The Erytra Eflexis is a fully automated benchtop analyzer for pretransfusion compatibility testing that facilitates multiple lab configurations and features real random access.
The company expects to miss the consensus Wall Street revenue estimates for Q4 and full-year 2018.
A lack of attractive targets, high valuations, and a more attractive IPO market contributed to a 45 percent year-over-year decline in M&A.
The year saw the launch of high-profile platforms as well as efforts by a number of parties to streamline mass spec technologies for the clinic.
Sysmex accuses 13 Beckman Coulter instruments of infringing 11 claims in the patent, which covers a system analyzer and a computer program.
The mass spectrometry-based tests measure the level of five proteins in patient serum to assess cholesterol efflux capacity and risk of coronary artery disease.
The FDA cleared BD's test for detecting carbapenemase-producing organisms, which can be used by hospitals to contain the spread of antimicrobial resistance.
The FDA cleared LabCorp's assay for quantitative determination of total cholesterol, high density lipoprotein cholesterol, triglycerides, and apolipoprotein B.
Used with other clinical evidence, Siemen Healthineer's blood-based test aids clinicians in assessing the fibrosis stage of chronic liver disease.
The firm saw strong growth in respiratory illness assays and lead testing, which was offset by a decline in C. difficile testing.
The miniature analyzer, which uses disposable cartridges that include all necessary reagents, is designed to provide results from one drop of blood.
The company is in discussions with the FDA about a new test being developed for severe bacterial pneumonia and expects to start a clinical trial in Q1 2019.
The platform, which Waters introduced last month, uses flow-injection tandem mass spectrometry to enable high-throughput analysis of dried blood spots.
Under the five-year agreement extension, Quest will continue to provide broad access to Clinical Genomics's InSure One fecal immunochemical test in the US.
The cleared system enables testing on a postage stamp-size piece of film along with advanced optics for precise results, Ortho said.
The association is concerned that waived testing sites are operating with insufficient oversight and compromising patient safety, and is asking Congress to investigate.
The new factory will be the company’s first in vitro diagnostic reagent plant in the Asia Pacific region, producing clinical chemistry and immunoassay reagents.
Molecular diagnostics revenues rose 5 percent driven in part by growth in infectious disease testing, a core area of diagnostic market focus for the firm.
The investment bank expects Abbott's Diagnostic division to grow in the mid-single digits driven in part by global launches of its Alinity systems.
The new building will serve as a hub for ARUP's lab campus, handling processing of new specimen as well as high-volume testing.