Automated Method for Breast Cancer Detection

Automated Method for Breast Cancer Detection

Participants with suspicious breast lesions by mammography will undergo fine needle aspiration (FNA) under ultrasound guidance. The FNA will be read by the cytopathologist and analyzed in the breast cancer detection cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis). We will also receive FNA collected from 60 patients with palpable lesions in South Africa and analyze them samples in our lab with the same method.

Inclusion Criteria:

• Patient must be female
• Patient must be 18 years of age or older
• Patient has been recommended for ultrasound core needle biopsy of a suspicious breast lesion

Exclusion Criteria:

• Patients may be excluded for any condition that in the opinion of the investigator may not make it safe to take part (e.g. certain medicines).