cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease

This is an observational case-control study that includes individuals with cancer and

individuals without known cancer. All participants will have clinical follow-up after

enrollment. A subset of individuals with cancer will also have longitudinal blood

sampling to evaluate the ability of the genome-wide methylome enrichment platform to

detect minimal residual disease. This includes individuals with Stage I-III lung cancer

(Tier 1 Cancers).

At baseline, all participants will provide a blood sample and applicable clinical data.

Participants with a Tier 1 cancer will have clinical follow-up and blood draws after the

completion of first-line treatment, every 3 months for the first year after first-line

treatment, and every 6 months for an additional 2 years. All other cases may have

clinical follow-up once a year for 3 years after enrollment.

Control participants will have clinical follow-up every 6 months for up to 3 years from

enrollment to evaluate cancer status.

The blood test to be used in this study is a highly sensitive, epigenomic-based

genome-wide methylome enrichment platform. The assay includes bisulfite-free,

non-degradative genome-wide DNA methylation profiling from small quantities of cell-free

DNA (cfDNA). Libraries constructed from cfDNA are enriched for methylated CpGs and

preserve the native fragment length. This is followed by high throughput sequencing.

For all assays, samples from participants with cancer and participants without cancer

will be run together to reduce batch effects using methodology determined by the Sponsor.

Results from the liquid biopsy test will not be returned to clinicians or participants.