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Scripps Taps Cue for COVID Study

BIOTECH: Early Detection, Telehealth Could Help

For the over 7 million immunocompromised people in the U.S., contracting COVID is still a high-risk event that can result in a severe outcome.

To find ways to lessen the severity of contracting COVID and reducing hospitalizations from the disease, scientists at the Scripps Research Translational Institute have teamed up with San Diego-based healthcare technology company Cue Health to launch ImmunoCARE –  a remote trial program that provides study participants with a combination of fast and accurate molecular at-home tests to diagnose infection, on-demand telemedicine consultations, and same-day delivery of antivirals (if medically indicated) to treat COVID-19.

The study seeks to determine if early detection of infection and treatment can reduce hospitalizations and adverse outcomes in vulnerable populations.

Eric Topol, MD
Founder & Director
Scripps Research Translational Institute

“It’s taking too long to get help to the people who need it the most,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute and co-principal investigator of the study. “The continued evolution of the virus and its ability to escape our immune response has rendered monoclonal antibodies ineffective, making it all the more important for us to continue to innovate and develop tools to protect the immunocompromised and elderly.”

Immunocompromised individuals include people with autoimmune diseases, such as type 1 diabetes, rheumatoid arthritis and lupus. Other immunocompromised people suffer from conditions like HIV and AIDS that destroy immune cells. Additionally, medications such as immunosuppressive therapies taken by transplant recipients to keep their bodies from rejecting their new organs, can reduce immune function.

Julia Moore Vogel, Ph.D.
Program Director
Scripps Research Translational Institute
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“In many ways, the immunocompromised community is more at risk now than they were earlier in the pandemic,” said Julia Moore Vogel, Ph.D., co-principal investigator of ImmunoCARE and a program director at the Scripps Research Translational Institute. “We’re no longer seeing non-pharmaceutical interventions to prevent transmission, such as masking and isolating when exposed to COVID-19, being employed by a large proportion of the public, leaving immunocompromised people to fend for themselves. This study is our attempt to help this vulnerable group of people avoid severe outcomes.”

Leveraging Cue Platform

The ImmunoCARE study will provide half of the participants a Cue Reader and up to 10 COVID-19 cartridges every month for home testing of themselves and members of their households. Cue’s nucleic acid amplification tests detect the genomic RNA of SARS-CoV-2 and are much more sensitive than the more common over-the-counter rapid antigen tests for COVID-19.

The study seeks to determine whether early detection can reduce transmission within the household and enable early treatment when immunocompromised individuals test positive.

David Tsay, MD, Ph.D.
Chief Medical Officer
Cue Health

“This study, led by world-class researchers at Scripps Research, will provide pivotal data on whether access to highly accurate molecular at-home tests such as Cue’s COVID-19 test will facilitate earlier detection among high-risk individuals and lead to better health outcomes,” says David Tsay, MD, PhD, chief medical officer at Cue Health.

The ImmunoCARE program is based on Cue’s commercial platform, Cue Care, that the company officially launched in August of last year. Just like anyone who utilizes the Cue Care service, patients in the clinical study will have the same access to telehealth, e-prescription and prescription delivery services when medically necessary.

“We look forward to bringing our technology to some of the patients who are the most vulnerable to respiratory diseases, such as COVID-19. Particularly with the new XBB variants, certain treatment options are no longer effective for vulnerable populations like those who are immunocompromised, so there is a great clinical need to expand the treatment toolset for these patients,” Tsay said. “We’re excited to see how the Cue platform, which brings fast and accurate at-home testing, can enable early detection and subsequent treatment of COVID-19 for the immunocompromised, ultimately reducing adverse outcomes such as hospitalization.”

Tsay added that Cue is excited to work with Scripps because of the institute’s leadership in clinical research and decentralized virtual trials, “particularly the Scripps Digital Research Center has led the charge in previous COVID-19 research at scale, such as the DETECT study, which enrolled over 40,000 participants.”

“We want to participate in more clinical research like this,” he continued. “We strongly believe that diagnostic-led healthcare and fast and accurate molecular testing at home can empower patients to make healthier choices. Cue brings an advantage to this study by providing participants with the ability to diagnose themselves at home in a safe environment.”

To obtain the results of the ImmunoCARE study, scientists will compare infection rates, emergency department visits, ICU admissions, deaths and cost of care between the control and intervention groups by reviewing insurance claims data at the program’s conclusion.

In addition to utilizing Cue’s testing platform, the study will also leverage the MyDataHelps mobile app-based research platform developed by CareEvolution, a Michigan-based health technology company that enables secure and reliable sharing of clinical health information.

The ImmunoCARE study plans to enroll 10,000 immunocompromised participants nationwide.

Scripps Research

Founded: 1924
CEO: Peter Shultz
Business: Medical and scientific research institute
Headquarters: La Jolla
Employees: Over 2,400
Revenue: Over $500 million (2021)
Website: scripps.edu
Notable: According to the 2017  Nature  Innovation Index, Scripps Research is the No. 1 most influential research institution in the world.

Cue Health

Founded: 2010
CEO: Ayub Khattak
Headquarters: Sorrento Valley
Business: Health technology company that makes digital point-of-care testing solutions
Stock: NASDAQ: HLTH
Revenue: $600-625 million FY2021; $69.6 million Q32022
Employees: 1,500
Website: cuehealth.com
Notable: Cue Health was founded in 2010 during another respiratory viral outbreak – the swine flu.

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