CLN Article

News From the FDA

Luminex Receives FDA Nod for Gastrointestinal Pathogen Panel

Luminex received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first molecular assay that tests for more than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single test. Diagnosis of some causes of infectious gastroenteritis has typically involved multiple microbiology, virology, and molecular tests that take several days to deliver results.

The xTAG GPP uses nucleic acid-based amplification technology to simultaneously test for 11 of the most common gastroenteritis causing viruses, bacteria, and parasites, and deliver multiple results within 5 hours. The panel of pathogens includes Campylobacter, Clostridium difficile Toxin A/B, Escherichia coli O157, Enterotoxigenic E. coli (ETEC) LT/ST, Shiga-like toxin producing E. coli (STEC) stx1/stx2, Salmonella, Shigella, Rotavirus A, Norovirus GI/GII, Giardia lamblia, and Cryptosporidium. The cleared test runs on the Luminex 100/200 system and uses a single stool sample.

FDA Clears Hologic Trichomonas vaginalis Assay

FDA has cleared Hologic's APTIMA Trichomonas vaginalis assay on the company's fully-automated PANTHER System. It is the only amplified nucleic acid test cleared by the FDA specifically for detecting Trichomonas vaginalis, a sexually transmitted parasite that is the most common curable sexually transmitted infection in the U.S.According to Hologic, the assay is quicker and more sensitive than most current tests that involve culture methods or the microscopic examination of a sample. Specimens from symptomatic or asymptomatic women include endocervical or vaginal swabs, as well as specimens collected in Hologic's ThinPrep vial.

One Lambda HLA Fusion Software Upgrade Cleared by FDA

FDA cleared One Lambda's HLA Fusion Software version 3.0, a companion analysis software to molecular typing and antibody screening products. This latest upgrade to the HLA Fusion Software line provides all the tools and applications from version 2.0 and its related service packs, along with support with Luminex xPONENT 3.1 acquisition software for LABScan 100, and more. Product families that can be used in conjunction with HLA Fusion include LABScreen and LABType products for antibody detection and HLA typing, respectively, as well as LAT, LCT, FlowPRA, and MicroSSP products. HLA Fusion also assists personnel trained in HLA analysis by suggesting typing and antibody screening results.

Cepheid's Xpert CT/NG Test Rated Moderate Complexity

Cepheid's Xpert CT/NG test has been categorized by the FDA as moderate complexity under CLIA. The qualitative molecular test detects and differentiates Chlamydia trachomatis and Neisseria gonorrhoeae and runs on Cepheid's GeneXpert Systems. The first and only test of this kind to be categorized as moderately complex, this allows more clinical sites to conduct the test.

DiaSorin Receives Clearance for Hypertension Immunoassay

FDA has cleared DiaSorin's LIAISON Direct Renin immunoassay as an aid in the diagnosis and treatment of certain types of hypertension. Designed for DiaSorin's automated, random-access LIAISON platform, the test is the first chemiluminescent immunoassay for direct renin.