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.
FDA officials said at ACLA's annual meeting that the agency's efforts to balance rapid test access with safety during the coronavirus crisis carries lessons for the oversight of all tests.
ARUP partnered with BioMarin to develop the blood-based assay, which is intended to identify those patients most likely to respond to the drug firm's AAV5-based gene therapy.
