On March 10, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it has submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval (PMA) application for Shield, Guardant Health’s blood test to screen for colorectal cancer (CRC) (Press release, Guardant Health, MAR 10, 2023, View Source [SID1234628515]).
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The submission is comprised of data from the company’s positive ECLIPSE study, an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults. Preliminary results from the study showed that the Shield test achieved 83% sensitivity for the detection of colorectal cancer with specificity of 90%.
"Completing our FDA PMA application for Shield is a significant step forward toward our mission of saving millions of life-years through accessible blood-based cancer screening. We are looking forward to partnering with the agency on bringing this life-saving test to the market," said AmirAli Talasaz, co-CEO of Guardant Health. "Colorectal cancer is the second leading cause of cancer related death, yet one in three eligible adults are not up to date with screening.1 Patient access to blood-based screening can help overcome barriers to traditional screening modalities, especially in underserved populations."
The success of a CRC screening program depends on having tests with acceptable performance, but also on the willingness of the target population to complete the screening test.2 Since the launch of the lab developed version of the Shield test in May 2022, it has shown approximately 90% adherence in a real-world clinical setting, demonstrating the value of blood-based screening to increase adherence to recommended screening protocols.3 In fact, the effective sensitivity of the test, which measures the true impact of a screening test by evaluating adherence and test performance, shows that Shield has the potential to detect more CRCs than traditional modalities.3,4,5,6
About the ECLIPSE study
ECLIPSE is a prospective registrational study to evaluate the performance of Guardant Health’s blood test in detecting signs of CRC compared to a screening colonoscopy in average-risk adults between the ages of 45 and 84 from across the U.S. The ECLIPSE study included more than 200 clinical trial sites in rural and urban communities across 34 states. Study data includes 13% Black, 15% Hispanic and 7% Asian American populations. Enrollment among Black Americans was above average for a clinical trial, which is important given the disproportionate impact of CRC on the black community.7
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 identifies 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.