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DiaSorin, Abbott, Roche, BioMérieux, Others Gain FDA Clearances in July

NEW YORK — DiaSorin expanded its diagnostics offerings in July with US Food and Drug Administration 501(k) clearance of a pair of assays, while in vitro diagnostic tests and testing systems from Abbott, Roche, BioMérieux, and others also received clearances, according to the FDA's website.

Saluggia, Italy-based DiaSorin gained clearance for the Liaison Calprotectin, a chemiluminescent immunoassay for detecting fecal calprotectin, which is a marker of mucosal inflammation. The test, which is for use with the Liaison platform, can help physicians diagnose inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis, and differentiate them from irritable bowel syndrome.

DiaSorin also received FDA clearance fast month for its Liaison MeMed BV, a high-throughput chemiluminescent immunoassay to differentiate between bacterial and viral infections, which could help physicians target treatments and reduce antibiotic overuse, according to the company. The FDA said that the assay, used on DiaSorin's Liaison platform, is indicated for use on samples collected from patients who arrive at emergency departments or urgent care centers with suspected acute infections.

Abbott Park, Illinois-based Abbott Molecular chalked up clearance for a PCR assay, Alinity m EBV, which is used on Abbott's Alinity m system to quantify Epstein-Barr virus DNA. The assay can be used to help manage the virus in transplant patients, and in people undergoing treatment for Epstein-Barr infections, serial measurements can help indicate the need for treatment changes, according to the FDA.

Basel, Switzerland-based Roche received the go-ahead to sell its real-time PCR assay for influenza A and B viruses and respiratory syncytial virus for use on Roche's Cobas Liat System. The Influenza A/B & RSV assay is intended for rapid detection and discrimination among those viruses in samples collected with nasopharyngeal swabs.

French firm BioMérieux received a pair of 501(k) clearances, one for the company's Vitek 2 AST-Yeast Caspofungin assay, which is used on the company's Vitek systems to test Candida species for susceptibility to the antifungal agent caspofungin.

Company officials previously announced they had secured clearance for the Vidas Nephrocheck, an assay used to detect biomarkers of kidney stress prior to more serious injury. The FDA said the test is used to assess the risk to patients who are in an intensive care unit following cardiovascular or respiratory compromise, and it detects in urine the biomarkers tissue inhibitor of metalloproteinases-2, or TIMP-2, and insulin-like growth factor-binding protein 7, or IGFBP-7.

BioMérieux subsidiary BioFire Defense also gained clearance for an updated version of its COVID-19 real-time PCR test for use with BioFire FilmArray systems. The FDA first cleared the BioFire COVID-19 Test 2 in November 2021, and the recent submission shows results from four more assays that could help maintain the assay's sensitivity to infections with SARS-CoV-2 variants, the FDA said.

Meantime, Franklin Lakes, New Jersey-based Becton Dickinson now has federal clearance for two assays for the detection and differentiation of bacteria that cause gastrointestinal disease. The BD Max Enteric Bacterial Panel, for use on the BD Max System, is used to analyze stool samples and detect nucleic acids of Salmonella, Campylobacter, and Shigella species, and Shiga toxin produced by Shiga toxin-producing Escherichia coli and Shigella dysenteriae. The BD Max Extended Enteric Bacterial Panel is used in conjunction with the other panel to detect nucleic acids of Plesiomonas shigelloides, Vibrio species, Enterotoxigenic E. coli heat-labile enterotoxin or heat-stable enterotoxin genes, and Yersinia enterocolitica.

Thermo Fisher Scientific, through its Phadia subsidiary, received clearance for two assays used to help diagnose Sjogren's syndrome, systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathies. The assays are intended for semi-quantitative measurement of IgG autoantibodies specific to Ro52 and Ro60 in human serum.

Also, Uppsala, Sweden-based Biovica International received clearance for its DiviTum TKa assay to monitor disease progression in certain breast cancer patients. The assay measures thymidine kinase activity in blood.

Lastly, nabbed FDA clearance last month for its home-use kidney health test.