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 consentform (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 orhematologic cancer) by imaging within 180 days prior to enrollment; not to includemyelodysplastic and myeloproliferative syndromes

• Subject's cancer diagnosis is based upon assessment of a pathological specimen orhigh suspicion of cancer by imaging

• 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 havingcancer based on provider assessment.

• The subject was not diagnosed with cancer or received cancer treatment within thelast 5 years (persons with completely resected ductal carcinoma in-situ ornon-melanoma skin cancer are permitted).

Part 1B Only :

• Subject has no known current cancer and has 1 of the follow conditions:

o An Advanced Adenoma (AA) of the gastrointestinal tract as defined as an adenoma that is ≤10mm in size Subjects with any one of the criteria would be eligible High grade displasia or ≥10 adenoma: any size Tubulovillous adenoma, any size Tubular adenoma ≥10mm Traditional serrated adenoma ≥10mm

Exclusion Criteria:

Subject self-reporting OR available medical records at the time of screening are acceptable for assessment of all 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°Fwithin 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 with a prior history of cancer within 5 years will not be allowed toparticipate in the study

• More than 1 active cancer diagnosis (ie. a subject presenting with recurrent breastcancer and newly diagnosed lung cancer would be excluded; subject with prior (>5years ago) treated breast cancer without recurrence and presenting with newlydiagnosed lung cancer would be eligible).

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

• Surgical treatment, surgical removal, or surgical management of the cancerbeyond that required to establish the cancer diagnosis. Surgical or biopsyprocedures that remove more tissue than required to establish the cancerdiagnosis, or that were performed to manage symptoms or initiate cancertreatment prior to blood sample collection will be considered 'definitive' andare not permissible regardless of the residual tumor mass remaining in thesubject.

• Chemotherapy (local, regional, or systemic) including chemoembolizationtargeted therapy;

• Immunotherapy including cancer vaccines;

• Hormone therapy; or

• Radiation therapy (a single dose of palliative radiation prior to study startis allowed).

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

• Subject who has undergone a bowel preparation for a gastrointestinal malignancywithin 3 days of an anticipated blood draw.

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.