This trial will be used to test the ability of the Harbinger Health test to detect cancer using blood-based biomarkers in a large cohort of patients with cancer and matched non-cancer controls. The non-cancer controls will be followed for up to 1 year

Harbinger Health Test

Sarah Cannon Development Innovations, LLC

Dax Kurbegov, MD

May Orfali, MD

This is a prospective, multi-center, observational study with a collection of biospecimens and clinical data from approximately 10,000 participants from up to 125 clinical network sites and locations in the United States. The objective of this study is to collect blood samples, tissue samples, and associated clinical data from participants with a variety of solid tumor and hematologic cancers and non-cancer participants for testing and the development of a screening test for early cancer detection.

Development and Validation of Harbinger Health Test for Early Cancer Detection

Cancer ORigin Epigenetics-Harbinger Health - Collection of Blood and Tissue Samples From Cancer and Non-Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test

Analyze Subject's cfDNA from blood samples for "cancer" or "non-cancer" signals using the Harbinger Health test, and compare results of the test to clinical diagnosis

Sub-analysis by clinical diagnosis of cancer type (e.g. Breast cancer) to determine how well the Harbinger Health test detects specific tumor types

Analyze Subject's cfDNA from blood samples to accurately identify specific tumor types (e.g. Breast cancer) using the Harbinger Health test, by comparing results of the test to clinical diagnosis

Assess Harbinger Health test performance with repeat of primary subgroup analysis through Tumor Stage within Cancer Type.

Assess Harbinger Health test performance by repeat of Primary with Subgroup Analysis of Non-Cancer vs. Hyperplasia (Advanced Adenoma).

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