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Illumina, Helix Collaborate on CDC-Coordinated Coronavirus Surveillance

NEW YORK – Illumina and Helix announced Wednesday a collaboration to track the emergence and prevalence of SARS-CoV-2 strains in the US, including the novel, highly-transmissible variant B.1.1.7, first identified in the UK.

Under the terms of the collaboration, with support from the US Centers for Disease Control and Prevention (CDC), Helix will analyze positive samples with S gene dropout on their PCR-based COVID-19 assay. Illumina will then sequence a subset of these anonymized samples using its COVIDSeq test to determine whether the dropout is due to strain B.1.1.7 or a different mutation.

The partners have already identified 51 out of the first 54 cases of the B.1.1.7 variant reported in the US. Helix and Illumina are expanding the scope of their collaboration to examine a higher volume of samples on an ongoing basis for both the presence of B.1.1.7 and new strains.

The CDC is coordinating the program overall, especially the response to authorities in US states, an Illumina spokesperson said in an email.

Financial and other details of the collaboration were not disclosed.

"Having a robust surveillance effort in place is critical to understanding how the SARS-CoV-2 virus is evolving, and how our public health response needs to adapt," Helix Cofounder and President James Lu added in a statement. "By bringing together the strengths of Helix, Illumina, and the CDC, we were able to quickly evaluate the prevalence of this new variant and take learnings from this effort to better and more proactively characterize future strains that will emerge."

Launched in 2015 with investment from Illumina, Helix initially targeted the consumer genomics market with an "app store" business model but has recently focused on COVID-19 testing. It has received Emergency Use Authorization from the US Food and Drug Administration for both next-generation sequencing- and PCR-based COVID-19 assays and has received $33.4 million from the National Institutes of Health to address COVID-19 diagnostics. In July, the firm partnered with San Diego County to provide molecular testing.

In April 2019, Illumina relinquished its equity in Helix and seats on that firm's board.