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Mayo Clinic

The Chinese company said it would use some of the funding to advance its integrated diagnostics research and development pipeline.

The test uses isothermal nucleic acid amplification to return results in 20 minutes at the point of care, and demonstrated 98 percent agreement with PCR testing.

News items for the in vitro diagnostics industry for the week of Jan. 4, 2021.

Demand for SARS-CoV-2 testing sent lab revenues soaring while changes in patterns of patient care and regulations that could have impacts for years to come.

In a session on Monday, lab heads recounted struggles they faced ramping up testing and offered ideas for avoiding similar issues in the future.

At an AMP virtual meeting workshop, a Mayo Clinic lab director offered advice on what diseases to include, how to handle VUSs, and other considerations for ECS.

Sciex has discontinued the Topaz platform three years after its launch while Thermo Fisher aims to drive adoption of its Cascadion following a recent US launch.

The firm expects to launch a tissue-based immunohistochemistry version of the test, which detects QSOX1, in mid-2021, followed by a dipstick plasma-based assay by early 2022. 

Thermo Fisher will seek Emergency Use Authorization from the US FDA and international regulatory authorizations for the test over the next few weeks.

The PCR-based assay is designed to detect RNA from the virus' nucleocapsid and ORF1ab genes in upper and lower respiratory specimens.