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BioMérieux, Biocartis, Beckman Coulter Gain FDA 510(k) Clearances in February

NEW YORK – The US Food and Drug Administration granted 510(k) clearances in February to tests and assays from BioMérieux, Biocartis, and Beckman Coulter, among others, according to the agency's website.

The agency gave the go-ahead to BioMérieux subsidiary BioFire Diagnostics for the firm's Spotfire Respiratory Panel, which uses nasopharyngeal swab-collected samples from patients with symptoms of respiratory tract infection in a multiplexed PCR test for detection and identification of viral and bacterial nucleic acids. In about 15 minutes, the panel can identify adenovirus, seasonal coronavirus, SARS-CoV-2, human metapneumovirus, human rhinovirus or enterovirus, influenza A, influenza A/H1-2009, influenza A A/H3, influenza B, parainfluenza, respiratory syncytial virus, Bordetella parapertussis, B pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae.

Belgium-based Biocartis nabbed clearance for its Idylla MSI Test to screen for Lynch syndrome in colorectal cancer patients through qualitative identification of microsatellite instability in formalin-fixed, paraffin-embedded colorectal cancer tumor tissue. The test uses PCR amplification and melt curve analysis of seven monomorphic biomarkers.

German firm Leica Biosystems, part of Danaher, also got a nod for its test for human mismatch repair deficiencies that can help identify hereditary nonpolyposis colorectal cancer or Lynch syndrome. Called the Bond MMR Antibody Panel, it uses immunohistochemical staining and light microscopy for qualitative identification of four human mismatch repair proteins in formalin-fixed, paraffin-embedded colorectal cancer tissue. The panel is designed for use on the fully automated Bond-III and Bond-Max instruments with Bond Polymer Refine Detection.

Danaher's Beckman Coulter secured 510(k) clearance for a version of its Access Anti-Mullerian Hormone Assay for use on the company's Dxl 9000 Access Immunoassay Analyzer. The test had previously been cleared for use on the Access 2 Immunoassay System. The paramagnetic particle chemiluminescent immunoassay is used in fertility clinics to assess ovarian reserve using quantitative determination of AMH levels in human serum and lithium heparin plasma.

Beckman Coulter also got the green light for a new version of its Access Cortisol assay for determining cortisol levels in human serum, plasma, and urine. The new version of the paramagnetic particle chemiluminescent immunoassay is cleared for use on the Dxl 9000 Access Immunoassay Analyzer. The previous version of the test was designed for use on the Access Immunoassay System.

Lastly, Danaher's Cepheid nabbed clearance for a new version of its Xpert FII &FV test, a qualitative genotyping test for the detection of factor II and factor V alleles from sodium citrate or EDTA anticoagulated whole blood. The test, which aids diagnosis of thrombophilia, is cleared for use on the Cepheid GeneXpert Infinity instruments in addition to the previous version's clearance for use on the GeneXpert Dx instruments.

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