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While many makers of COVID-19 diagnostics have reeled in their once-lofty projections for test sales this year—thanks to the widespread and growing availability of the coronavirus vaccines—Helix, for ...

The FDA has given genomics firm Helix a wider emergency use authorization (EUA) for its pandemic test. The U.S. regulator said Helix is now allowed to offer its virus test for on-site and unsupervised ...

The U.S. FDA moved the goal posts for other companies with its expansion of the emergency use authorization for Helix Opco LLC’s COVID-19 test to include both unsupervised self-collection of samples ...

Helix Opco LLC, a company specializing in population genomics, has received de novo marketing authorization from the U.S. FDA for its whole exome sequencing platform, which covers roughly 20,000 genes ...