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Prometheus Laboratories Announces the Launch of PredictrPK® ADA, A Precision-Guided Dosing Test for Optimization of Adalimumab

PredictrPK ADA addresses the unmet need for individualized optimization of adalimumab (ADA) therapy in support of sustained clinical remission and drug persistence.

SAN DIEGO, CA / ACCESSWIRE / July 27, 2023 / Prometheus Laboratories Inc. ("Prometheus"), a leader in precision healthcare, announced the launch of PredictrPK ADA, a precision-guided dosing test for adult Crohn's disease (CD) patients receiving ADA treatment. With this launch, Prometheus has now developed and commercialized precision-guided dosing tests for two of the most utilized biologics in inflammatory bowel disease (IBD), ADA and infliximab. This testing platform represents a major breakthrough in precision medicine for immune-mediated diseases. PredictrPK tests address the wide interpatient variability in initial therapeutic response and support biologic persistence. They also guide cost-effective care, potentially mitigating unnecessary and expensive healthcare resource utilization.

PredictrPK tests support optimized treatment for individual patients and improved clinical outcomes by offering healthcare providers guidance on adjustment of biologic therapies based on a patient's unique pharmacokinetic and clearance profile. These insights can support a provider's decision to taper dosing once a patient is in remission, escalation of dosing when loss of response is suspected and other treatment modifications including therapeutic switching to achieve an adequate response. Tailoring anti-TNF dosing to a patient's unique pharmacokinetics aims to maximize therapeutic efficacy while minimizing disease flares and wasted drug costs that can drive healthcare inefficiency.

"The availability of individualized, actionable data empowers physicians to optimize treatment, enhance disease control, and improve outcomes," Bincy Abraham, MD, Fondren Distinguished Professor in Inflammatory Bowel Disease and IBD Specialist at Houston Methodist Weill-Cornell Department of Medicine. "Access to precision-guided dosing marks a monumental shift in patient care for IBD providers, removing the guesswork out of predicting drug levels and adjusting dosing as accurately as possible."

At the recent Digestive Disease Week® (DDW®) 2023 Congress, Prometheus collaborated on six presentations exploring the impact of patient pharmacokinetics on treatment outcomes. Amongst the various factors studied, drug clearance (i.e., how quickly drug is eliminated from the body) was identified, in two separate studies, as significantly associated with disease control in CD. Of note, ADA clearance below identified thresholds associated with a 4- to 5-fold increased likelihood of endoscopic remission (Wright et al) and accelerated ADA clearance was associated with a lack of CD disease control (McGovern et al). Both studies noted that these findings may help stratify patients likely to benefit from early dose optimization.

"As data showing the impact of clearance to inform biologic management is further studied and better understood, the decision to include calculated ADA clearance as a top-line result in PredictrPK ADA was clear." Thierry Dervieux, PharmD, PhD, DABCC, Chief Scientific Officer at Prometheus and co-investigator on the DDW studies. "For more than 20 years, Prometheus has advanced patient care with innovative testing services, driven not only by our understanding of the unmet needs of today, but by anticipating those of tomorrow. The combination of individualized ADA dosing guidance coupled with clearance available in PredictrPK ADA is representative of that history and signifies a remarkable leap forward in biologic management."

About PredictrPK® ADA

PredictrPK ADA is a precision-guided dosing test validated for adult CD patients receiving ADA or ADA biosimilars. Combining serology markers, disease-specific variables, current dosing, ADA clearance, and a proprietary machine-learning algorithm, PredictrPK ADA provides individualized, actionable insights to support optimized dosing of ADA with estimated ADA concentrations at alternative dosing regimens. PredictrPK ADA allows providers to quickly assess measured ADA and antibodies-to-ADA (ATA) via the drug-tolerant homogeneous mobility shift assay (HMSA) technology at the time of sample collection and includes calculated ADA clearance.

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 help get their patients into remission faster with precision-guided care.

For more information, visit and follow @Prometheuslab.