Breast Cancer Biomarker Sample Collection for the dtectDx v2.0 Assay Proof of Concept Protocol (Protocol #: dtectDx Breast v2.0)

Trial ID:
IRB-14-6358
Carrie Costantini
The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and...

Inclusion Criteria:

  • Adult women from 25 years of age to below 75 years of age
  • Breast evaluation results of ACR BI-RADSĀ® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
  • Study visit and blood collection within 4 weeks (28 days) of ACR BI-RADS assessment
  • Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
  • Samples collected under IRB approval and Informed Consent
  • Testing performed under IRB approval or waiver (as applicable)
  • Previous approved procedures to enroll patients: breast augmentation & cyst aspiration

Exclusion Criteria:

  • Adults from 76 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 during the 6 months 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.

Contact Info:

  • Sherri Borman
  • bormans@provistadx.com
  • 480-344-9210