New blood test for colorectal cancer screening approved by the FDA based on results of clinical study conducted at Frontier Clinical Research and other study sites across US

First blood test to be approved by FDA for primary CRC screening meets performance requirements for Medicare coverage and offers a more convenient option for millions of eligible individuals.

Frontier Clinical Research today announced that the U.S. Food and Drug Administration (FDA) has approved the use of a new blood test for colorectal cancer screening based on the results of a clinical study conducted in part at its site. The FDA’s approval of the Shield™ test from Guardant Health for colorectal cancer screening of average-risk individuals age 45 and older was based on the ECLIPSE study, which was conducted at Frontier Clinical Research in collaboration with more than 200 study sites across 37 states.

Frontier Clinical Research is committed to conducting research that leads to meaningful improvements in healthcare and patient outcomes, and we are honored to have contributed to this significant advance in cancer screening. Colorectal cancer is highly treatable if detected early, yet 1 out of 3 eligible Americans are not up to date with their screening in part because of the inconvenience or unpleasantness of other methods. We are proud to have played a role in making this convenient new blood-based screening test more broadly accessible to individuals.

The ECLIPSE study, which enrolled over 20,000 people, evaluated the performance of the test for detecting CRC in average-risk adults. Results published in the March 14, 2024 issue of The New England Journal of Medicine showed that the Shield test demonstrated 83% sensitivity in detecting individuals with CRC and 90% specificity for advanced neoplasia. This performance is in range with other guideline-recommended non-invasive CRC screening methods, in which overall sensitivity ranges from 68% to 92%.

Colorectal cancer is a major public health problem in the United States, where it is the second leading cause of cancer-related deaths. The CRC screening rate in the U.S. is only about 59%,1 which is well below the National Colorectal Cancer Roundtable’s goal of 80% of all eligible individuals.2 This significant gap in CRC screening rates highlights the urgent need for an additional screening option that is easy and convenient for people to complete. A blood test option has the potential to help overcome barriers associated with other CRC screening methods and dramatically improve overall screening rates.

About Frontier Clinical Research

Frontier Clinical Research is a Site Management Organization (SMO) that is focused on providing professional, high quality study conduct and drug/device development services. We bridge the gap between Pharmaceutical companies and patients by recruiting patients into clinical trials. This allows for more affordable and new cutting-edge medications to be approved that may be beneficial to them as well as future generations. We offer a wide range of therapeutic diversity to meet the needs of our patients and the Clinical Research/Pharmaceutical industry.

About Shield

Shield is a 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.

For complete product information about the Shield blood test for CRC screening, including full safety information, visit ShieldCancerScreen.com.