The test can now be used to identify triple-negative breast cancer patients who are likely to benefit from the immunotherapy Tecentriq plus chemotherapy.
BioMérieux received clearance for its Vitek 2 gram-negative susceptibility card as a test used to determine the antimicrobial susceptibility of certain aerobic bacilli.
The British molecular diagnostics firm recently completely a redesign of its point-of-care system, called Q-POC, and is planning to seek a CE-IVD mark for the device later this year.
The Polish company recently received 9 million Polish złoty ($2.4 million) from the country's National Center for Research and Development to support its activities.
The FDA said that Terrific Care/Medex Supply distributed certain Roche Diagnostics test strip lots in the US even though domestic sales had been stopped due to safety concerns.
Roche Diagnostics had sales of CHF 12.88 billion in 2018. For the fourth quarter, diagnostics sales totaled CHF 3.5 billion, up 10 percent year over year.
Roche plans to establish a CAP/CLIA-certified protocol for the assay and PhoenixMD will further refine its precision for identifying patients who may benefit from its RSK2 inhibitor.
The issue, discovered in late October, affected TMB reporting for up to 800 FoundationOne CDx tests during a short period of time and was quickly resolved.
