Illumina received an emergency authorization from the FDA for its COVID-19 test designed to sequence the full genome of the novel coronavirus.
Using the company’s high-throughput NovaSeq 6000 hardware, the diagnostic COVIDSeq Test is capable of processing over 3,000 samples at once, taken from nasopharyngeal and oropharyngeal swabs. Results are provided within 24 hours.
“COVIDSeq leverages the performance of [next-generation sequencing] to help address the global need for diagnostic testing to fight the COVID-19 pandemic,” Illumina CEO Francis deSouza said in a statement.
“Beyond diagnostic testing, Illumina and a number of our customers are exploring NGS-based workflows to enable high-volume screening to support a return to work and school,” deSouza said.
The test targets and amplifies 98 different segments of the SARS-CoV-2 genome, which Illumina says gives the kit high accuracy and sensitivity. COVIDSeq will first be available to a limited number of sites before expanding over the summer, the company said.
In mid-March, Illumina partnered up with metagenomics company IDbyDNA to offer new workflows focused on the coronavirus and other infectious diseases—including a co-marketing agreement for the latter’s Explify platform, which runs on the sequencing giant’s hardware.
That includes a DNA-based diagnostic that can identify over 50,000 microorganisms and 3,000 pathogens in the clinic as well as potential resistance profiles to antimicrobial drugs.
By: Conor Hale
Source: Fierce Biotech
The Food and Drug Administration’s top scientist Namandjé Bumpus will assume the role of principal deputy commissioner when longtime agency leader Janet Woodcock retires from that role in early 2024, according to an announcement Thursday.
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EUROAPI today announced the appointment of David Seignolle as Chief Operating Officer, succeeding Eric Berger, and Marion Santin as Chief Legal, Compliance, and IP Officer, both joining the company’s Executive Committee. In his new role, David Seignolle will lead the transformation of the Industrial Operations organization.