ProciseDx Procise CRP Test Gets FDA Clearance
The FDA has granted 510(k) marketing clearance to ProciseDx’s finger prick blood test for detecting C reactive protein (CRP), a marker for inflammation.
The Procise CRP diagnostic test measures the level of C reactive protein in serum. C reactive protein is a marker of inflammation and increases with active diseases, making it particularly useful for monitoring inflammatory bowel disease.
The test delivers results in less than five minutes. This compares with several hours or days typically needed for accurate quantitative diagnostic results.
San Diego, Calif.-based ProciseDx expects to launch its Procise CRP test in the U.S. in 2023. The company previously gained CE Marks for four gastroenterology tests and has launched those products in Europe.