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Results from a new patient cohort consistent with previously reported data
REDWOOD CITY, Calif., June 22, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (GH), a leading precision oncology company, presents new data at the American Association for Cancer Research (AACR) Virtual Annual Meeting II demonstrating that its LUNAR-2 liquid biopsy is a highly sensitive test that can detect early-stage colorectal cancer (CRC).
The data presented show that the LUNAR-2 assay achieved 90% sensitivity and 94% specificity in detecting early-stage CRC.1 When restricting analysis of the controls to those who were negative for CRC by colonoscopy (n=74), the LUNAR-2 assay demonstrated improved specificity (99%) with no reduction in sensitivity. These results are consistent with previously reported data2 showing that the company’s multi-modal, cancer-specific circulating tumor DNA (ctDNA) technology increases test sensitivity to deliver clinically meaningful results.
“Colorectal cancer remains a leading cause of cancer-related death, yet it is estimated that nearly 1 in 3 American adults are not up to date with screening recommendations despite the availability of colonoscopies and stool-based testing. Our LUNAR-2 assay holds the promise to directly improve cancer screening rates by addressing patient non-compliance with a simple blood test. This study confirms that our test can consistently detect early-stage colorectal cancer,” said Dr. Kathryn Lang, Guardant Health Vice President of Outcomes and Evidence. “Additionally, in light of COVID-19 and the associated challenges of performing invasive procedures, the need for highly sensitive screening tests that are easy to administer are more important than ever.”
The LUNAR-2 assay is currently being evaluated in a large-scale, registrational trial, ECLIPSE (NCT04136002), to detect CRC in average-risk adults.
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets, and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential benefits and advantages of Guardant Health’s LUNAR-2 assay, 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. Such risks and uncertainties include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the period ended March 31, 2020, and in its other reports filed with the Securities and Exchange Commission. These forward-looking statements are based on current expectations, forecasts, assumptions and information available to Guardant Health as of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.
Westesson O, Axelrod, H, Dean J, et al. Integrated genomic and epigenomic cell-free DNA (cfDNA) analysis for the detection of early-stage colorectal cancer (CRC). Poster presented at AACR Virtual Annual Meeting II, June 22-24, 2020.
Kim ST, Raymond VM, Park JO, et al. Combined genomic and epigenomic assessment of cell-free circulating tumour DNA (ctDNA) improves assay sensitivity in early stage colorectal cancer (CRC). Proceedings: AACR Annual Meeting 2019; March 29-April 3, 2019; Atlanta, GA, DOI: 10.1158/1538-7445.AM2019-91