NEW YORK – Nestlé Health Science subsidiary ProciseDx said today that it has received CE marking for a point-of-care instrument platform.
ProciseDx said it is developing a broad portfolio of rapid point-of-care tests for use with the instrument in physician offices, retail clinics, and urgent care settings. The San Diego, California-based firm is developing diagnostic and treatment monitoring tests to quantify markers for inflammatory and auto-immune diseases, such as celiac disease, and metabolic syndromes, such as diabetes and pre-diabetes.
The firm said it anticipates launching the platform in Europe next year and is completing its first round of external financing in the first quarter of 2020, which would enable it to expand its assay menu in the US and Europe.
The test developer has been working in stealth mode with Nestlé's support for three years to develop the diagnostic platform, ProciseDx CEO Larry Mimms said in a statement. He added that ProciseDx is conducting clinical trials in the US with plans to submit a 510(k) clearance application to the US Food and Drug Administration for the platform and its first assay in Q1 2020.