Expect to Transform Biologics Therapeutic Drug Monitoring in the US through on-site testing

Breakthrough ProciseDx diagnostic technology enables quantitative f5-minute tests forherapeutic Drug Monitoring

San Diego, CA- ProciseDx Inc. announces that it has been granted de novo FDA clearance for the therapeutic drug monitoring (TDM) tests for adalimumab (Humira® and biosimilar Amgevita®) and infliximab (Remicade® and biosimilars Inflectra® and Renflexis®).

These assays, called Procise ADL and Procise IFX, are used to quantify adalimumab (ADL) and infliximab (IFX) in patients with inflammatory bowel diseases (IBD) who are taking these drugs. The tests are intended for use in hospital and other moderate complexity clinical laboratories. 4.3 million people in the US are diagnosed with IBD (Crohn’s disease and ulcerative colitis) and up to 15% aretreated with IFX or ADL.

ProciseDx expects to commercialize these first FDA-cleared infliximab and adalimumab drug monitoring tests in Q4 2023. The tests can be performed using serum and take only 5 minutes to obtain a quantitative result.

Biologics like Humira and Remicade are the biggest drivers of expenses in IBD treatment according to a cost study by Crohn’s and Colitis Foundation. Drug cost for IBD patients taking biologics are $20K - $60K annually.

“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. “These first FDA cleared tests for infliximab and adalimumab can improve access to TDM for patients by enabling immediate testing.”

Niels Vande Casteele, PharmD, PhD, Associate Professor of Medicine at the University of California, San Diego stated, “Patients with inflammatory bowel disease (IBD) metabolize and respond to anti-tumor necrosis factor alpha biologics differently. Measuring blood drug concentrations with an FDA-approved rapid assay at site of care presents a new opportunity to better understand sources of variability in drug pharmacokinetics and pharmacodynamics between patients. Performing TDM may help physicians understand why some patients respond or lose response to the treatment, which allows for a more personalized treatment.”

ProciseDx and Dr. Vande Casteele will present the results of their benefit-risk analysis research using ProciseDx for TDM vs empiric dose escalation in patients with secondary loss of response to infliximab at the American College of Gastroenterology meeting in October 2023 in Vancouver. Dr. Cheifetz and Dr. Vande Casteele have served as consultants for ProciseDx.

The Procise TDM assays are based on time-resolved fluorescence (Förster) resonance energy transfer immunoassays for the determination of drug levels in patients undergoing infliximab and adalimumab therapy, using the patented ProciseDx Analyzer and Lumiphore® chemistry. The ProciseDx technology enables on-site TDM testing in moderate complexity laboratories in hospitals and clinical laboratories.

“Currently, results for drug concentrations for infliximab and adalimumab take days and require shipment to expensive third party laboratories,” said Larry Mimms, PhD, CEO of ProciseDx. “The ProciseDx platform will change that, with a simple workflow producing a reliable quantitative measurement in 5 minutes or less. ProciseDx enables physicians and hospital laboratorians to take control of biologics TDM through on-site testing.”

“ProciseDx expects to launch infliximab and adalimumab tests at laboratoriesin 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). “I want to thank the ProciseDx team that is bringing this innovation to IBD patients in the US. Biosynex has made TDM a strategic focus.”

Biosynex has 100% ownership in ProciseDx and also a majority stake in the French company, Theradiag, which has been pioneering the TDM market in Europe for more than 10 years. 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 its 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.

About Biosynex

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 (RDTs). The professional version of these tests offers better patient medical care thanks to their rapid results and simplicity of use. In their self-test version, these tests allow patients to self-monitor various pathologies enhancing prevention and accelerating the demand for care. Biosynex is the leader in the RDT market in France and is the only player to fully control its value chain due 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.

MEDIA CONTACT:

Larry Mimms, CEO

Larry.mimms@procisedx.com

Sales Contact

infoUS@procisedx.com

LINK