January 11, 2021
Helix has received de novo authorization from the U.S. Food & Drug Administration (FDA) for the Helix® Laboratory Platform, a whole exome sequencing platform with coverage of approximately 20,000 genes.
Helix advises this marks the first time such a broad, sequencing-based device has been authorized by the FDA. Additionally, Helix also received 510(k) clearance for the Helix® Genetic Health Risk App for late-onset Alzheimer’s Disease for over-the-counter use on the Helix Laboratory Platform.
Helix is excited to have collaborated with the FDA to pioneer a new regulatory pathway for a Whole Exome Sequencing Constituent Device (Regulation 21 CFR 866.6000) through the de novo authorization of the Helix Laboratory Platform. The analytical validation of the sequencing platform was conducted using a novel representative sampling-based approach in conjunction with rigorous quality metrics to establish the accuracy and reproducibility of the device.
This landmark market authorization of both a platform and its first test creates a defined regulatory path forward for Helix’s Sequence Once, Query OftenTM model. This enables Helix and its partners to develop and obtain market authorization for future tests using subsets of sequencing data generated from the Helix Laboratory Platform, including for cancer, cardiovascular disease, and carrier screening.
“Being the first company to receive market authorization for such a broad, sequencing-based platform is a major milestone for Helix and for the genomics industry,” said Dr. James Lu, M.D., Ph.D., co-founder, and President of Helix. “Our research has shown that many people are at risk for highly actionable genetic conditions that could be prevented with better access to genetic screening. This first-of-its-kind market authorization will greatly accelerate the adoption of genomic medicine that can personalize and improve the care that patients receive.”
“This is a very important milestone and highlights the growing role of genomics in clinical care,” said Francis deSouza, Illumina’s President and Chief Executive Officer. “We congratulate Helix on this authorization, which moves us another step closer to ensuring people have access to genomic insights that can transform their lives.”
“This tremendous collaboration with the FDA has allowed Helix to innovate a first-of-its-kind whole exome sequencing platform that will have a measurable impact on the ability to clear new genomic applications,” said Marc Stapley, Chief Executive Officer of Helix. “We are excited to have pioneered this new regulatory authorization pathway to help health systems, life sciences companies, and payers to accelerate the advancement of genomic discoveries from bench to bedside.”