A new draft guidance from the National Institute for Health and Care Excellence (NICE) recommends the NHS use fecal immunochemical tests (FITs), instead of guaiac-based tests, for detecting gastrointestinal bleeding associated with bowel cancer.

Emerging Irish IVD company HiberGene Diagnostics has just CE marked HG Meningococcus, a molecular diagnostic test for bacterial meningitis that can detect Neisseria meningitidis in cerebrospinal fluid, whole blood and via a nasopharyngeal swab in less than one hour. The company is set to launch the test in Europe with distribution agreements in place for Ireland, Germany, Austria, Spain, Turkey and Poland.

Dublin-based start-up HiberGene Diagnostics Ltd. aims to create rapid, accurate, and simple diagnostic tests for infectious diseases based on LAMP (loop-mediated isothermal amplification) technology, which uses nucleic acid amplification to identify target genes.

Six quality-related FDA close-out letters were released from Aug. 12 through Sept. 11.