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

Trial Information

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

This study has 2 visits. Visit 1 will be completed day of enrollment, taking about 1 hour.
Visit 2 is a follow up visit within 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 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.

- 35mL 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. Otherwise you will return to the center for visit 2.

The following procedures will be performed:

- You will have a follow-up mammogram test performed. The mammogram visit 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 doctor and/or study staff will assess your health and medical history.

- 35mL 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.