Breakthrough ProciseDx diagnostic technology enables quantitative 5-minute tests for Therapeutic Drug Monitoring

San Diego, CA- ProciseDx Inc. announces that it is being acquired by Biosynex S.A., a French diagnostics company that specializes in point of care testing. With the support of the Biosynex Group, ProciseDx expects to commercialize the first FDA approved infliximab and adalimumab drug monitoring tests later this year.

ProciseDx technology enables Therapeutic Drug Monitoring (TDM) tests at point-of-care.  Biosynex Group’s strong commitment to TDM was demonstrated earlier this year, when Biosynex took control of Theradiag S.A., the leading European provider of biologic TDM testing kits for centralized laboratories.

Together, ProciseDx and Theradiag can transform biologic drug monitoring for US patients. Currently, testing in the US for biologic drug levels is slow and expensive. ProciseDx and Theradiag plan to bring fast, reliable and economic testing to US patients. ProciseDx has submitted De Novo applications to the FDA for two TDM tests.  Procise IFX measures infliximab (Remicade® and biosimilars) and Procise ADL measures adalimumab (Humira® and biosimilars).1

“Currently, results for drug concentrations for infliximab and adalimumab take days and require expensive shipment to third party laboratories.” said Larry Mimms, Chief Scientific Officer of ProciseDx.

“The ProciseDx platform can change that, with a simple workflow producing a reliable quantitative measurement in 5 minutes or less.  Remicade (infliximab) and Humira (adalimumab) are hugely important drugs for patients with IBD (Inflammatory Bowel Disease) and ProciseDx blood tests for concentrations of infliximab and adalimumab will improve US patient care”. 1

“I want to thank the ProciseDx team that is fighting hard to bring this innovation to US IBD patients.” said ProciseDx CEO Peter Westlake. 

“This new technology can improve quality, lower cost and give faster results. ProciseDx expects to launch infliximab and adalimumab point of care tests in the US later this year.  The Biosynex acquisition of ProciseDx will enable us to reach more patients, faster.”

Thierry Paper, Directeur Général Délégué (deputy CEO, Biosynex S.A. , Strasbourg, France) commented:

“Biosynex has made Point of Care and Therapeutic Drug Monitoring a strategic focus.  Biosynex have demonstrated our expertise in rapid testing through the Covid pandemic.  We see many potential areas of expansion for the ProciseDx technology and we are excited to welcome ProciseDx to the Biosynex Group.”

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