Miraca Life Sciences, an independent anatomic pathology lab based in Irving, Texas, is expanding into clinical pathology testing for patients with inflammatory bowel disease (IBD).
Miraca’s new InformTx therapeutic drug monitoring (TDM) service is based on technology and raw materials licensed from the French firm Theradiag, which has been offering TDM assays in Europe for years under the name LISA TRACKER.
InformTx testing assesses drug and anti-drug antibody blood levels for the biologic drugs infliximab (Remicade), adalimumab (Humira), certolizumab (Cimzia), and vedolizumab (Entyvio), mainly addressing IBDs such as Crohn’s disease and ulcerative colitis.
InformTx makes monitoring for certolizumab and vedolizumab available in the U.S. market for the first time, with no other U.S. medical lab offering this full set of four drug monitoring tests.
Theradiag estimates that more than 330,000 IBD patients in the U.S. are treated with biologic drugs — twice as many as in Europe. Theradiag will receive royalties on Miraca Life Sciences’ sales in the U.S.
“Miraca Life Sciences’ launch of our first four tests in the USA is a major milestone in our geographical expansion strategy and represents a source of large potential sales in the years to come,” said Theradiag CEO Michel Finance in a press release. “Its expertise and knowledge of the U.S. market make it the ideal partner to develop our LISA TRACKER range in the United States. The partnership enables us to make our biotherapy monitoring tests available to U.S. clinicians, helping them to optimize biotherapy treatments.”
Miraca Life Sciences’ laboratory in Phoenix, Arizona has been certified by CLIA and accredited by the College of American Pathologists. InformTx testing has been ramping up since May 2, beginning with a handful of selected physician practices, and the service is now available to all gastroenterologists in the U.S.
The enzyme-linked immunosorbent assay (ELISA) technology provides clinicians with quantitative test results, historical test result data, and guidance from current medical literature published in peer-reviewed scientific journals. InformTx testing requires samples of five to seven milliliters of peripheral blood drawn in a serum separator tube, and test results are returned within five days.
Miraca noted that factors potentially influencing individual patient response to IBD therapy using the four assay targeted biologic drugs may include variables such as systemic inflammation, other drug therapies, pharmacogenetic factors, disease phenotype, body mass, immunogenicity, immunomodulators, and the presence of anti-drug antibodies.
The company said that patients can be sub-categorized into four distinct types: “responders, initial responders, partial responders, and non-responders.” InformTx testing enables clinical management of all these patient types across the four biologic drugs used to treat IBD.
“Miraca Life Sciences has designed InformTx for today’s busy gastroenterologists to help them with the challenging task of optimizing treatment of patients on biologics via easy-to-interpret results and clear, actionable guidance,” said Dr. Frank Basile, president and CEO of Miraca Life Sciences, in a press release. “Through this clinical TDM testing, we offer new services to our clients and to the entire [gastrointestinal] field in the United States.”
Miraca Life Sciences is a subsidiary of Miraca Holdings, Japan’s largest clinical diagnostics and laboratory testing service provider. For more information, visit http://www.MiracaLifeSciences.com. For more information about InformTx, visit http://www.InformTx.com or call 1-844-305-2166.