CLN Article

News from the FDA

BD MAX MRSA Assay Granted a CLIA Moderate Complexity Rating

FDA granted the BD MAX MRSA molecular test a CLIA moderate complexity rating, allowing qualified laboratory technicians to perform the fully-automated test to identify patients colonized with methicillin-resistant Staphylococcus aureus (MRSA). "Healthcare institutions can now simplify and optimize their MRSA active surveillance testing in less than a minute of hands-on time per specimen with true walk-away automation," said Tom Polen, president of BD Diagnostics. According to the company, this new classification will help prevent transmission and reduce the rate of MRSA infections in hospitals, as well as decrease unnecessary preemptive isolation of patients.

Herpes Simplex Virus Types 1 and 2 Tests Cleared

FDA cleared Roche's Elecsys herpes simplex virus (HSV) types 1 and 2 IgG assays for use on cobas modular platforms, expanding the firm's infectious diseases test portfolio. Intended for use with sexually active individuals and expectant mothers, the tests are for qualitative determination of IgG class antibodies to HSV-1 and HSV-2 in human serum or plasma. "These are the first automated, type-specific herpes tests available for integrated analyzer platforms, which will enable labs to integrate efficient herpes testing into their existing workflow," said Randy Pritchard, vice president of marketing at Roche.

Clearance for LipoScience’s Vantera Clinical Analyzer

LipoScience has received FDA clearance for the automated Vantera Clinical Analyzer, a platform that identifies and quantifies lipoprotein concentrations using a mix of nuclear magnetic resonance (NMR) spectroscopic detection and proprietary signal processing algorithms. The low-density lipoprotein particle number (LDL-P) is the first assay cleared on the analyzer. As a critical component of LipoScience's NMR LipoProfile test, the LDL-P will help guide physicians in their management of patients' heart health. "Historically, all NMR LipoProfile tests have been performed at LipoScience's CLIA-certified laboratory in North Carolina," said Tom Clement, vice president of regulatory and quality affairs. "The 510(k) clearance of the Vantera Clinical Analyzer will allow us to place Vantera systems in select high-volume national and regional clinical diagnostic laboratories across the U.S."