Breakthrough Diagnostic Technology Enables Quantitative Five-Minute Tests

But many medical decisions rely on a quantitative diagnostic result. The doctor needs a number, not just a positive or negative. Now, a breakthrough diagnostic technology enables quantitative five-minute tests that deliver easy, immediate and accurate results to expedite medical treatment.

ProciseDx Inc. (San Diego, CA, USA) has received 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 five minutes. The company expects FDA clearances of additional tests in 2023. ProciseDx has a menu of five-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). ProciseDx expects to commercialize its GI and TDM menu in the US in 2023, launching with Procise IFX, Procise ADL and Procise CRP.

"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 five minutes or less."

"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 five minutes or less. We're preparing to bring these additional ProciseDx five-minute tests to doctors and patients in the US."

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