C. difficile
PCR Technology Agreement with Focus Diagnostics Marks ‘Renewed Focus’ on Life Sciences for Evogen
Focus Diagnostics of Cypress, CA, has licensed the worldwide rights to incorporate Evogen’s HyBeacons PCR probe technology for use in molecular products and services, the companies announced. The technology has multiplex capability for identifying several targets in a single reaction, according to Evogen. Focus, a subsidiary of Quest Diagnostics, specializes in testing for infectious diseases and manufactures the Simplex line of test products for diagnosing flu, C. difficile, Epstein-Barr...
Meridian Bioscience Awarded Agreement with GPO Premier for Molecular Diagnostics
Meridian Bioscience Inc. announced it has signed a new group purchasing agreement with Premier healthcare alliance to offer Illumigene C. difficile and Illumigene Group B Streptococcus to its members at specially negotiated pricing. Premier is a group purchasing organization (GPO) that serves upward of 2500 U.S. hospitals and 81,000-plus other healthcare sites. This new agreement allows facilities doing business with Premier to implement rapid, sensitive molecular...
Meridian Bioscience Plans To Launch Several New Illumigene Tests
Included in Meridian Bioscience's press release summarizing the company's fourth-quarter and full-year earnings are comments regarding soon-to-be-launched Illumigene tests. Illumigene is a molecular-amplification platform. Meridian Bioscience says in the release that it is awaiting FDA clearance to market two new tests: Illumigene GBS for streptococcus Group B, and ImmunoCardSTAT! GDH, a rapid screening test for C. difficile. "In addition," the release reads, "we expect two to...
Meridian Bioscience Receives FDA Clearance For New Pediatric Claim
Meridian Bioscience Inc. (Cincinnati, OH) has received clearance from FDA for a new pediatric claim for its illumigene C. difficile (Clostridium difficile) molecular amplification test. The illumigene molecular test is designed to target the region of the C. difficile DNA that is presented in all toxin A and/or toxin B producing strains. The illumigene test provides highly accurate results in under an hour. Meridian Bioscience’s illumigene test is the only C. difficile test that is...
Draft Guidance Released for C. difficile Diagnostic Devices
 FDA issued a draft guidance for industry and FDA staff on November 29 that is of interest to IVD manufacturers who design and produce tests for the detection of Clostridium difficile. The guidance, "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile," is being distributed to industry and the regulatory community for feedback. Those wanting to submit comments or suggestions regarding the contents of the guidance...