Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification

Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept

The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins in your blood samples. The biomarker results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.

As part of the study, 35 mL or 2 1/2 tablespoons of blood will be drawn from your arm at each study visit.

This study has 2 visits. Visit 1 will take about 1 hour. Visit 2 is a follow up visit at 6 months taking about 1 hour.

Visit 1- Screening and Blood Collection:

The following procedures will be done at the clinical research facility:

• The study doctor and/or study staff will explain the study and all the study procedures.
• You will be asked to review, sign and date this informed consent before any procedures are done.
• The study doctor and/or study staff will ask you questions about your health status and medical history and record this information.
• 35 mL or 2 ½ tablespoons of blood will be collected from your arm.
• The samples will not be labeled with your name but a unique identification code, which means they will be given a number which can be linked to you.

Visit 2 - Follow up:

If you have been diagnosed with cancer between visit 1 and visit 2, you will not be required to complete visit 2. If you have been diagnosed with LCIS or DCIS, you will be requested to return for visit 2. Otherwise you will return to the center for visit 2.

The following procedures will be performed:

• You will have a follow-up breast evaluation performed. Your follow-up breast evaluation may occur prior to Visit 2 if you have it performed at a different facility or it may be performed during this study visit.
• The study doctor and/or study staff will assess your health and medical history.
• 35 mL or 2 1/2 tablespoons of blood will be collected from your arm.
• The samples will not be labeled with your name but a unique identification code, which means they will be given a number which can be linked to you.

Your blood sample will be sent to the study Sponsor, Provista Diagnostics, Inc. for testing.

The test results will not be reported back to the study doctor and will not be used to determine or change your treatment. This testing will be done in addition to any routine testing that your study doctor performs. You will not receive the results of these tests.

Up to 350 subjects will take part in this study. Patients will be enrolled at one of seven sites.

Inclusion Criteria:

• Adult women from 25 years of age to below 50 years of age
• Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
• Study visit and blood collection within 3 weeks (21 days) of ACR BI-RADS assessment
• Patient agrees to return for diagnostic follow-up and blood collection at 6 months unless a positive cancer diagnosis is made between study visits 1 and 2. Individuals diagnosed with LCIS and DCIS will agree to return for visit 2
• Samples collected under IRB approval and Informed Consent
• Testing performed under IRB approval or waiver (as applicable)

Exclusion Criteria:

• Adults from 50 years of age or older and below 25 years of age
• Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
• Subjects that have had a breast biopsy performed at any time prior to the study visit
• Samples not collected under IRB approval and Informed Consent
• Testing not performed under IRB approval or waiver (as applicable)
• Prior breast cancer diagnosis.