Guardant Health Demonstrates ShieldTM Blood Test’s Efficacy in Detecting Colorectal Cancer

Precision oncology company, Guardant Health (Nasdaq: GH) has published results from its ECLIPSE study showing the effectiveness of its ShieldTM blood test for detecting colorectal cancer (CRC) in the March 14 issue of The New England Journal of Medicine. Guardant’s registrational study is one of the largest of its kind, and will enroll more than 20,000 patients to evaluate the performance of Shield compared to a screening colonoscopy.

“Over 50 million eligible Americans do not get recommended screenings for colorectal cancer, partly because current screening methods are inconvenient or unpleasant,” said AmirAli Talasaz, Guardant Health co-CEO. “We believe the publication of the ECLIPSE study in The New England Journal of Medicine, one of the world’s leading medical journals, is an endorsement of the quality of our clinical data and the potential value of the Shield test. We are confident that offering an accurate blood test has the potential to significantly reduce preventable colorectal cancer deaths.”

The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA).

Highlights

In Guardant’s study, the Shield test demonstrated 83% sensitivity in detecting individuals with CRC and 88% sensitivity in detecting pathology-confirmed Stages I-III.

Guardant has submitted an application for premarket approval (PMA) to the FDA.

The Shield test for colorectal cancer screening is commercially available for eligible individuals by prescription only through healthcare professionals.

More than 75% of people who die from CRC are not up to date with recommended screening, often due to the perception that current methods such as colonoscopy or stool-based tests are invasive, time-consuming and inconvenient.

About Guardant Health

Guardant Health is a leading precision medicine company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

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Guardant Health Demonstrates ShieldTM Blood Test’s Efficacy in Detecting Colorectal Cancer

Catie Corcoran

Biotech Editor