The infectious disease testing firm has developed a sequencing-based coronavirus assay, which it plans to commercialize through its sister firm BioID Genomics.
The diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
The firm believes that its molecular assay for the laboratory will help ease some of the supply chain issues hampering test rollout during the pandemic.
The agency compiled the evolving list by drawing on information from drug labeling and the published literature and is asking stakeholders to provide feedback.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
