AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test

Early detection of cancer combined with effective treatment improves survival and quality of
life. Freenome is using a type of artificial intelligence, called machine learning, to
identify patterns of cell-free biomarkers in the blood to detect cancer early. The purpose of
this study is to develop and validate a blood-based assay for the early detection of
colorectal cancer. The study will collect blood and stool samples from healthy patients
undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal
cancer or advanced adenomas. A blood-based test for colorectal cancer and pre-cancerous
lesions could offer an accurate, convenient, and patient-friendly screening option for
current and future generations, and, in doing so, could save and improve lives by increasing
adherence and early detection.

Freenome is looking for three types of patients in this study:

Cohort A:

People ages 50-84 who have been recently diagnosed with (or strong clinical suspicion for)
colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer
treatment has been initiated.

Cohort B:

People ages 50-84 undergoing routine screening colonoscopies for colorectal cancer as part of
their regular medical check-ups. Blood samples must be collected before bowel preparation for
the colonoscopy.

Cohort C:

People 18 years or older who have been recently diagnosed with (or strong clinical suspicion
for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer
treatment has been initiated.

COHORT A

Inclusion Criteria:

- 50-84 years of age (inclusive) at the time of screening

- Recently diagnosed with (or strong clinical suspicion for) primary colorectal cancer
or advanced adenoma with plans to surgically or endoscopically remove the target
lesion(s)

- At least 7 days before but no more than 6 months after the most recent colonoscopy

- Able and willing to provide blood and stool (optional) samples per protocol

- Able to comprehend and willing to sign and date the written informed consent
document(s) and any applicable medical record release documents for the study

Key Exclusion Criteria:

- Personal history of colorectal cancer, colorectal adenomas (excluding non-adenomatous
(e.g., hyperplastic polyps)) or aerodigestive tract cancer (other than most recent
diagnosis)

- Colonoscopy within the previous 9 years (other than most recent diagnosis)

- Overt rectal bleeding within the previous 30 days

- Have a medical condition which, in the opinion of the investigator, should preclude
enrollment into the study.

- Have participated or be currently participating in a clinical research study in which
an experimental medication has been administered during the 60 days up to and
including the date of providing informed consent or may be administered through the
time of the colonoscopy.

- If female, known to be pregnant.

COHORT B

Inclusion Criteria:

- 50-84 years of age (inclusive) at the time of screening

- Planning to undergo a screening colonoscopy within 75 days after providing signed
informed consent

- Able and willing to provide blood and stool (optional) samples per protocol

- Able to comprehend and willing to sign and date the written informed consent
document(s) and any applicable medical record release documents for the study

Key Exclusion Criteria:

- Personal history of colorectal cancer, colorectal adenoma (excluding non-adenomatous
(e.g., hyperplastic polyps)) or aerodigestive tract cancer

- Colonoscopy within the previous 9 years

- Overt rectal bleeding within the previous 30 days

- Have a medical condition which, in the opinion of the investigator, should preclude
enrollment into the study.

- Have participated or be currently participating in a clinical research study in which
an experimental medication has been administered during the 60 days up to and
including the date of providing informed consent or may be administered through the
time of the colonoscopy.

- If female, known to be pregnant.

COHORT C

Inclusion Criteria:

- At least 18 years of age (inclusive) at the time of screening

- Recently diagnosed with (or strong clinical suspicion for) primary colorectal cancer
or advanced adenoma with plans to surgically or endoscopically remove the target
lesion(s)

- At least 7 days before but no more than 6 months after the most recent colonoscopy

- Able and willing to provide blood and stool (optional) samples per protocol

- Able to comprehend and willing to sign and date the written informed consent
document(s) and any applicable medical record release documents for the study

Exclusion Criteria:

- Have a medical condition which, in the opinion of the investigator, should preclude
enrollment into the study.

- Have participated or be currently participating in a clinical research study in which
an experimental medication has been administered during the 60 days up to and
including the date of providing informed consent or may be administered through the
time of the colonoscopy.

- If female, be known to be pregnant.