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 one, is still plowing full steam ahead in its testing and tracking efforts.
The genomic sequencing company nabbed an FDA emergency use authorization last July for its COVID test, which is analyzed in Helix’s own lab and, with an expanded EUA issued in October, can be used with nasal swab samples taken by individuals at home.
Spun off from Illumina in 2015, Helix has also teamed up with that sequencing giant to build a COVID-19 surveillance dashboard, with additional support from the U.S. Centers for Disease Control and Prevention.
The dashboard uses Helix and Illumina’s sequencing technologies to analyze COVID test results from across the U.S. to pinpoint the arrival of new virus variants and track their spread. The project has been broadly successful, with the system responsible for detecting a sizable number of cases of the U.K. strain that has since become the most prevalent variant in the U.S.
Far from slowing down as the U.S. positivity rate dwindles, these COVID testing and tracking efforts will instead get a major boost from Helix’s latest funding round.
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The $50 million series C was co-led by Warburg Pincus, DFJ Growth, Kleiner Perkins Caufield Byers, Mayo Clinic and Temasek, all of which have previously invested in Helix.
The financing follows (and is massively dwarfed by) the company’s monster-sized series B, which brought in $200 million in 2018 to expand Helix’s DNA testing “app store,” where customers can buy third-party DNA analysis products powered by Helix’s sequencing technology.
Since then, however, Helix has moved away from direct-to-consumer testing—though it still offers a handful of personal DNA tests—to focus instead on providing whole exome sequencing for life sciences companies and health systems. The series C funding will help speed up this shift from personal to population genomics.
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The Helix Laboratory Platform became in January the first whole exome sequencing platform to receive De Novo authorization from the FDA. It centers on Helix’s Exome+ assay, which uses a saliva sample to analyze approximately 20,000 genes. The platform uses the analysis to build a genomic profile that is securely stored for future testing, eliminating the need for repeated sample collection.
Along with the platform’s authorization, the FDA also granted Helix 510(k) clearance for use of its Genetic Health Risk App to measure a person’s risk of developing late-onset Alzheimer’s disease based on their genetic results.
The latest round of funding will help Helix develop even more Genetic Health Risk App tests that use the Helix Laboratory Platform’s analyses. Those could include tests for cancer and cardiovascular disease, as well as carrier screening, James Lu, Helix’s co-founder and CEO, said in a statement.
As Helix continues to expand its sequencing offerings, those test results and the stored genomic profiles can be accessed on an as-needed basis by health systems and life sciences companies to support their research and development work.