SAN DIEGO, Oct. 18, 2023 /PRNewswire/ — ProciseDx Inc. announces that it has purchased two US patents in therapeutic drug monitoring (TDM) of biologic drugs to supplement its existing global patent portfolio. The two patents, US Patent No. 11,119,096 “Universal assay for determining the quantity of therapeutic monoclonal antibodies and their corresponding anti-drug antibodies in samples” and US Patent No. 11,085,931 “Universal assay for determining the quantity of TNF alpha inhibitory drugs and their corresponding anti -drug antibodies,” were purchased from W.Health LP.
“We believe these patents as well as our existing intellectual property forms a solid foundation for our path forward in expanding our reach in therapeutic drug monitoring of biological drugs,” said Larry Mimms, PhD, CEO of ProciseDx.
ProciseDx Inc. had recently announced that it has been granted de novo clearance by FDA for the therapeutic drug monitoring (TDM) tests for infliximab (Remicade® and biosimilars Inflectra® and Renflexis®) and adalimumab (Humira® and Amjevita®).
“Therapeutic drug monitoring of biologics is a useful tool in optimizing the care of patients with IBD and has become an accepted standard of care for IBD patients. Personalized dosing of biologics can improve outcomes,” said Adam Cheifetz, MD, Professor of Medicine and Director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center/Harvard Medical School.
“ProciseDx expects to launch infliximab and adalimumab assays at laboratories in the US later this year in collaboration with Chembio Diagnostics Inc. which is part of the family of US-based Biosynex-owned companies,” said Thierry Paper, Directeur Général Délégué (deputy CEO, Biosynex S.A. , Strasbourg, France)
Biosynex has 100% ownership in ProciseDx and also majority stake in French company Theradiag which has been pioneering the TDM market in Europe for more than 10 years. On September 29, 2023 the boards of Biosynex and Theradiag approved a merger of the two companies. The objective of Biosynex is now to reinforce its global leadership position on the TDM market through implementation of technological, regulatory, and commercial synergies among those two TDM expert entities.
ProciseDx received FDA clearance for the ProciseDx analyzer and first immunoassay for C-Reactive protein (CRP) in November, 2022. ProciseDx assays are CE-marked and have been marketed for TDM tests in Europe and Middle East since 2021 with on-site, 5-minute assays on the ProciseDx analyzer testing blood for CRP, infliximab, and adalimumab as well as an inflammatory bowel marker fecal calprotectin in stool.
About ProciseDx Inc.
ProciseDx is an in vitro diagnostics (IVD) company developing a broad portfolio of rapid diagnostic tests for the physician’s office. Founded by experienced IVD specialists with a track record of successfully launching innovative on site testing platforms, ProciseDx tests have a turn-around time of only 2-5 minutes and are easy, quantitative and accurate. ProciseDx tests use serum or finger prick blood sample or a stool sample and ProciseDx’s first menu is focused on GI physicians (gastroenterologists).
ProciseDx occupies 30,000 sq. ft. of laboratory, manufacturing and office space in San Diego, California. ProciseDx is ISO13485 certified.
For more information about ProciseDx, please visit us at www.procisedx.com.
Founded in 2005 and based in Illkirch-Graffenstaden in Alsace, a major player in public health with more than 225 employees, the French laboratory Biosynex designs, manufactures and distributes Rapid Diagnostic Tests (TDRs). In their professional version, they offer better medical care of patients thanks to the speed of their result and their simplicity of use. In their self-test version, they allow patients to self-monitor various pathologies thus ensuring better prevention and accelerating the demand for care. Biosynex is the leader in the TDR market in France and is the only player to fully control its value chain thanks to its technology platform, which can be used in a variety of applications and is adapted to different types of users such as laboratories, hospitals, doctors and the general public.
Larry Mimms, CEO