On February 15, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the initiation of a new study to examine patient preference for Shield, Guardant Health’s blood test to screen for colorectal cancer (CRC), and if having the option of a blood test improves patient adherence to screening (Press release, Guardant Health, FEB 15, 2023, View Source [SID1234627281]). The study will be conducted by the Center for Asian Health Equity – University of Chicago Medicine (CAHE-UCM).
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In this study, Understanding Patient Preference on Colorectal Cancer Screening Options (U-Screen), led by University of Chicago physician-scientist and colorectal cancer specialist Dr. Karen Kim, patients receiving care at Federally Qualified Health Centers (FQHC) who fail to complete guideline-recommended screening will have the option to complete their screening with a Shield blood test. Shield test performance was recently clinically validated by the ECLIPSE Study — one of the largest cancer screening studies of its kind — and achieved 83% sensitivity for the detection of CRC.1
Screening for colorectal cancer has been shown to improve survival rates, yet one in three adults have not completed the recommended CRC screening.2,3 Adherence to CRC screening is particularly low among minority populations: only 59% of individuals aged 50 and older who are Hispanic and 65% of individuals who are Black/African American are up to date with recommended screenings.4 Screening rates are even lower in FQHCs, where only 40 % of eligible patients were screened for CRC in 2020.5
There are significant barriers associated with established CRC screening methods — such as a colonoscopy or a stool-based test — including patient preferences, time and difficulty to complete the procedure.6 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.7 Since the launch of the Shield test, it has shown approximately 90% adherence demonstrating the value of blood-based screening in a real-world clinical setting.8
"Failing to complete recommended screening is a significant factor contributing to the high rate of cancer-related deaths in underserved populations," said AmirAli Talasaz, Guardant Health co-CEO. "We believe patient access to a highly accurate blood test can increase overall compliance to screening, which is critical to improving CRC outcomes, and we are excited to partner with CAHE-UCM on such an important study."
According to Dr. Kim, the Sara and Harold Lincoln Thompson Professor of Medicine, Vice Provost for Research, and founder of the Center for Asian Health Equity – University of Chicago Medicine, "This study will use an implementation science approach to help us better understand patient and provider preferences for colorectal cancer screening so we can increase screening and reduce the unnecessary burden of colorectal cancer among all populations."
About the U-Screen Study (NCT05536713)
The study will enroll people between the ages of 45 and 75 who are at average risk of developing CRC and have failed to complete guideline-recommended screening. Up to 2,400 patients will be enrolled during the three-year study period at three Federally Qualified Health Centers (FQHC), which have multiple clinics in Illinois and Indiana and provide primary care services to racial/ethnic minority and low-income populations.
About the Shield Test
The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA). Specifically, the test uses a multi-modal approach to identify specific characteristics of the DNA that may indicate the presence of cancer.
The clinical performance of the Shield assay was validated using an analyzed set of over ten thousand patient samples in a screening study. The test demonstrated 83% sensitivity in detecting individuals with CRC. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. This test also demonstrated 13% sensitivity in detecting advanced adenomas.
Shield is commercially available for eligible individuals by prescription only through healthcare professionals. This LDT (Laboratory Developed Test) is intended to be complementary to, and not a replacement for, current recommended CRC screening methods. A negative result does not rule out the presence of cancer. Patients with an abnormal blood-based screening result should be referred for a diagnostic colonoscopic evaluation.
More information about the Shield test is available at bloodbasedscreening.com.