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The FDA also reissued Emergency Use Authorizations for SARS-CoV-2 tests from Roche and Express Gene to reflect their permitted use with additional sample types.
The advent of high-throughput antigen testing is especially timely as global regions are suffering second and third waves of infections during the coronavirus pandemic, Ortho said.
The new consortium is aiming to make comprehensive genomic profiling accessible to advanced cancer patients in the US, to help inform their treatment decisions.
Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.
The ratio of IL-6 to IL-10 biomarkers might give clinicians insight into how severe the inflammatory response to SARS-CoV-2 could be in certain patients.
The company has plans to launch another SARS-CoV-2 antigen test, as well as an immunoassay to detect Epstein-Barr virus in the fourth quarter.
MDx revenues grew 67 percent while centralized and POC solutions revenues were down 13 percent, tissue Dx slid 1 percent and diabetes care declined 10 percent.
Fujirebio Diagnostics got the nod for a chemiluminescent enzyme immunoassay to measure levels of CA 15-3 and manage patients diagnosed with breast cancer.
Semi-quantitative SARS-CoV-2 serology tests enable users to measure levels of neutralizing antibodies, but tests need to be more comparable across manufacturers, Siemens said.
If the lateral flow assay receives US regulatory approval, it would be the first antigen test for use in both symptomatic and asymptomatic individuals.