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Ravgen has alleged that several leading NGS-based non-invasive prenatal testing and oncology assays infringe two patents held by the firm.
Test capacity, particularly for rapid antigen testing, is set to explode in Q1 2021, but home and asymptomatic assays remain few and far between.
The FDA last week also reissued an EUA for a PCR-based SARS-CoV-2 test from Quest Diagnostics to permit its use with pooled samples.
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.