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BioMérieux, Siemens Healthineers, Roche Diagnostics, Others Get FDA Clearances in August

NEW YORK – The US Food and Drug Administration cleared in vitro diagnostic tests and systems in August from BioMérieux, Siemens Healthineers, Roche Diagnostics, Binx Health, and others, according to the agency's website.

BioMérieux received clearance for its ETest Imipenem/Relebactam, a thin plastic strip with a minimum-inhibitory-concentration scale on one side and a predefined antibiotic gradient on the other. Clinicians use the test to determine the minimum inhibitory concentration of Imipenem/Relebactam, a carbapenem-β-lactamase inhibitor combination, against Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

A second BioMérieux test that received clearance in August, the Vitek 2 AST-Gram Negative Eravacycline assay, is used for antimicrobial susceptibility testing of Gram-negative bacilli, running on the firm's Vitek 2 and Vitek 2 Compact systems.

The FDA cleared Siemens Healthineers' Advia Centaur Testosterone II assay, used to detect total testosterone while running on the firm's Advia Centaur XP system. Testosterone measurements are used in the diagnosis and treatment of disorders involving male sex hormones, including primary and secondary hypogonadism, delayed or precocious puberty, and impotence. In females, testosterone measurements are used in the diagnosis and treatment of hirsutism, or excessive hair, and virilization, or masculinization, due to tumors, polycystic ovaries, and adrenogenital syndromes.

A second Siemens Healthineers test to receive clearance in August, the Advia Centaur SHBG immunoassay running on the Advia Centaur XP system, measures sex hormone-binding globulin (SHBG), which is used to diagnose androgen disorders.

Axis-Shield Diagnostics received clearance for its Advia Centaur Erythropoietin assay, which is used in the diagnosis of anemias and polycythemias while running on the Siemens Advia Centaur XP system.

Roche Diagnostics got the nod for its Elecsys Anti-HAV II test used to detect total antibodies — IgG and IgM — to the hepatitis A virus. The test, an electrochemiluminescence immunoassay, runs on Roche's Cobas e immunoassay analyzers. In conjunction with other serological and clinical information, the assay is used to diagnose acute or past hepatitis A virus infection in people who have symptoms of the infection and in those who are at increased risk of acquiring it. The Roche assay is also used to determine the presence of an antibody response to the hepatitis A virus in vaccine recipients.

The FDA cleared Grifols' QNext fully automated random-access instrument, which is used in clinical laboratories to perform hemostasis testing by detecting changes in optical density. The firm also got the nod for a thromboplastin reagent test, DG-PT, running on the QNext instrument and used to determine prothrombin time and monitor oral anticoagulant therapy.

The FDA granted clearance to Fujirebio Diagnostics for its Lumipulse G Whole PTH, a chemiluminescent enzyme immunoassay used to measure parathyroid hormone levels during the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

Check-Points got the nod for the BD Max Check-Points CPO Assay running on the Becton Dickinson BD Max System. The automated real-time PCR test is used for the detection and differentiation of the carbapenemase genes blaKPC, blaNDM, blaVIM/blaIMP, and blaOXA-48, which are associated with carbapenem non-susceptibility in Gram-negative bacteria.

The FDA granted clearance for Healstone Biotech's Accurate Multi Panel Drug Urine Test Cup, a lateral flow immunochromatographic assay for detection of a combination of two to 15 drugs of abuse.

In August, the FDA cleared the Binx Health io platform, which provides sample-to-answer results in about 30 minutes for the detection of chlamydia and gonorrhea. The agency also gave the nod to Drawbridge Health for its OneDraw A1C Test System, a blood collection device and HbA1c test.

The agency also approved Agilent Technologies' Dako PD-L1 IHC 22C3 pharmDx assay as a companion diagnostic test for Merck's anti-PDL-1 immunotherapy pembrolizumab (Keytruda) for esophageal squamous cell carcinoma.