Business
Guardant Health Enrolls First Patient in SHIELD LUNG Study to Evaluate Accuracy of Its Blood Test to Detect Lung Cancer in High-Risk Adults
Prospective registrational study expected to enroll nearly 10,000 patients in 36 months REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc.
About this update from Guardant Health, Inc.
[{"type":"text","content":"\nProspective registrational study expected to enroll nearly 10,000 patients in 36 months\n\n REDWOOD CITY, Calif.--(BUSINESS WIRE)--\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today the enrollment of the first patient in the SHIELD (Screening for HIgh-frEquency maLignant Disease) LUNG study, a nearly 10,000-patient prospective, registrational study to evaluate the performance of its next-generation Guardant SHIELD blood test in detecting lung cancer in high-risk individuals ages 50-80. The study is anticipated to run in approximately 100 centers in the United States and Europe.\n\nLung cancer is the leading cause of death among both men and women in the U.S. It is also the leading cause of cancer death among men, and the second leading cause of cancer death among women worldwide.1 The U.S. Preventive Services Task Force recommends yearly lung cancer screening using a low-dose computed tomography (CT) scan for people ages 50 to 80 years old who are at high risk for lung cancer because of their smoking history, but who don’t have signs or symptoms.2 Despite these recommendations, only 14% of people eligible for a low-dose CT scan are up to date with screening recommendations.3\n\n“Symptoms of lung cancer don’t appear until the disease is already at an advanced stage. That’s why it’s so important to find lung cancer early, before symptoms start,” said Craig Eagle, MD, Guardant Health chief medical officer. “Unfortunately, many people do not follow recommended screening guidelines for lung cancer. We believe a simple blood test could help improve screening rates and detect lung cancer early, when it can most easily be treated.”\n\nEligible participants for the SHIELD LUNG study will include people between the ages of 50 and 80 who are current or former smokers and undergo standard lung cancer screenings using low-dose CT scanning. Enrollment is expected to be complete within 36 months, and if the study is successful, the data will support a pre-market approval (PMA) submission to the U.S. Food and Drug Administration (FDA). Additional information about the SHIELD LUNG study is available on clinicaltrials.gov (NCT05117840).\n\n“The SHIELD LUNG study is the second large-scale screening study initiated by Guardant Health in just over two years to evaluate the performance of our blood tests for...