Circulating Tumor DNA Exposure in Peripheral Blood

This prospective, multi-center, feasibility study represents a feasibility study to determine
the potential of circulating tumor DNA exposure in peripheral blood using a novel process in
a sample of patients with different types of malignant organ tumors and a control cohort
without malignant disease. The study applies a new process to detect ctDNA and other
molecular markers in peripheral blood using: a collection of de-identified blood specimen and
clinical data from up to 10,000 participants from clinical sites across the United States and
Europe. Data collected will include the following: Demographics, Tumor Characteristics,
Information about Treatment, Specimen Assessment, Postoperative Assessment Clinical
information, and Follow-up at intermittent future time points, for up to 15 years. The study
test(s) to be used in this protocol is a multiplexed primer and probe design developed, that
allows detecting a wider set of mutations at a higher sensitivity then conventional
sequencing-based method. This novel process is currently being investigated at Quantgene Inc.

Inclusion Criteria:

- This study will include subjects that are diagnosed with a malignancy (cohort

1) and a negative cohort with subjects that have not been diagnosed with a malignancy
(cohort 2).

- Subjects of both cohorts must:

- Be of age ≥ 18

- Provide written consent for study participation

- Subject of cohort 1 must:

- Have a diagnosis of a malignancy in clinical stage 0 to IV including but not
limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular
carcinoma, non-small cell lung cancer, bladder cancer, melanoma

Subjects of cohort 2 must:

• Meet the listed matching criteria

Exclusion Criteria:

- Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy

- Subjects of cohort 2 must not:

- Have been diagnosed/treated for a malignancy previously