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Home » Keywords » Helix Opco LLC

Items Tagged with 'Helix Opco LLC'

ARTICLES

Helix lab

Helix scores first FDA authorization for whole exome sequencing platform

Jan. 12, 2021
By Mary Ellen Schneider
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. The San Mateo, Calif.-based company also picked up 510(k) clearance from the FDA for the first test to run on the Helix Laboratory Platform, a genetic health risk application for late-onset Alzheimer’s disease. That test has been cleared for over-the-counter use in conjunction with the Helix Laboratory Platform.
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Helix employee in lab with testing tubes

Expanded EUA positions Helix COVID-19 test as major gamechanger

Oct. 27, 2020
By Annette Boyle
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 and testing of asymptomatic individuals. The new indications promise to make the Helix test the preferred tool for schools, universities, and work settings by reducing costs and increasing flexibility.
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