Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects

The primary purpose of this observational study is to assess the physician's clinical
practice patterns while using VeriStrat testing in subjects with NSCLC whose tumors are
epidermal growth factor receptor (EGFR) wild-type (negative) or have unknown EGFR mutational
status. This study will also attempt to further validate that VeriStrat test results stratify
subjects by clinical outcomes in the real world, uncontrolled clinical setting while
exploring whether certain therapeutic approaches may yield opportunities for further study.

Predictive tests that aid physician therapeutic decision making are critical for optimizing
subject outcomes while minimizing toxicity and associated treatment costs. This study will
provide data for the validation of immunotherapy tests currently being developed.
Immunotherapy mechanisms are dependent upon the interactions between the tumor, tumor
microenvironment, and the patient immune system. As such, a successful predictive test will
reflect the complex interplay between tumor and host. The multivariate tests from Biodesix
have the advantage of being able to assess this complex biology.

The information gained from this research will not only guide the adoption of the VeriStrat
test and inform medical decision making, including treatment choice, but will allow the
validation of additional mass-spectrometry-based proteomic tests.

Inclusion Criteria:

1. Subject must be 18 years of age or older at time of signing informed consent form
(ICF).

2. A diagnosis of NSCLC.

3. EGFR mutation status wildtype or unknown.

4. Subject is willing to provide serum samples for VeriStrat testing.

5. For subjects with UNKNOWN EGFR status only: The subject must be willing to provide
plasma samples for GeneStrat testing.

6. Subject is willing to provide serum samples for research, understanding that no test
results will be made available either to the subject or the treating physician.

7. If subject has had prior treatment for local disease, disease progression was
documented and treatment was completed prior to VeriStrat testing.

8. Subject is able to read and understand the ICF, and agrees to comply with study
procedures and requirements.

Exclusion Criteria:

1. History of prior malignancy within 2 years of signing ICF (except for adequately
treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix,
superficial bladder cancer, or early stage prostate cancer, without evidence of
recurrence).

2. Subject's ability to understand the requirements of the protocol or to provide
informed consent is impaired or subject is unwilling to comply with the protocol
requirements.