drug tolerant proprietary method which measures biologic drug concentrations as well as drug antibody levels for IFX, adalimumab, vedolizumab and ustekinumab. Anser has become widely adopted by US healthcare professionals, and has been utilized in numerous clinical studies that have advanced IBD patient management, with over 100 publications and abstracts from studies utilizing Anser tests. Notably, target IFX trough levels and their associated clinical outcomes have been well demonstrated in this foundation of literature.

PredictrPK builds upon the achievements of Anser, leveraging HMSA technology along with other markers and variables in a machine-learning algorithm to provide precision-guided dosing insights. Current TDM methods only provide historical point-in-time measurements of drug and antibody levels, whereas PredictrPK provides a forward-looking view to expeditiously guide achievement of target drug levels.

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About PredictrPKTM IFX
PredictrPK IFX combines serology markers, patient-specific variables, current dosing information, and a proprietary machine-learning algorithm to provide individualized actionable insights to optimize the dose and interval for inflammatory bowel disease (IBD) patients treated with infliximab (IFX) or IFX biosimiliars. PredictrPK IFX is currently validated for IBD steady-state maintenance patients treated (for ≥ 14 continuous weeks) with IFX therapy, and can be performed as early as 20 days after the last infusion. Test results include current infliximab, antibody, and albumin levels as well as estimated serum infliximab levels based on current dose and interval, and pharmacokinetic-guided doses and intervals.

About Prometheus Laboratories

Prometheus Laboratories is a specialty clinical laboratory which enables precision-guided care in Inflammatory Bowel Disease and other GI disorders. We discover, develop and commercialize testing services that help clinicians improve outcomes across the patient journey, from disease interception and stratification, to therapy selection, optimization and monitoring.

Dr. Dubinsky is a paid consultant for Prometheus Laboratories. SOURCE Prometheus Laboratories, Inc.