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 Access PCT assay can help clinicians assess patients in danger of severe sepsis or septic shock and delivers results in less than 20 minutes.
In one of two clearances, Beckman Coulter got the go-ahead to market its Access PCT chemiluminescent immunoassay for measuring levels of procalcitonin.
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 said it plans to move all its immunoassays to a single vendor, representing an opportunity worth between $250 million and $400 million annually.
The company received an initial $1.25 million and could receive another $6.5 million to develop and commercialize a machine-learning-based sepsis detection algorithm.
The company's life sciences revenues were up 6 percent while its diagnostics business grew almost 7 percent.
The FDA gave the nod to Shenzhen Bioeasy Biotechnology for two lateral flow immunoassays that provide preliminary results in detecting marijuana in urine.
The system, which was launched in Europe earlier this year, helps eliminate preanalytical errors by automatically detecting patient tube parameters.
Sysmex alleges multiple Beckman Coulter analyzers of infringing two patents covering technology for sensing blood or fluid samples.