Helix Laboratory Platform Granted the First and Only FDA Authorization for a Whole Exome Sequencing Platform – PRNewswire

"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 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."

Learn more at helix.com/FDA.

About the Helix Laboratory Platform & theHelix Genetic Health Risk App

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 samples collected with OrageneDx OGD-610. The Helix Laboratory Platform is only intended for use with other devices that are germline assays authorized by FDA for use with this device. The device is performed at the Helix laboratory in San Diego, CA.

TheHelix Genetic Health Risk App uses qualitative genotypingto detect clinically relevant variants in genomic DNA isolated from human saliva collected from individuals 18 years with OrageneDx OGD-610 for the purpose of reporting and interpreting Genetic Health Risks (GHR): The Helix Genetic Health Risk App (HRA) for late-onset Alzheimer's disease is indicated for reporting of the e2/e2, e2/e3, e3/e3, e2/e4, e3/e4 and e4/e4 genotypes in the APOE gene. The report describes if a person's genetic result is associated with an increased or decreased risk of developing late-onset Alzheimer's disease. The e2 and e4 variants included in this report are found and have been studied in many ethnicities. Detailed risk estimates have been studied the most in people of European descent. The Helix Genetic Health Risk App (HRA) is to be used with the Helix Laboratory Platform.

About Helix

Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world's largest CLIA / CAP next-generation sequencing labs and the first and only FDA authorized whole exome sequencing platform, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employers, governments, and other organizations across the country. Learn more at http://www.helix.com.

Media Contact Amy Fisher, Padilla for Helix [emailprotected] 612.805.5707

SOURCE Helix

http://www.helix.com

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Helix Laboratory Platform Granted the First and Only FDA Authorization for a Whole Exome Sequencing Platform - PRNewswire