Renflexis is Latest Addition to Therapeutic Drug Monitoring by Miraca Life Sciences

Miraca Life Sciences continues to expand in clinical pathology: its InformTx™ therapeutic drug monitoring (TDM) has begun the validation process for Renflexis™ (infliximab-abda), a biosimilar of Remicade® (infliximab). Testing will be commercially available in early November. Since launching the InformTx service in June 2016, Miraca Life Sciences has expanded its TDM testing to now eight biologic drugs that treat inflammatory bowel disease (IBD).

In the United States, InformTx is the only TDM (with anti-drug antibodies) available for Inflectra® (infliximab-dybb), Cimzia® (certolizumab pegol), Stelara® (ustekinumab), and Simponi® (golimumab). Miraca Life Sciences also continues to offer TDM for Remicade, Humira® (adalimumab), and Entyvio® (vedolizumab).

The InformTx report is unique in that it provides clinicians with quantitative test results, historical test result data, and guidance from the most up-to-date peer-reviewed scientific literature. Testing measures the level of the specified drug as well as patient-derived antibodies to the specified drug. Miraca Life Sciences uses laboratory-validated ELISA technology for InformTx TDM, and testing results are reported within five days.

“Since more drugs are becoming available to treat patients with IBD, Miraca Life Sciences will continue to seek therapeutic drug monitoring options for our clinician colleagues,” said Richard Lash, MD, Chief Medical Officer and Executive Vice President of Operations for Miraca Life Sciences. “Understanding patients’ drug and anti-drug antibody status is critical to guiding optimal care.”