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Guardant Health Announces Shield™ Blood Test Available in US to Detect Early Signs of Colorectal Cancer in Average-Risk Adults
Highly sensitive Shield test offers convenient screening method that can be completed with simple blood draw, helping overcome barriers to compliance Test
About this update from Guardant Health, Inc.
[{"type":"text","content":"\n\nHighly sensitive Shield test offers convenient screening method that can be completed with simple blood draw, helping overcome barriers to compliance\n\n\nTest demonstrated sensitivity of 91% in colorectal cancer and 20% in advanced adenoma detection with specificity of 92% in validation studies\n\n\n PALO ALTO, Calif.--(BUSINESS WIRE)--\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the availability of Shield™, the company’s first blood-based test for the detection of early-stage colorectal cancer (CRC). The test, which only requires patients to complete a simple blood draw, is intended for adults age 45 and older who are not up to date with recommended screening guidelines, show no symptoms, and are at average risk for CRC.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220502005342/en/Shield Test Kit (Photo: Business Wire)\nColorectal cancer is the second-leading cause of cancer-related deaths in the U.S.1 Today, one in three adults have not completed the recommended CRC screening even though colorectal cancer is curable if caught early. Barriers associated with currently available methods, such as a colonoscopy or a stool-based test, can make the process unpleasant, time-consuming and difficult to complete.2 With a simple blood draw, the Shield test overcomes these barriers because it requires no special preparation, no sedation, no dietary changes, no extra time away from family or work, and it can be completed as part of any patient office visit.3\n\nThe clinical performance of the Shield assay was validated using a set of 309 patient samples, including 92 with CRC, 51 with advanced adenomas and 166 normal cases. CRC patient samples were accrued across six unique cohorts collected in the U.S., Canada and the EU, and samples with advanced adenoma and normal cases were collected in the U.S. Subjects were balanced by age (a mean of 64 years old) and gender. The Shield assay demonstrated 91% sensitivity (detection rate) for CRC (95% confidence interval [CI]: 84% - 95%), including 90% for Stage I, 97% for Stage II, and 86% for Stage III CRC. The assay also demonstrated 20% sensitivity for advanced adenomas (95% CI; 11% - 32%) and 92% specificity (true negative rate) in normal cases.\n\n“The availability of the Shield t...