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ProciseDx Announces FDA Clearance of ProciseDx instrument and C Reactive Protein (CRP) Assay

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ProciseDx Inc. announces FDA clearance of its ProciseDx instrument and C reactive Protein (CRP) test. Procise CRP gives quantitative determination of CRP levels in patient serum in less than 5 minutes. ProciseDx expects FDA clearances of additional tests in 2023.

A first FDA Clearance is an important validation of ProciseDx’s new technology. ProciseDx has a menu of 5-minute gastroenterology and Therapeutic Drug Monitoring (TDM) tests available in Europe.

ProciseDx has obtained CE Marks and launched four gastroenterology (GI) tests in Europe. Already 30 ProciseDx instruments are installed and supporting patient care, with a further 50 sites working towards implementation. For the US market, 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

“Accurate quantitative diagnostic results have typically required big lab instruments and taken several hours or days,” said Larry Mimms, President & Chief Scientific Officer. “The ProciseDx platform can change that, with a simple workflow producing a reliable quantitative measurement in 5 minutes or less.”

Fast and accurate positive or negative Covid-19 diagnostic results have become familiar. But many medical decisions rely on a quantitative diagnostic result. The doctor needs a number, not just a positive or negative.

“Our San Diego team has worked exceptionally hard to bring this point of care quantitative immunoassay platform through FDA clearance,” continued Mimms. “We’re very excited to make tests available in the US.”

“Remicade and Humira are hugely important drugs for patients with IBD (Inflammatory Bowel Disease) and ProciseDx monitoring of these drugs is improving care in Europe,” said Peter Westlake, ProciseDx CEO. “ProciseDx technology is a real step forward, because it can deliver reliable quantitative results from a drop of blood in 5 minutes or less. We’re preparing to bring these additional ProciseDx 5-minute tests to doctors and patients in the US.”

ProciseDx expects to commercialize its GI and TDM menu in the US in 2023, launching with Procise IFX, Procise ADL and Procise CRP. 1

Licensing, Commercialization and Manufacturing Agreement

ProciseDx with its partner and shareholder, Biosynex S.A., also announce a Licensing, Commercialization and Manufacturing Agreement for Europe, Middle East and beyond. With immediate effect, Biosynex becomes responsible for supplying existing ProciseDx distributors for the region. ProciseDx Inc. retains all rights and responsibilities for US, Canada, China and Japan.

“FDA Clearance is major achievement for the ProciseDx team Biosynex has supported the development and commercialization of the ProicseDx platform. We’re delighted that Biosynex will use their market expertise to drive ongoing success of ProciseDx in Europe and the Middle East. Now that we have our first FDA Clearance, the US team is very focused on the opportunity here,” said Board Chair, Magda Marquet.

Biosynex will manufacture ProicseDx tests in Europe and plans to add to the ProciseDx platform menu.

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

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

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