Breast Cancer Diagnostics

Current diagnosis protocols for breast cancer screening are not meeting the needs of many patients, including those women with: dense breast tissue, BRCA1 or BRCA2 mutations or a family history of breast cancer. Mammograms have not been an effective screening procedure for these women.

This has resulted in ACS guidelines being written that recommend the use of MRIs for women with a high risk of breast cancer including those with a known BRCA mutation or an immediate family member with a known BRCA mutation. Additionally, they recommend that women with dense breast tissue or a personal history of breast cancer, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or abnormal breast cell changes such as atypical ductal hyperplasia or atypical lobular hyperplasia should talk to their physicians about whether they should have MRIs in addition to mammography.
The use of mammograms in detecting breast cancer has been shown to produce many false positives resulting in additional costly procedures being done.

  •  ~10% of women are recalled from screening mammography for further testing
  •  ~95% of these recalls are false positives
  •  ~50% of women screened annually over a 10-year period experience false positives
  •  7 to 17% of these women will have biopsies

The use of digital imaging for screening of specific patient profiles is not meeting the needs of practitioners, patients or payers. Rather digital imaging, when used for these women, is producing:

  •  Inconclusive diagnoses
  •  Anxiety for patients
  •  Diagnosis uncertainty for physicians.

OncoCyte’s pipeline breast product is being developed to reduce the number of patients with indeterminate mammograms being sent for biopsies. Each year approximately 350k women have suspicious mammograms (BIRADS 3 and 4) requiring additional procedures to confirm the diagnosis. The company’s test is intended to be used in lieu of biopsy for these women and will be designed to deliver a benign result with a high degree of accuracy.

Sources: Rosenberg RD et al. Radiology 2006
Elmore JG et al. New England Journal of Medicine1998
Hubbard RA et al. Annuals of InternalMeducine 2011
Rosenberg RD et al. Radiology 1998
Kerlikowske K et al. Journal of American Medical Association 1996
Porter PL et al. J Natl Cancer Institute 1999