Industry Press Releases

Meso Scale Diagnostics Receives First FDA Clearance for IVD Assay

Wednesday, Jan 31, 2018

Meso Scale Diagnostics, LLC. (MSD) is pleased to announce that it 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 widely 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.  

Jacob Wohlstadter, President and Chief Executive Officer, remarked, "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.  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."

"Personalized medicine and CDx are creating a growing demand for new diagnostic tests based on novel biomarkers," said James Wilbur, General Manager of Meso Scale Discovery, a division of MSD.  "MSD now has a cleared platform, which lowers the barrier to commercialization of future tests and provides an attractive alternative to traditional diagnostic test systems."

About Meso Scale Diagnostics, LLC.

Meso Scale Diagnostics, LLC., based in Rockville, Maryland, develops, manufactures, and markets instruments and assays for array-based biological measurements for research use in life sciences and for biodefense applications. MSD is the world's leading provider of highly sensitive multiplex immunoassays. More information about MSD and its products can be found at www.mesoscale.com.

 

Source: prnewswire.com

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