On January 18, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported 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 (Press release, Guardant Health, JAN 18, 2022, View Source [SID1234605534]). The study is anticipated to run in approximately 100 centers in the United States and Europe.

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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.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

"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."

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).

"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 early cancer detection. Our unique combination of medical, clinical and operational expertise, in partnership with our clinical investigators and study sites, allows us to move forward rapidly with enrollment for this very important study," said AmirAli Talasaz, Guardant Health co-CEO. "Lung cancer screening is known to save lives. This study will add to the growing body of evidence that supports the use of our blood tests to screen for cancer early. It also reinforces our deep commitment to providing patients with a simple blood test that is accurate and easier than the current standard of care, to catch lung cancer at the earliest stages where there can be better patient outcomes.