Blood-based multimodal test achieved 100% sensitivity for colorectal cancer at 90% specificity in a prospective study of 557 individuals

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced data showing its blood-based multimodal test achieved clinically significant thresholds of sensitivity and specificity in detecting colorectal cancer (CRC). These data were presented during an oral presentation at Digestive Disease Week 2022.

The assay used in this analysis integrates genomics and epigenomics for CRC detection. An updated version of this assay that incorporates the use of proteomics, Shield™, is now available as a laboratory developed test for eligible individuals by prescription only through healthcare professionals.

“Colorectal cancer is curable if detected early, and yet many adults are not up to date with recommended colorectal screening. Offering eligible individuals a blood-based test could help overcome many barriers associated with currently available methods, such as a colonoscopy or a stool-based test,” said Paloma Peinado, MD, HM Hospitales, Madrid, Spain. “These data are the first from a prospective study to suggest that this blood-based multimodal test demonstrates the sensitivity and specificity needed to make it a screening option for colorectal cancer.”

The ongoing prospective observational study is being conducted at four hospitals in Spain. The data presented include 557 individuals who had a complete colonoscopy and results from the blood-based multimodal CRC test. The median age was 55 years (range 45-84 years; 21% age 45-49, 75% age 50-74, 4% age 75+), and 52% of the cohort was female. Sensitivity (detection rate) for colorectal cancer was determined at 90% and 95% specificity (true negative rate).

At 90% specificity the assay achieved 100% sensitivity (8/8; Stage I,1/1; Stage II,3/3; Stage III,2/2; Stage IV,2/2). At 95% specificity, the assay achieved sensitivity for CRC at 88% (7/8): Stage I (1/1), Stage II (2/3), Stage III (2/2), Stage IV (2/2).

“We are pleased to report these prospective data further illustrate the promise of our multimodal assay as a highly sensitive blood-based screening test for colorectal cancer,” said AmirAli Talasaz, Guardant Health co-CEO. “Though curable if caught early, colorectal cancer remains the third most common cancer worldwide. As a convenient screening tool that only requires a simple blood draw, our multimodal assay has the potential to help increase adherence to recommended screening guidelines to save lives.”

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening.

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 December 31, 2021 and in its other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, 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.

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