Early Detection of Breast Cancer

Inclusion Criteria:

A). For Cohort A (500 subjects are targeted to enroll)

No prior diagnosis of (any) cancer
Women aged 40 years and above at the time of mammography
Provision of signed informed consent
Capable of providing adequate health history
No co-morbidity which could impair study participation or sample collection
Blood draw within sixty (60) days of performance of screening mammography
A redacted/deidentified mammography report will be available and provided
If any prior mammography was performed, the BI-RADS score should be 1 or 2 or 3
Willingness to accept follow-up contact every 6 months for up to 2 years.
Agreeable to share any future biopsy or imaging data for a maximum of 2 years from study blood draw.

B). For Cohort B (BI-RADS 4 and 5) (200 subjects are targeted to enroll)

No prior diagnosis of (any) cancer
Women aged 40 years and above at the time of mammography
Provision of signed informed consent
Current mammography indicating BI-RADS 4a,4b, 4c, or 5
Capable of providing adequate health history
No co-morbidity which could impair study participation or sample collection
Blood draw within sixty (60) days of mammography and prior to biopsy of the breast
Yet to undergo tissue diagnostic procedure for breast lesion such as fine needle, core, or excisional biopsy
A redacted/deidentified mammography report and redacted/de-identified pathology report will be available and provided
Willingness to accept follow-up contact every 6 months for up to 2 years.
Agreeable to share any future repeat biopsy or imaging data for a maximum of 2 years from study blood draw.

C). Exclusion Criteria

Prior diagnosis of (any) cancer
Subjects who are receiving any investigational agent.
Pregnant women are excluded from this study
Breastfeeding women are excluded from this study
Blood transfusion within 30 days prior to screening,
Subject has any condition that in the opinion of the investigator should preclude participation in the study.