Guardant Health COSMOS Study Published in Clinical Cancer Research Validates Utility of Guardant Reveal Liquid Biopsy Test for Predicting Recurrence in Colorectal Cancer

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced Clinical Cancer Research, a journal of the American Association for Cancer Research, will publish results today from the COSMOS study confirming the high sensitivity and specificity of the Guardant Reveal blood test in predicting recurrence of colorectal cancer (CRC).

The COSMOS (COnquer Solid Malignancies by blOod Screening) study is the largest study to date evaluating minimal residual disease (MRD) detection using a tissue-free epigenomic approach with the Guardant Reveal test.¹ The study assessed more than 1,900 longitudinal surveillance samples from 342 patients with clinical stage I-III resected CRC.² The study results demonstrated that detection of MRD using the Guardant Reveal test was associated with statistically significant and clinically relevant recurrence prediction at each post-surgical timepoint evaluated for patients with stage II or higher CRC.

“In the COSMOS study, we observed sensitive and specific detection of minimal residual disease in resected colorectal cancer using the Guardant Reveal tissue-agnostic epigenomic-based ctDNA assay,” said Yoshiaki Nakamura, M.D., Ph.D., chief, International Research Promotion Office, Department of Gastroenterology and Gastrointestinal Oncology at National Cancer Hospital East in Chiba, Japan, and a co-lead author of the study. “The use of a tissue-free assay offers healthcare systems significant logistical advantages by reducing the burden of tissue handling, as well as a shorter initial turnaround time for the result during the adjuvant decision-making window, while maintaining overall longitudinal performance comparable to previously reported tissue-informed approaches.”

Key study findings include:

• 100% of patients were able to undergo evaluation without the need for tissue testing
• 98% specificity in samples from patients without recurrence
• 81% longitudinal sensitivity for recurrence in stage II or higher colon cancer
• 5.3-month median lead time from ctDNA detection to recurrence

“Studies have established an association between the presence of residual disease after surgery and a higher probability of recurrence in early-stage colon cancer,” said Craig Eagle, M.D., Guardant Health chief medical officer. “The COSMOS study provides strong support for the use of the Guardant Reveal test to help inform adjuvant therapy decisions for patients with stage II or III colon cancer and, in post-treatment surveillance, to detect recurrence earlier than standard of care.”