NEW YORK – Guardant Health on Tuesday said it has enrolled the first patient in the prospective SHIELD LUNG study, which is evaluating its SHIELD blood test's ability to detect lung cancer in high-risk individuals.
The company plans to enroll 10,000 current or former smokers between ages 50 and 80 at 100 sites in the US and Europe. Participants will submit blood samples for lung cancer screening using the SHIELD test. They will also be screened using a standard CT scan.
Guardant expects to complete enrollment in the trial within three years and submit the results as part of a premarket approval application for the test with the US Food and Drug Administration.
"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," AmirAli Talasaz, Guardant Health co-CEO, said in a statement. "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."
Guardant is also exploring the ability of its LUNAR-2 blood test to detect colorectal cancer early in the 12,750-patient ECLIPSE study. The company expects results from that trial this year and aims to submit the data to the FDA seeking approval by the end of 2022, Guardant executives said at the 40th Annual JP Morgan Healthcare Conference last week.