The solutions are solutions for both clinical chemistry and immunoassay platforms and are meant to help labs run tests faster on less equipment and automate manual tasks.
Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies — IgG and IgM — to the hepatitis A virus.
New resistance tests for Mycoplasma genitalium and gonorrhea could help stave off superbugs, but guidelines and economic factors may hinder adoption.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.
A UPenn research team has developed a proof-of-principle detection platform that uses microbubbles to make target protein molecules visible and detectable.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
Siemens Healthineers received clearances for an assay used to detect and monitor acute pancreatitis, and for tests and controls used to detect Zika.
At the Henry Ford Health System in Southeast Michigan, bringing on the Roche Cobas Liat for flu testing led to a season of headaches before it started paying off.
In US influenza testing, providers see growth in placements within hospital emergency departments, physicians' offices, urgent care centers, and retail clinics.