FirstLook Lung

Casandra

Casandra Test Code DE20145Version 1 (DRAFT)

Performing Lab

Lab DELFI DiagnosticsLab Test ID N/A

Clinical Use

Use

FirstLook Lung is a noninvasive, blood-based lung cancer screening test for adults who meet USPSTF eligibility criteria for low-dose CT screening. The test uses next-generation sequencing and DELFI’s fragmentomics approach to analyze genome-wide cell-free DNA fragment patterns in plasma and help determine the likelihood that lung cancer would be detected by LDCT. It is intended to support—not replace—LDCT screening by helping providers identify patients who may benefit from follow-up imaging.

Special Instructions

FirstLook Lung is intended for adults ages 50–80 with at least a 20 pack-year smoking history who currently smoke or quit within the past 15 years. An Elevated result indicates a higher likelihood that lung cancer may be detected by LDCT, while a Not Elevated result indicates a lower likelihood; appropriate clinical follow-up should be determined by the ordering provider in the context of the patient’s screening eligibility, risk factors, and current lung cancer screening guidelines.

Limitations

FirstLook Lung is a laboratory-developed test and is not a diagnostic test for lung cancer. It does not replace LDCT, biopsy, imaging interpretation, or clinical evaluation, and a Not Elevated result does not rule out lung cancer. Reported performance, including high negative predictive value, applies to USPSTF-eligible screening populations and should not be generalized to patients outside the intended-use population.

Test Details