Development and Validation of Harbinger Health Test for Early Cancer Detection

Inclusion Criteria:

Inclusion Criteria - Both arms

Subjects must meet the following criteria in order to be included in the research study:

Written or electronic informed consent
Subject is 20 - 79 years of age at the time of signature of the informed consent form (ICF)
Male or female subjects

Inclusion Criteria Arm 1 - Cancer Subjects

Arm 1 subjects enrolled in the study must meet the following inclusion criteria:

A confirmed diagnosis or high suspicion of cancer (stage I to IV solid cancer or hematologic cancer)
Subject's cancer is treatment-naïve

Inclusion Criteria Arm 2 - Non-Cancer Subjects (All Cohorts)

Arm 2 subjects enrolled in the study must meet the following inclusion criteria:

Subject's health permits participation and the subject is not suspected of having cancer based on provider assessment.
The subject was not diagnosed with cancer or received cancer treatment within the last 5 years (persons with completely resected ductal carcinoma in-situ or non-melanoma skin cancer are permitted).

Exclusion Criteria:

Exclusion Criteria - Both arms

Subjects who meet any of the following criteria will be excluded from study entry:

Subject is suffering from any febrile illness defined as a temperature >101.5°F within the last 48 hrs.
Subject is pregnant (by self-report of pregnancy status).

Exclusion Criteria Arm 1 - Cancer Subjects

Subjects who meet any of the following criteria will be excluded from study entry:

Subject has a known prior diagnosis of any other type of cancer (except completely resected ductal carcinoma in-situ or non-melanoma skin cancer) separate from the confirmed cancer diagnosis associated with study enrollment.

Subject is currently receiving, or has in the past received, any of the following definitive therapies to treat their current cancer:

Surgical treatment, surgical removal, or surgical management of the cancer beyond that required to establish the cancer diagnosis. Surgical or biopsy procedures that remove more tissue than required to establish the cancer diagnosis, or that were performed to manage symptoms or initiate cancer treatment prior to blood sample collection will be considered 'definitive' and are not permissible regardless of the residual tumor mass remaining in the subject.
Chemotherapy (local, regional, or systemic) including chemoembolization targeted therapy;
Immunotherapy including cancer vaccines;
Hormone therapy; or
Radiation therapy (a single dose of palliative radiation prior to study start is allowed).
The subject is a recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.

Exclusion Criteria Arm 2 - Non-cancer Subjects

Subjects who meet any of the following criteria will be excluded from study entry:

- The subject is the recipient of an organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.