Luminex said this week that it has received clearance from the US Food and Drug Administration for its MagPix instrument and xTAG Gastrointestinal Pathogen Panel, or GPP.
The xTAG GPP assay is the first clinical assay to be cleared in the US for the MagPix instrument, and is also the first FDA-cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single stool sample, Luminex said.
Specifically, xTag GPP tests for Campylobacter; Clostridium difficile Toxin A/B; Escherichia coli 0157; enterotoxigenic E. coli LT/ST; Shiga-like toxin-producing E. coli stx1/stx2; Salmonella; Shigella; Rotavirus A; Norovirus GI/GII; Giardia lamblia; and Cryptosporidium.
FDA in January cleared xTAG GPP test for use on the previously approved Luminex 100/200 system.
The company said that MagPix is an easy-to-use and versatile multiplexing platform capable of performing qualitative and quantitative analysis of proteins and nucleic acids in a variety of sample matrices.
In addition, MagPix is compact, making it attractive to laboratories with limited bench space; and can perform up to 50 different tests in a single reaction volume, greatly reducing sample input, reagents, and labor while improving productivity, Luminex said.
While traditional GI testing technologies and methods can take several days to deliver a single result depending on the pathogen, xTAG GPP can deliver multiple results within five hours.
Becton Dickinson's BD Diagnostics unit and Diagenode this week announced the availability of the CE-marked Diagenode Enteric Viral Panel for use with the BD Max system.
In addition, BD Diagnostics announced the availability of the CE-marked BD Max Enteric Bacterial Panel.
The Diagenode Enteric Viral Panel primers and probes kit, designed under a partnership between Diagenode and BD, is intended to be used with the BD Max RNA extraction kit RNA3 and BD Max PCR cartridges. It is an automated in vitro diagnostic test for the qualitative detection of norovirus (genogroups I and II) and rotavirus species in stool specimens.
Meantime, the BD Max Enteric Bacterial Panel is a qualitative IVD test to detect DNA from Campylobacter jejuni and coli; Salmonella spp., Shigellosis disease (Shigella spp./enteroinvasive Escherichia coli; as well as Shiga-toxin types 1a and 2a in stool specimens.
In addition to panels detecting enteric viral and bacterial pathogens, a BD Max Enteric Ovum and Parasite Panel is currently in development for the qualitative detection of parasitic enteric pathogens Giardia lamblia, Cryptosporidium spp., and Entamoeba histolytica directly from stool specimens in patients with signs and symptoms of gastroenteritis and/or colitis.
BD said that it plans to continue expanding the BD Max molecular testing menu through internal development and the Diagenode collaboration by launching additional assays throughout 2013.
BioFire Diagnostics said this week that it has submitted the FilmArray Blood Culture Identification Panel to the US Food and Drug Administration for 510(k) clearance.
The submission comes after the successful completion of clinical trials for the FilmArray BCID Panel, which provides automatic results for the most common infectious causes of sepsis, a significant cause of mortality and morbidity in adults, children, and infants.
BioFire said that it anticipates commercial release of the panel in summer 2013, pending FDA clearance.
Using an easy procedure requiring only two to three minutes of hands-on time, the BCID Panel simultaneously tests positive blood cultures for approximately 90 percent of the gram-positive bacteria, gram-negative bacteria, and yeast microbes that cause bloodstream infections. In addition, the BCID Panel tests for common antimicrobial resistance genes associated with methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococci, and the newly emerging carbapenem-resistant Enterobacteriaceae.
IntelligentMDx said this week that it has obtained CE marking for the IMDx Flu A/B and RSV assay, a multiplexed real-time PCR test to detect and differentiate influenza A, influenza B, and respiratory syncytical virus.
The test is the fifth in a portfolio of CE-marked infectious disease assays designed by IMDx for use on the Abbott m2000 RealTime system.
The IMDx Flu A/B and RSV assay automatically tests up to 94 patient samples per run with minimal hands-on time. Results are obtained directly from an upper respiratory tract specimen from a symptomatic patient. The test can detect multiple Flu A/B and RSV strains, including recently emerging H3N2 variants.
The assay is not available for sale in the US or Canada.