CareDx Supports Vir Biotechnology’s Clinical Trial Recruitment Efforts for COMET-ICE

Rhea-AI Summary

CareDx, Inc. (Nasdaq: CDNA) announced efforts to raise awareness for Vir Biotechnology’s COMET-ICE study, evaluating the monoclonal antibody VIR-7831 for early COVID-19 treatment in high-risk adults. The trial, which focuses on the immune-compromised transplant patient population, was halted for enrollment following recommendations from an Independent Data Monitoring Committee due to significant efficacy. CareDx aims to facilitate patient access to clinical trials, providing additional treatment options beyond vaccines for vulnerable transplant patients.

Positive

• CareDx's initiative to promote the COMET-ICE study for VIR-7831 could enhance its reputation in the transplant community.
• Stopping enrollment in the trial due to evidence of profound efficacy indicates strong potential effectiveness of the treatment.

Negative

• None.

Effort underscores CareDx’s commitment to the transplant community

SOUTH SAN FRANCISCO, Calif., March 23, 2021 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced details of their effort to raise awareness and identify potential transplant patients for participation in Vir Biotechnology’s COMET-ICE study (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early).

The ongoing trial is evaluating VIR-7831, a fully human anti-SARS-CoV-2 monoclonal antibody, for the early treatment of COVID-19 in adults at high risk of hospitalization. CareDx’s existing relationships at transplant centers in the U.S. helped raise awareness and identify potential study participants from this high-risk, immune-compromised population. On March 10, 2021, an Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy.

“We appreciated CareDx’s efforts in raising awareness about this study at our center. Transplant recipients are generally on life-long immunosuppressive medications, and it is imperative to validate therapeutic strategies that could reduce the risk of severe disease-related clinical outcomes in this vulnerable population,” said Dr. Jay Graham, Transplant Surgeon, Montefiore Medical Center.

“CareDx is constantly looking for ways to provide value to the transplant community. We felt it was our duty to let the doctors serving transplant patients know about the clinical trial and to help facilitate access for patients,” said Sham Dholakia, SVP Medical Affairs, CareDx. “Helping to provide optionality, exploring how immunoglobulin can protect immunocompromised patients, in addition to vaccines, will help further reduce the impact of COVID-19.”

About CareDx

CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.

Forward Looking Statements

This press release includes forward-looking statements, including statements regarding the Company’s acquisition of BFS Molecular and the potential benefits and results that may be achieved through the acquisition. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed by CareDx with the SEC on February 24, 2021 and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

CONTACTS:
CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@caredx.com

Investor Relations
Greg Chodaczek
347-610-7010
investor@caredx.com

FAQ

What is the purpose of the COMET-ICE study involving CDNA?

The COMET-ICE study aims to evaluate the efficacy of the monoclonal antibody VIR-7831 for early COVID-19 treatment in adults at high risk of hospitalization.

What does CareDx's involvement in the COMET-ICE trial mean for transplant patients?

CareDx's efforts help identify and raise awareness among transplant patients, facilitating their participation in a trial that could benefit this vulnerable group.

What were the results of the Independent Data Monitoring Committee's review of the COMET-ICE trial?

The committee recommended halting enrollment in the trial due to evidence of profound efficacy of the treatment.

How does CareDx plan to support transplant patients during the COVID-19 pandemic?

CareDx is actively promoting clinical trial participation and exploring therapeutic options, including monoclonal antibodies, to reduce the risk of severe COVID-19 outcomes in transplant patients.