Guardant Health Inc. announced that the Shield by Guardant blood-based screening test is now widely accessible for physician order through the nationwide connectivity of Quest Diagnostics, equipping clinicians with access to blood-based screening innovation for colorectal cancer (CRC) through one of the largest diagnostic ecosystems in the United States. Shield is the first and only blood test to receive full FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older. Under the agreement, providers that order lab testing from Quest can now directly access Shield through their existing Quest account and electronic health record (EHR).
Quest provides healthcare connectivity solutions to nearly 650,000 clinician and hospital accounts annually in the United States. Providers can also utilize Quest?s approximately 2,000 patient service centers and approximately 6,000 in-office phlebotomists across the United States for blood draws for Shield. As part of the strategic arrangement, Quest?s national commercial sales team will actively educate primary care physicians about access to the test.
Colorectal cancer is the second leading cause of cancer-related deaths in the U.S. with a 91% five-year survival rate if caught in early stages. Yet, over 54 million people do not complete the recommended screening, in part because they find the available options, colonoscopy and stool tests, unpleasant or inconvenient. With Shield, individuals can be screened with just a blood draw, helping to detect cancer early, when it is more treatable.
Shield is proven to increase screening rates in the real world, with 93% of patients completing the test in the first 100,000 Shield tests ordered ? a significant improvement in screening adherence rates over other types of tests. Recently, the National Comprehensive Cancer Network included the Shield blood test in its updated CRC screening guidelines, paving the way for improved patient access and additional major clinical guideline inclusions.
Shield is covered by Medicare, Veterans Affairs Community Care Network and TRICARE, and is commercially available across the U.S. Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit.
A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.
