Helix and Cue Health Collaborate to Provide Individuals with Access to their COVID-19 Variant Sequencing Information
Despite the growing availability of vaccines in
Cue users who receive a positive test result for COVID-19 will be able to opt-in to SARS-CoV-2 variant sequencing. After consenting to participate in this study, users will receive a same-day sample collection kit with a prepaid return shipper via Cue's last-mile delivery partners. The Cue Health App will guide users through a simple, lower nasal swab self-collection to obtain their sample for sequencing. Returned samples will arrive at Helix for immediate processing, and results from Helix will be shared with the individual through the Cue Health App within ten days. This fully integrated and connected workflow will help expedite sequencing information turnaround time, while providing those tested with insight about their role in pandemic response and containment.
"Cue's connected platform aims to empower people by providing them with fast and convenient access to their health information. Together with Helix, we can provide researchers with even more information about what type of viral strain a person might have, arming them with information to help prevent further viral spread within our communities," said
"We are excited to work with
The Helix variant sequencing test is for Research Use Only and not yet authorized by the
Helix quickly established itself as one of the largest and most capable labs in performing high-throughput diagnostic testing in the US. Since spring of this year, Helix has focused its efforts on viral surveillance in response to the need for more comprehensive and consistent viral sequencing. Helix has analyzed and reported on tens of thousands of COVID-19 viral sequences, sharing information with
The companies expect that the research study will contribute knowledge to help better understand pandemics and how they evolve so as to improve pandemic readiness now and into the future.
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 and viral surveillance system to meet the needs of health systems, employers, governments, and other organizations across the country. Learn more at www.helix.com.
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements". The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the "Risk Factors" section of the prospectus dated
The Cue COVID-19 Test for Home and Over the Counter (OTC) Use has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Helix, firstname.lastname@example.org, Cue Health, email@example.com