DiaSorin got the nod for the Liaison Lyme Total Antibody Plus assay which uses chemiluminescence to detect lgG and IgM antibodies to Borrelia burgdorferi.
The company announced Monday that it has inked a contract to become the primary supplier of products for immunoassay testing to Quest Diagnostics.
The FDA-cleared and CE-marked assay detects both fentanyl and norfentanyl, allowing labs to identify more true positives, according to Siemens.
The company's newest products and planned updates reveal a focus on operational efficiency and increasing automation for core lab management.
In one of two clearances, Beckman Coulter got the go-ahead to market its Access PCT chemiluminescent immunoassay for measuring levels of procalcitonin.
The agreement gives Quanterix an opportunity to explore the clinical utility of its Nf-l marker without having to move its instruments into the clinical space.
In one of two clearances in October, DiaSorin got the nod to market its Liaison XL Zika Capture IgM II test for the detection of Zika virus IgM antibodies.
The company's Liaison XL Zika assay previously received Emergency Use Authorization from the FDA in 2017.
Siemens Healthineers will use the technology, which Quanterix acquired as part of its buy of UmanDiagnostics, to develop blood-based Nf-L clinical tests.
The firm said it is tackling challenges in its Diagnostics business, which had 2 percent growth year over year on a comparable basis in its fiscal fourth quarter.