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FDA submission

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 company, known for clinical chemistry and molecular biology diagnostic kits, is currently working on two test kits for SARS-CoV-2.

The firm shipped research-use-only tests last week to key customers to validate the assay design using clinical samples.

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.

The company said it expects to launch the Verigene II system with respiratory and gastrointestinal assays in the middle of this year.

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.

The company's Curian immunoassay instrument is currently in front of the FDA, and the PediaStat will likely be submitted later this year.

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