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The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.
Some insiders emphasize the importance of doing rapid turnaround testing of asymptomatic people, while others contend lab tests ought to be the modality of choice.
The reissued Emergency Use Authorization from the US Food and Drug Administration also permits the test's use in asymptomatic individuals, the firm said.
The in vitro diagnostic test runs on the Illumina NovaSeq 6000 instrument and will be performed at Helix's San Diego CLIA-certified laboratory.
The sequencing firm said infectious disease research, diagnostics, screening, and surveillance could all increase demand for its NGS products.
The seven technologies feature different methods, including CRISPR and microfluidics, and can be performed in many settings and with a variety of sample types.
A number of diagnostic labs have considered saliva-based SARS-CoV-2 testing but decided against it, while other groups continue to pursue it.
Both PCR-based tests are designed to detect the SARS-CoV-2 nucleocapsid and ORF1ab genes, while Helix's assay also detects the virus' spike protein gene.
The population genomics firm said that it can provide 2,000 COVID-19 PCR tests per day out of its San Diego lab while it awaits FDA Emergency Use Authorization.
Several groups are developing diagnostic viral genome sequencing assays and panels, which promise high sensitivity and additional information on viral origin and spread.