Clinical Study of BioView Target -FISH Lung Cancer Detection Test

Inclusion Criteria:

- Subjects with 0.8-3 cm solitary pulmonary nodules with high probability for
malignancy

- Candidate is scheduled to undergo lung biopsy procedure to determine clinical
diagnosis, such as Bronchoscope biopsy, Electromagnetic Navigation Bronchoscopy,
fiber optic Bronchoscopy, Needle biopsy, CT guided, Percutaneous Transthoracic Needle
biopsy, Transthoracic Needle Biopsy, Open biopsy for Diagnostic Resection or
Video-Assisted Thorascopic Surgery.

- Candidate who is capable of undergoing sputum induction.

- Ability to understand the investigational nature of the study and sign the informed
consent.

Exclusion Criteria:

- Subjects who pose a high clinical risk for diagnostic bronchoscopy or transthoracic
biopsy for definitive diagnosis.

- Subjects already diagnosed with lung cancer, or previously treated for lung cancer.

- Subjects who experienced pneumonia within last 12 weeks.

- Subjects who experienced an acute respiratory infection within the last 2 weeks

- Cases without sufficient documentation of diagnosis or follow-up will not be
included.

- Treatment for, or evidence of any cancer other than nonmelanoma skin cancer or
carcinoma in situ within the last 3 years.

- Subject who lack the capacity to consent.