Guardant Health, Inc. announced 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. Lung 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.1The 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.

Symptoms of lung cancer don't appear until the disease is already at an advanced stage. Eligible 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).