FDA grants authorization for whole exome sequencing platform from Helix

Jan. 12, 2021

Helix, which specializes in population genomics, announced it has received de novo authorization from the U.S. Food and Drug Administration (FDA) for the Helix Laboratory Platform, a whole exome sequencing platform with coverage of approximately 20,000 genes, according to a press release from Helix.

Helix contended that this is the first time a broad, sequencing-based device has been authorized by the FDA. In addition, Helix received 510(k) clearance from the FDA for an over-the-counter test to assess genetic risk for late-onset Alzheimer’s disease. Called the Helix Genetic Health Risk App for late-onset Alzheimer’s disease, it runs on the Helix Laboratory Platform.

The analytical validation of the sequencing platform was conducted using a novel representative sampling-based approach in conjunction with quality metrics to establish accuracy and reproducibility of the device. Helix and its partners envision developing and obtaining market authorization for future tests using subsets of sequencing data generated from the Helix Laboratory Platform, including for cancer, cardiovascular disease, and carrier screening, according to the company’s news release.

The Helix Laboratory Platform is a qualitative in vitro diagnostic device intended for exome sequencing and detection of single nucleotide variants (SNVs) and small insertions and deletions (indels) in human genomic DNA extracted from saliva. The testing is performed at the Helix laboratory in San Diego, CA.

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