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To enable the use of saliva in addition to other types of samples, Sysmex requested a change to a marketing approval it obtained in March.
Avalon said it intends to establish a facility in the US for the manufacture and assembly of antibody and PCR-based detection systems.
The company said it has scaled up production capacity to two million reactions per week and has the potential to scale up to three million reactions per week.
The new method uses Takara Bio's SmartChip PCR instrument, chips, and reagents to run 5,184 reactions per chip in less than 30 minutes.
The test uses a proprietary at-home PCR nasal swab test with a turnaround time of 24 hours and is authorized for use by at-risk people.
The findings suggested recovered patients could still be viral carriers and might benefit from further monitoring after their release from the hospital.
During evaluations of 180 randomized specimens, the Genedrive 96 SARS-CoV-2 Kit achieved 100 percent sensitivity and 98.2 percent specificity, the firm said.
The RT-PCR test targets the N gene and E gene regions of the SARS-CoV-2 genome in a multiplex format.
The PCR-based test works with upper and lower respiratory specimens, including nasal swabs and sputum, and can be performed by high complexity labs.
The company's Linea COVID-19 assay kit is a high-sensitivity real-time, reverse-transcriptase PCR-based assay to detect target sequences of the SARS-CoV-2 Spike gene.
The FDA and CDC call for a pause in administering Johnson & Johnson's SARS-CoV-2 vaccine while reports of rare blood clots are looked into, reports the Wall Street Journal.
According to the Associated Press, a Swiss program aims to shepherd long-term science projects and diplomacy.
CNN reports that two new studies suggest the B.1.1.7 SARS-CoV-2 variant may be more transmissible, but may not lead to more severe disease.
In PNAS this week: analysis of pathway affecting acute kidney injury, parental-specific allelic expression in horse placenta, and more.