Guardant Health presents additional information from ECLIPSE study at 2023 Digestive Disease Week on the performance of Shield blood test

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today presented additional data from the ECLIPSE study at 2023 Digestive Disease Week (DDW) titled, “Clinical Validation of a Cell-Free DNA Blood-Based Test for Colorectal Cancer in an Average Risk Population” (Abstract #913e) showcasing the performance of its blood-based technology to accurately detect early-stage colorectal cancer (CRC).

The ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode) study is an over 20,000 patient registrational study evaluating the performance of the Shield blood test for detecting CRC in average-risk adults. The data presented at DDW elaborates on the top-line data the company announced in December 2022. Data presented today include:

• 83% sensitivity in detecting individuals with CRC;
• 81% sensitivity in detecting Stages I-III;
• 72% sensitivity in detecting localized disease (Stage I-II); and
• Sensitivity by stage of 55% for Stage I, 100% for Stage II, 100% for Stage III, and 100% for Stage IV.

These results are in range with other guideline recommended non-invasive screening modalities, where overall sensitivity ranges from 74-92%.

The ability to detect cancers in early stages is an important test parameter as the five-year survival rate is higher when caught early.¹ Shield’s sensitivity of detecting stage I-III cases and localized cases (stage I-II) is in range with other guideline-recommended non-invasive screening modalities (FIT sensitivity in Stage I-III is 73%, and in localized cases is 70%).²

“There is a need for a more convenient and less invasive method to screen for colorectal cancer, and an accurate blood test has the potential to overcome many barriers patients face with traditional screening methods," said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. "The data presented today at DDW highlight the promising results for blood-based CRC screening and the potential for blood tests to help close the gap in screening adherence."

Colorectal cancer is the third leading cause of cancer related death, but it is highly preventable and treatable if caught early.³ Despite multiple screening modalities available for CRC, 49 million Americans remain unscreened.⁴ Screening rates are even lower in minority and underserved populations.⁵ This was a key consideration when conducting the ECLIPSE study, which reflects the diverse population of the U.S. Study data includes 13% Black, 15% Hispanic and 7% Asian American populations. Enrollment among Black Americans was above average for a clinical trial, which is important given the disproportionate impact of CRC on the black community.⁶