Abbott is accused of infringing IP related to a method for detecting HIV-2 antibodies and of violating the terms of a licensing deal related to the patent.
Gencurix's assay can be used to select which non-small cell lung cancer patients will respond to tyrosine kinase inhibitors.
The PCR-based test can simultaneously detect for the Zika virus, all serotypes of the dengue virus, the chikungunya virus, the West Nile virus, and a host gene.
The sales decline was largely due to a slowdown in productivity related to the recent launch of the company's global enterprise resource planning system in Western Europe.
Bio-Rad said that the Visia platform offers a standardized and automated workflow needed by laboratories to handle ever-increasing immunofluorescence workloads.
The control, being launched for the immunoassay-based tumor marker testing space, features HE4 and HER-2/neu, and outside the US, proGRP and SCC.
The multiplexed panel detects IgM class antibodies to Toxoplasma gondii, rubella, and cytomegalovirus that are associated with congenital diseases.
The firm said the automated assay offers labor savings and improved workflow for labs compared to traditional manual testing methods.
The test, which detects DNA methylation markers, is being developed as an alternative to invasive cystoscopy, the current standard of care.
The agency cleared a handful of assays last month for the detection and diagnoses of toxoplasmosis, syphilis, sepsis, thyroid conditions, and other ailments.