Prometheus Laboratories has collaborated with Celltrion USA to validate and expand the upper limit of quantitation for Anser IFX (infliximab) Therapeutic Drug Monitoring (TDM) testing for patients receiving ZYMFENTRA (infliximab-dyyb).

ZYMFENTRA is the only FDA-approved subcutaneous infliximab (IFX) formulation for maintenance treatment in adults with moderately to severely active Crohn's Disease (CD) and Ulcerative Colitis (UC) following intravenous infliximab.

When dosing is optimised, biologics such as IFX are highly effective for managing CD and UC. Anser IFX testing uses a drug-tolerant Homogeneous Mobility Shift Assay (HMSA) to provide clinicians treating these immune-mediated diseases with objective data on drug concentrations and the presence of anti-drug antibodies. This data can guide informed therapeutic decisions to support adequate drug exposure and persistent response, making it a valuable tool for optimising treatment strategies.

"As pioneers in therapeutic drug monitoring, we're pleased to extend the validation of our proprietary HMSA platform to subcutaneous infliximab dosing. This collaboration with Celltrion USA supports gastroenterologists in their efforts to better understand the exposure-response relationship to give patients an improved chance of sustaining disease control and response on this convenient form of at-home treatment for these debilitating diseases," said Patricia Vasquez, President, Prometheus.

Prometheus is the first specialty lab to validate TDM testing for both intravenous and subcutaneous infliximab, supporting the growing demand for at-home treatment options.

Thomas Nusbickel, Chief Commercial Officer, Celltrion USA, stated, "At Celltrion, having developed the world's first biosimilar monoclonal antibody, we remain committed to advance IBD care through a patient-centred approach, cutting-edge research and continuous innovation. IBD patients value the convenience of self-administering their maintenance treatments at home with ZYMFENTRA. This collaboration with Prometheus will support their providers in ensuring optimal drug concentrations and disease monitoring.”