Sam Brusco, Associate Editor11.08.22
ProciseDx has earned U.S. Food and Drug Administration (FDA) clearance for its ProciseDx instrument and C reactive protein (CRP) test. Procise CRP quantitatively determines CRP levels in patient serum in under five minutes.
The company expects FDA clearance of further tests in 2024. Procise Dx has a menu of five-minute gastroenterology (GI) and therapeutic drug monitoring (TDM) tests available in Europe.
The company obtained CE marks and launched four GI tests in Europe. For the U.S. market, the company 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).
"Accurate quantitative diagnostic results have typically required big lab instruments and taken several hours or days," Larry Mimms, Procise DX’s president and chief scientific officer told the press. "The ProciseDx platform can change that, with a simple workflow producing a reliable quantitative measurement in 5 minutes or less."
"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 U.S."
"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 U.S. in 2023, launching with Procise IFX, Procise ADL and Procise CRP.
The company expects FDA clearance of further tests in 2024. Procise Dx has a menu of five-minute gastroenterology (GI) and therapeutic drug monitoring (TDM) tests available in Europe.
The company obtained CE marks and launched four GI tests in Europe. For the U.S. market, the company 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).
"Accurate quantitative diagnostic results have typically required big lab instruments and taken several hours or days," Larry Mimms, Procise DX’s president and chief scientific officer told the press. "The ProciseDx platform can change that, with a simple workflow producing a reliable quantitative measurement in 5 minutes or less."
"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 U.S."
"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 U.S. in 2023, launching with Procise IFX, Procise ADL and Procise CRP.