Meso Scale Diagnostics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its conventional C-reactive protein (CRP) assay for in-vitro diagnostic (IVD) use in the United States. The assay uses MSD's proprietary MULTI-ARRAY technology, which has been used in life science research applications for nearly 20 years. CRP is a traditional diagnostic marker that has taken on additional importance as a biomarker in personalized medicine applications and companion diagnostics (CDx).
The cleared assay system includes the MESO SECTOR S 700, which is intended for the in-vitro determination of analytes in bodily fluids. This instrument utilizes the same hardware and firmware as the MESO SECTOR S 600, which MSD currently sells for life science research.
"After nearly 20 years of success in the life science research market, our first FDA clearance of an IVD is an important milestone for MSD,” Jacob Wohlstadter, President and Chief Executive Officer, said. “We look forward to expanding upon our expertise as an industry leader in highly sensitive multiplex immunoassays for research by exploring leading edge innovations in personalized medicine. This is a transformative time in health care and we are poised to add our proprietary technology and skill set to improving human health outcomes."