This article has been updated from a previous version to correct the technology used in the Meridian H. Pylori assay.
NEW YORK (GenomeWeb) – DiaSorin Molecular said today that it has received CE marking for its Simplexa Group B Strep Direct assay.
Italy-based DiaSorin noted on its website that the molecular assay — designed for use on the firm's real-time PCR-based Liaison MDx instrument — uses lim broth-enriched vaginal or rectal swabs to identify group B Streptococcus DNA in about an hour. The new assay is more specific than traditional testing methods and offers an efficient and fast workflow, the firm said.
DiaSorin also noted that it has submitted the new assay for 510(k) clearance from the US Food and Drug Administration.
The CE mark follows a similar designation that DiaSorin received earlier this month for its Simplexa VZV Direct assay, also running on the Liaison MDx instrument, to detect varicella-zoster virus from a patient's spinal fluid. The company previously announced that it has partnered with Meridian BioScience to sell the Helicobacter pylori stool antigen test on another Liaison platform, the Liaison Analyzer, an immunoassay system that uses chemiluminescence technology with a paramagnetic microparticle solid phase.