US-based in-vitro diagnostics (IVD) company ProciseDx has secured the US Food and Drug Administration (FDA) approval for its ProciseDx instrument and C reactive Protein (CRP) test.

Procise CRP assay is designed to quantitatively determine the CRP levels in a patient’s serum within less than five minutes, leveraging the company’s trFRET and Lumiphore technologies.

The Lumiphore technology is said to enhance fluorescent emissions for prolonged periods compared to biological materials.

ProciseDx offers a collection of rapid gastroenterology (GI) and Therapeutic Drug Monitoring (TDM) tests in Europe and has rolled out four CE mark-approved GI tests in the EU.

The company claims that 30 ProciseDx instruments are already installed to support patient care in Europe, with an additional 50 sites underway for implementation.

ProciseDx president and chief scientific officer Larry Mimms said: “Accurate quantitative diagnostic results have typically required big lab instruments and taken several hours or days.

“The ProciseDx platform can change that, with a simple workflow producing a reliable quantitative measurement in five minutes or less.

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

ProciseDx has filed De Novo applications with the US FDA for two TDM tests, Procise IFX and Procise ADL for launching them in the US market.

Procise IFX measures infliximab, sold under the brand name Remicade, and its biosimilars. Procise ADL measures adalimumab, also called Humira, and its biosimilars.

The company anticipates the FDA approval of additional tests in 2023, and commercialises its TDM tests in the US, starting with Procise IFX, Procise ADL, and Procise CRP.

ProciseDx CEO Peter Westlake said: “Remicade and Humira are hugely important drugs for patients with Inflammatory Bowel Disease (IBD) and ProciseDx monitoring of these drugs is improving care in Europe.

“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 5-minute tests to doctors and patients in the US.”

Last month, ProciseDx signed an agreement with its partner Biosynex for licensing, manufacturing, and marketing of its products in Europe, the Middle East and beyond.

The company has retained all rights and responsibilities for the US, Canada, China, and Japan.

Under the deal, Biosynex will manufacture ProicseDx tests in Europe, and start supplying existing ProciseDx distributors for the region.

Biosynex deputy CEO Thierry Paper said: “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.”