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Roche, Thermo Fisher Scientific, DiaSorin, BioMérieux, and Others Obtain FDA Clearances in September

NEW YORK ─ The US Food and Drug Administration granted 510(k) clearances in September for tests from DiaSorin, BioMérieux, Roche, Thermo Fisher Scientific's Phadia, and others, according to the agency's website.

Roche got the green light for three tests, including for a modification to its Elecsys Troponin T Gen 5 immunoassay, first cleared in 2017, for the quantitative measurement of cardiac troponin T to diagnose myocardial infarction. The modification decreases interference to biotin for the electrochemiluminescence test, which runs on Roche's Cobas e immunoassay analyzers.

The Basel, Switzerland-based company also obtained clearance for a software update to its molecular assay for C. difficile, the Cobas Cdiff Nucleic Acid test, which also was first cleared by the FDA in 2017 and runs on the firm's Liat point-of-care analyzer to detect the toxin B gene of toxigenic C. difficile in stool specimens.

For its third clearance in September, Roche got the go-ahead for its Elecsys Vitamin D Total III assay running on the firm's Cobas e immunoassay analyzers for the quantitative determination of total 25-hydroxyvitamin D to assess vitamin D sufficiency in adults.

Waltham, Massachusetts-based Thermo Fisher Scientific's Phadia business nabbed a clearance for its EliA Rib-P test for the semi-quantitative measurement of IgG antibodies against ribosomal P-proteins. The test is used to diagnose systemic lupus erythematosus in conjunction with other laboratory and clinical findings.

Phadia also nabbed a clearance for its EliA RNA Pol III test for the semi-quantitative measurement of IgG antibodies against RNA polymerase III. The test is used to diagnose systemic sclerosis in conjunction with other laboratory and clinical findings.

Meanwhile, Thermo Fisher Scientific's Microgenics business obtained clearance for its DRI Cocaine Metabolite enzyme immunoassay running on Abbott's Alinity c clinical chemistry analyzer. The test is used for the qualitative and/or semi-quantitative determination of benzoylecgonine, a cocaine metabolite, in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL.

Saluggia, Italy-based DiaSorin obtained clearance for its Liaison Ferritin chemiluminescent immunoassay running on its Liaison XL analyzer to detect ferritin and aid in the diagnosis of anemia related to iron deficiency and iron overload.

BioMérieux, based in Marcy-l'Étoile, France, nabbed an FDA clearance for its Vitek 2 AST-Gram Positive Fosfomycin antimicrobial susceptibility test, running on the firm's Vitek 2 and Vitek 2 Compact systems. The test is used for the quantitative determination of susceptibility to antimicrobial agents, including most strains of Enterococcus faecalis. The antimicrobial agent fosfomycin has been shown to be active against most strains of E. faecalis.

In other FDA news during September, Rockville, Maryland-based OpGen announced it received the green light for its Acuitas AMR Gene Panel, a PCR-based test that detects 28 genetic antimicrobial resistance markers in isolated bacterial colonies from 26 different pathogens in less than three hours. Tirat Carmel, Israel-based MeMed announced it has received FDA clearance for its MeMed BV test on its MeMed Key platform, which measures a panel of host-response proteins to help distinguish between bacterial and viral infections.