Close Menu

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.

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

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.

The new test increases the multiplexing of the sepsis panel from 26 targets to 43 targets, including seven additional resistance genes.

Pages

President Donald Trump announced the US would be leaving the World Health Organization, NBC News reports.

A study of Great Danes homes in on a genomic region linked to fearfulness.

CDC head says a new analysis indicates earlier testing wouldn't have caught viral spread, NPR reports.

In PLOS this week: gene expression and epigenetics of Indonesian populations, hookworm parasite secretome, and more.