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BioWorld - Monday, May 16, 2022
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Home » Helix scores first FDA authorization for whole exome sequencing platform
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Helix scores first FDA authorization for whole exome sequencing platform

Jan. 12, 2021
By Mary Ellen Schneider
No Comments
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.
BioWorld MedTech Regulatory Neurology/Psychiatric Diagnostics Genomics 510(k) De novo FDA

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