Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

This is a prospective, multi-center, observational study to evaluate the performance of

the Freenome Multiomics Blood Test in screening eligible participants for lung cancer.

Enrollment will be open to all eligible participants for screening chest CT scan as part

of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria

for this study and provide informed consent will be enrolled and blood sample collection

must be completed within 30 days of signing the informed consent. Optimally, the

screening chest CT will be completed on the same day of the study blood collection,

however up to 45 days will be allowed after study blood collection to obtain a screening

chest CT.

The study will also collect demographic data and relevant clinical data, such as medical

history, lifestyle, occupational and environmental exposure(s), family history, and

clinical laboratory data. All reports and clinical notes regarding the diagnostic tests

and procedures related to lung cancer diagnosis or lung lesion assessment, such as

histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging

reports will be collected as part of follow up to the screening chest CT scan.

All enrolled subjects will be followed prospectively from the date of the baseline

screening chest CT until a minimum of 24 months, or until a premature study endpoint

inclusive of withdrawal of consent or death.