NEW YORK – The US Food and Drug Administration in March granted 510(k) clearances for tests by BioMérieux, Abbott, and DiaSorin, among others.
BioMérieux subsidiary BioFire nabbed clearance for its Global Fever Special Pathogens Panel, a blood-based multiplex PCR test with DNA melt analysis for detection and identification of bacterial, viral, and protozoan pathogens in patients with suspected febrile illness. The test is intended for use on BioFire's FilmArray 2.0 and FilmArray Torch instruments and it delivers results in about one hour.
The test identifies chikungunya, dengue, and West Nile viruses as well as Leptospira, Leishmania, and Plasmodium species. It also provides presumptive identification of Crimean-Congo hemorrhagic fever virus, Ebola virus, Lassa virus, Marburg virus, yellow fever virus, Bacillus anthracis, Francisella tularensis, and Yersinia pestis. The Global Fever Special Pathogens Panel has a wider range of pathogens detected than its predecessor Global Fever Panel, which is used to detect chikungunya and dengue viruses, Leptospira species, and Plasmodium species.
BioMérieux also locked up clearance for its Vitek 2 AST-Gram Negative Fosfomycin antimicrobial susceptibility test, which is used to detect antimicrobial susceptibility in Escherichia coli. The automated test uses a microdilution-based minimum inhibitory concentration technique and is designed for use on Vitek 2 and Vitek 2 Compact instruments.
Abbott got a green light for its TBI panel for identification of traumatic brain injury in adults within 12 hours of the suspected injury. The Illinois-based firm's automated chemiluminescent microparticle immunoassay measures glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1 concentrations in blood, and elevated concentrations are correlated with brain injury. The panel is designed for use on the Alinity I system and it delivers results in 18 minutes, with a negative result ruling out a CT scan.
Abbott also secured 510(k) clearance for an update to its real-time PCR-based Alinity M STI Assay for detection and differentiation of DNA from Neisseria gonorrhoeae and ribosomal RNA from Chlamydia trachomatis, Trichomonas vaginalis, and Mycoplasma genitalium. The update expands which of those infections can be detected using certain types of gynecological or urine samples.
The assay is designed for use on the automated Alinity M instrument. With the updates, it can use vaginal swab, endocervical swab, or male urine samples for detection of all four targets; gynecological specimens in ThinPrep PreservCyt Solution or female urine for detection of all but M. genitalium; and oropharyngeal swab or rectal swab samples for detection of only C. trachomatis and N. gonorrhoeae.
Saluggia, Italy-based DiaSorin got the go-ahead for its real-time RT-PCR Simplexa COVID-19 & Flu A/B Direct assay, which uses nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection. The test differentiates between infections with SARS-CoV-2 and influenza A and B viruses and is designed for laboratory use on the company's Liaison MDX instrument. The firm said the test delivers results in a little more than one hour and up to eight samples can be tested at once in a streamlined, simple workflow that requires minimal hands-on time and no sample extraction.
Franklin Lakes, New Jersey-based Becton Dickinson got a go-ahead for a high-throughput real-time PCR BD Vaginal Panel for detection of common causes of vaginitis. Using a single vaginal swab sample, the panel can detect and distinguish bacterial vaginosis, T. vaginalis, and vulvovaginal candidiasis, with separate results for Candida glabrata and C. krusei. The test is designed for use with the firm's BD Cor instrument, which can deliver about 2,000 results in 24 hours, and a version of the panel is designed for use on the BD Max System.
San Jose, California-based Visby Medical also nabbed FDA clearance for its second-generation point-of-care Sexual Health Test, a disposable single-use automated PCR-based test for use in point-of-care or clinical laboratory settings for identification of C. trachomatis, N. gonorrhoeae, and T. vaginalis using vaginal swab specimens. The test delivers results in about 30 minutes, and the firm said in March the new version of the device provides improvements in workflow, manufacturability, and reliability compared with the first-generation device cleared in 2021.
And Texas-based firm Healgen Scientific secured FDA 510(k) clearance for a pair of lateral-flow chromatographic immunoassays for detection of marijuana consumption. The firm's Accurate Oral Fluid Drug Test is a prescription-use test for detecting consumption through cotinine and THC in oral fluid specimens, and the firm's Accurate Oral Fluid Drug Test COT is an over-the-counter test for detection through cotinine alone.