SAN MATEO, Calif. and SAN DIEGO, Nov. 18, 2021 – Helix, a leading genomics company that provides nationwide viral surveillance of respiratory disease, and Cue Health Inc. a healthcare technology company, announced a new collaboration today to provide individuals who test positive on Cue's at-home molecular COVID-19 test the opportunity to learn which variant they have contracted as part of a broader research study on the SARS-CoV-2 virus.
Despite the growing availability of vaccines in the United States, the need for more consistent sequencing of the SARS-CoV-2 virus, and any future respiratory viruses, continues to be significant as more contagious strains like the Delta variant have resulted in new waves of infections. This collaboration further builds on Cue's previously announced real-time Variant Tracking and Sequencing Platform, which will utilize AI and ML from Google Cloud. Cue Health and Helix intend to roll out this new capability in the fourth quarter.
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 Ayub Khattak, CEO and co-founder of Cue Health.
"We are excited to work with Cue Health to support COVID-19 testing and surveillance in a range of settings, from consumer to clinic to community sites, and deliver those results at scale and with speed," said James Lu, M.D., Ph.D., CEO and Co-founder of Helix.
The Helix variant sequencing test is for Research Use Only and not yet authorized by the U.S. Food and Drug Administration (FDA) for health care. The sequencing result provided is for the user's information only and not to be used for medical decisions.
The United States has ranked 43rd in the world, in terms of overall sequences performed and shared, according to Global Initiative on Sharing All Influenza Data (GISAID). By collaborating, Helix and Cue Health can help address the need for faster sequencing results by together providing individuals with more comprehensive real-time access to their personal health information, while increasing researchers' awareness of known variant spread and new variants. This sequencing effort will also allow Cue Health to contribute to the public health sequencing efforts by uploading sequences to GISAID, which is the largest data sharing repository of SarS-COV-2 sequencing data, relied upon by researchers, public health entities, and others worldwide.
Cue Health's COVID-19 tests have been used by millions of people in thousands of settings where a highly accurate, no-compromise testing solution is required, including schools, nursing homes, correctional facilities, hospitals, and community health clinics, as well as in world-class organizations like Google, Mayo Clinic, NASA, the NBA, and MLB. Cue's COVID-19 test can be used on adults and children (2 years and over), with or without symptoms, wherever they are.
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 CDC and state-level departments of health. Helix also maintains a public viral surveillance dashboard on its website and has published over a dozen pre-print and peer-reviewed publications on viral sequences.
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.
About Cue Health
Cue Health (Nasdaq: HLTH) is a healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India's Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit www.cuehealth.com.
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, employees, governments, and other organizations across the country.
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 September 23, 2021 filed by Cue with the SEC. Any forward-looking statements contained in this press release are based on the current expectations of Cue's management team and speak only as of the date hereof, and Cue specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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.