Guardant Health COSMOS Study Published in Clinical Cancer Research Validates Utility of Guardant Reveal™ Liquid Biopsy Test for Predicting Recurrence in Colorectal Cancer
- Largest study to date evaluating MRD detection using tissue-free approach demonstrates 81% longitudinal sensitivity for recurrence in stage II or higher colon cancer
- Data demonstrate potential clinical utility of ctDNA as tool to improve management of stage II and higher CRC that allows for rapid evaluation without complexity of prior tissue analysis
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
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
The study will be published at
About Guardant Reveal
The first tissue-free test for minimal residual disease (MRD) detection in colorectal cancer, Guardant Reveal is also available for breast and lung cancers. Requiring only a simple blood draw, the test interrogates thousands of epigenomic signals to precisely quantify tumor fraction, offering sensitive and specific MRD results in under 10 days to inform timely clinical decisions in the post-surgery and surveillance settings in early-stage cancer. Guardant Reveal is a Laboratory Developed Test (LDT) with performance characteristics determined by the
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended
References
1. Nakamura Y, Tsukada Y, Matsuhashi N, et al. Colorectal cancer recurrence prediction using a tissue-free epigenomic minimal residual disease assay.
2. Samples were collected at day 28 and every 3 to 6 months post-operatively for up to five years or until clinical recurrence.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240807656024/en/
Investor Contact:
investors@guardanthealth.com
Media Contact:
press@guardanthealth.com
+1 317-371-0035
Source: