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Cepheid, DiaSorin, Thermo Fisher, and Others Receive FDA Clearances in August

NEW YORK (360Dx) – Cepheid, DiaSorin Molecular, Thermo Fisher Scientific, and Quidel were among the companies that received US Food and Drug Administration clearances in August for their in vitro diagnostic tests, according to the FDA website.

Danaher's Cepheid was granted 510(k) clearance for the Xpert Xpress Flu Assay performed on the GeneXpert Instrument System implementing a new software version. The clearance involved an expanded intended use claim that includes nasal swab specimens as an additional cleared type of specimen. It's now cleared for use with nasopharyngeal swab and nasal swab specimens collected from patients with signs and symptoms of respiratory infection.

The FDA cleared DiaSorin Molecular's Simplex Bordetella Direct real-time PCR assay system for the direct amplification, detection, and differentiation of Bordetella pertussis and Bordetella parapertussis DNA from unprocessed nasopharyngeal swabs. Bordetella is the causative agent of pertussis, or whooping cough.

Microbiologics received clearance for the BD Max CT/GC/TV 20-Day QC Panel, an external assayed positive quality control material designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in genitourinary specimens.

Assure Tech received clearance for its AssureTech Panel Dip Tests and AssureTech Quick Cup Tests, which are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of amphetamine, oxazepam, cocaine, marijuana methamphetamine, morphine, oxycodone, secobarbital, buprenorphine, methylenedioxy-methamphetamine, phencyclidine, methadone, EDDP, nortriptyline and d-propoxyphene in human urine.

Thermo Fisher Scientific received clearance for the addition of Plazomicin at concentrations 0.06 to 128 µg/mL to the Sensititre 18-24 MIC for susceptibility testing of non-fastidious gram-negative organisms.

Biokit, part of Werfen, was granted clearance for use of the Advia Centaur Herpes-2 IgG assay in the qualitative determination of IgG antibodies to herpes simplex virus type 2 in human serum and plasma, using Siemens Healthineers' Advia Centaur systems. The test is indicated for testing sexually active adults or expectant mothers and for aiding in the presumptive diagnosis of herpes simplex virus infection.

A test from Quidel to detect antibodies to the bacterial pathogen that causes Lyme disease was cleared and CLIA waived. Called Sofia 2 Lyme FIA, the test is a fluorescent immunoassay for human IgM and IgG antibodies to Borrelia burgdorferi that runs on the firm's Sofia 2 immunoassay reader.

Gastrointestinal diagnostics firm Techlab received 510(k) clearance for two of the company's tests to aid in diagnosing H. pylori infection.

The FDA cleared Hologic's Group B Streptococcus assay on the Panther Fusion system.

It also cleared the Inova Diagnostics Quanta Flash HMGCR marker, which aids in the diagnosis of idiopathic inflammatory myopathy, a group of conditions that affect the skeletal muscles and can lead to progressive muscle weakness, including tissue necrosis and disability.

Startup PapGene received Breakthrough Device designation for its blood-based cancer diagnostic assay based on the assay's ability to detect both ovarian and pancreatic cancer.

And the FDA approved the Roche Cobas EGFR Mutation Test v2 as a companion diagnostic test with AstraZeneca's cancer drug Iressa (gefitinib) for first-line treatment of patients with non-small cell lung cancer.