PALO ALTO, Calif. - Guardant Health , Inc. (NASDAQ: NASDAQ:GH), a precision oncology company, has revealed that its blood test, ShieldTM, shows promising results in detecting colorectal cancer (CRC) among average-risk adults. The findings from the ECLIPSE study are set to be published in The New England Journal of Medicine on March 14.
The study, which evaluated over 20,000 patients, demonstrated that the Shield test had an 83% sensitivity in identifying individuals with CRC and a specificity of 90%. The sensitivity was particularly high for detecting early-stage cancers, with 100% for stages II and III, and 65% for pathology-confirmed Stage I.
The performance of Shield is comparable to other non-invasive screening methods, which have overall sensitivity rates ranging from 74% to 92%. These results suggest the potential of the Shield test to serve as a convenient alternative to traditional screening methods, such as colonoscopy or stool-based tests, which some patients find invasive or unpleasant.
Following these findings, Guardant Health submitted a premarket approval application to the U.S. Food and Drug Administration (FDA) for Shield. Since its lab-developed version's launch in May 2022, the test has been completed by over 20,000 individuals, with a completion rate exceeding 90% among patients who were prescribed the test in real-world clinical settings.
The publication of the ECLIPSE study and the FDA submission mark significant steps toward the potential approval of the first blood-based screening test for CRC that could meet Medicare coverage requirements.
Colorectal cancer is the second-leading cause of cancer deaths in the U.S. The American Cancer Society estimates that in 2024, over 150,000 new CRC cases will be diagnosed. Early detection is vital, as the 5-year relative survival rate is 91% when detected early, compared to 13% if it has spread to distant parts of the body.
Guardant Health aims to improve CRC screening rates, particularly among the over 50 million Americans who are not up to date with recommended screenings. The ECLIPSE study's results indicate that the Shield test could help increase early detection rates, offering a significant advancement in the fight against colorectal cancer.
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