Arizona Tribune - Prometheus Laboratories Launches First Pre-Therapy Test to Predict Likelihood of Biologic Response

SAN DIEGO, CA / ACCESS Newswire / April 29, 2025 / Prometheus Laboratories Inc. ("Prometheus"), a leader in precision-guided medicine, announces the novel Responder TNF blood test is now commercially available. Respondr TNF is the first test to predict an inflammatory bowel disease (IBD) patient's likelihood to respond to infliximab, adalimumab and their biosimilars prior to therapy administration.

Biologic medications that suppress the body's natural response to tumor necrosis factor (TNF) are often first-line treatments for moderate to severe IBD. Anti-TNF drugs can be costly to patients and insurers since 40% of patients starting an anti-TNF are non-responders¹ and up to 50% of those who initially respond experience a secondary loss of response in the first year.² Since damage caused by uncontrolled disease can lead to costly interventions and impact quality of life, it is critical to select a treatment with a high likelihood of achieving disease control and to mitigate risk of non-response by identifying those that may benefit from more active therapeutic management.

Prior to the availability of Responder TNF, no laboratory test was available to help predict response before initiation of therapy. Now providers can use this serogenomic test to gain objective evidence to guide treatment decisions for patients before initiating the most widely prescribed biologics for IBD-infliximab, adalimumab and their biosimilars.

"Our validated technology analyzes a patient's unique pre-therapy clearance profile along with a specific genetic marker to predict the likelihood of a patient's response to anti-TNF biologic therapy before initiation," stated Prometheus Chief Scientific Officer Thierry Dervieux, PharmD, PhD. "Respondr TNF results support providers' therapy selection and management approaches. If an anti-TNF is selected, providers can consider the benefit of active therapeutic management utilizing precision-guided dosing, enabled by our PredictrPK^® tests, to optimize dosing and further improve the likelihood of achieving sustained remission for patients suffering from IBD."

A study co-authored by 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, published in Frontiers in Immunology,³ evaluated the combination effect on outcomes of accelerated pre-therapy clearance and genetic risks of IBD patients being considered for anti-TNF therapy. "We found that patients with accelerated clearance (>0.326 L/day) who were also genetic carriers of the HLA DQA1*05 risk allele were two-fold more likely to develop antibodies and each of these risk factors associated with incremental risk and lower likelihood of endoscopic remission," Dubinsky shared.

Providers can now integrate the unique test results into their clinical decision-making for patients with IBD being considered for biologic treatment. "My patients look to me for advice, and before Respondr TNF, we never had objective insights into how patients may respond to these first-line biologics," shared Audra Rouster, MD, Division Chief of Pediatrics Gastroenterology, West Virigina University Health Sciences. "In pediatric IBD care, biologic options are extremely limited, and we can use the data from Respondr to identify patients where response needs to be more closely monitored. This enables us to intervene quickly with dose optimization or treatment modifications. If a therapy switch is indicated, the information we get from Respondr and PredictrPK is invaluable for appeals for medications that have not yet received a pediatric indication."

The launch of Respondr TNF marks another step in Prometheus' commitment to advancing precision medicine through innovative diagnostics solutions. The company's continuum of proprietary tests supports providers with clinical decision-making tools through the entire IBD patient care journey, from diagnosis to achieving and maintaining long-term remission.

References

1. Aitken et al. IQVIA Institute for Human Data Science. Medicine Use and Spending in the U.S. A Review of 2017 and Outlook to 2022. April 2018.

2. Syed et al. Crohn's & Colitis 360. 2020;2:otaa050.

3. Spencer et al. Poor prognostic factors of pharmacokinetic origin predict outcomes in inflammatory bowel disease patients treated with anti-tumor necrosis factor-α. Frontiers in Immunology, 15. January 2024.

About Respondr TNF

Respondr TNF is a proprietary test that uses objective evidence to predict an individual patient's likelihood of response to infliximab, adalimumab or their biosimilars prior to initiation of therapy. This unique blood test uses two critical prognostic factors, pre-therapy clearance and genetics, to help guide therapeutic selection. Knowing an inflammatory bowel disease patient's likelihood of achieving and sustaining a therapeutic response to anti-TNF therapy, providers can help patients establish the most appropriate care plan and identify patients who may benefit from more active therapy management.

About PredictrPK

PredictrPK are precision dosing tests available for infliximab, adalimumab and their biosimilars that are intended for IBD patients to support improve outcomes. PredictrPK tests combine serology markers, patient-specific variables, current dosing and proprietary machine-learning algorithms to calculate drug clearance and help providers to 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 and doing so in less time.

About Prometheus Laboratories

Prometheus Laboratories has been a leader in IBD patient care solutions for 30 years. Our continuum of tests empowers providers to diagnose, treat and help get IBD patients into remission faster with precision-guided care. Our proprietary test portfolio can aid providers who treat IBD patients through the entire patient care journey - from diagnosis to achieving and maintaining long-term remission. For more information, visit the Prometheus website and follow us on LinkedIn or X (formerly Twitter).

Drs. Dubinsky and Rouster are paid consultants for Prometheus Laboratories.

Media Contact
Chrystal Johnson
Sr. Marketing & Events Specialist
Prometheus Laboratories Inc.
[email protected]

SOURCE: Prometheus Laboratories

View the original press release on ACCESS Newswire

A.Williams--AT