Be DNA Certain your breast biopsy belongs to you.

breast biopsy patient


Did you know the biopsy evaluation process requires up to 18 steps and several medical professionals working at different locations? To help protect patients from a breast cancer misdiagnosis, the patented know error® system ensures that surgical biopsy samples are free from contamination and belong exclusively to the assigned patient.

Published articles in the American Journal of Clinical Pathology* indicated that up to 3.5% of the biopsy specimens being evaluated may not belong exclusively to the patient being diagnosed, and in the case of Biomarker Testing, a specimen admixture (contaminated with another’s DNA) can cause incorrect findings and confound the biomarker results leading to erroneous therapy and adverse patient outcomes.

As part of the routine biopsy process for breast cancer your physician can request the know error® system for breast biopsies. If you are diagnosed with cancer a DNA test will be used to match your reference swab (taken at the time of your biopsy) to your breast biopsy tissue(s). You and your physician will then be able to move forward with a personalized treatment plan knowing you have eliminated any potential specimen contamination errors and that the cancer diagnosis is correctly ascribed to you.

The know error® system uses three simple steps to ensure that when you receive your breast biopsy results they are free from contamination and they belong exclusively to you:


1. Swab  

Your DNA sample is taken by gently swabbing the inside of your cheek at the time of your biopsy.



2. Sample

Your biopsy tissue sample(s) are placed in bar-coded specimen vials and sent to pathology for evaluation.


3. DNA Match

DNA Specimen Provenance Assay (DSPA), a DNA test, compares your (1) reference swab with the (2) cancerous biopsy tissue sample to ensure a (3) DNA match.

You and your physician can prevent a misdiagnosis due to biopsy specimen contamination and/or patient transposition errors with the know error® system for breast biopsies.

*Pfeifer JD, Liu J. Rate of occult specimen provenance complications in routine clinical practice. Am J Clin Path. 2013;139(1):93-100.
*Sehn JK, Spenser DH, Pfeifer JD, et al. Occult specimen contamination in routine clinical next-general sequencing testing. Am J Clin Path. Oct 2015;144:667-674.


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