May 12, 2020 -- Nestlé Health Science subsidiary ProciseDx said that it has submitted a 510(k) application for its Procise point-of-care C-reactive protein (CRP) test to the U.S. Food and Drug Administration (FDA) and is preparing for the European launch of several assays.
Performed using the company's Fluorescence Resonance Energy Transfer (FRET) point-of-care instrument, the finger-stick test measures CRP levels from whole blood in two minutes, according to ProciseDx.
The test is a first in a planned series of two- to five-minute finger-stick whole blood lab tests available on the Procise Dx instrument. In the third quarter, ProciseDx will launch assays that measure levels of the drugs infliximab (Remicade) and adalimumab (Humira) in multiple markets. The company also plans to offer a fecal calprotectin assay.
In related news, ProciseDx has appointed Jacques Cavadenti to be vice president of international business. Cavadenti joins ProciseDx from GenMark, where he served as vice president and general manager, Europe.