On May 21, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported data showing its blood-based multimodal test achieved clinically significant thresholds of sensitivity and specificity in detecting colorectal cancer (CRC) (Press release, Guardant Health, MAY 21, 2022, View Source [SID1234614928]). These data were presented during an oral presentation at Digestive Disease Week 2022.
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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."