Frequently Asked Questions
Digistain® Breast measures tissue-level biomarkers derived from infrared spectroscopic analysis. Using infrared spectrometry, it captures a unique spectral signature from each biopsy, generating over 10,000 data points tailored to each woman’s biology. This data is then analysed using a validated multivariate statistical model to estimate the 10-year risk of breast cancer recurrence.
Your treating team will use your result alongside other information about your cancer.
You may be eligible for the Digistain® Breast if you meet the following criteria. Your treating team will confirm whether the test is appropriate for you:
- Your breast cancer is oestrogen receptor-positive (ER+).
- Your breast cancer is human epidermal growth factor receptor-negative (HER2-).
- You have been recently diagnosed with stage I or II invasive breast cancer.
- You have no more than 3 involved lymph nodes.
If you’re unsure whether Digistain® is right for you, consult your doctor for guidance.
Digistain® Breast usually returns reports within 1-2 days of specimen receipt at our UK laboratory (courier transit is additional). International courier delivery typically takes 48 to 72 hours.
Digistain® Breast has been clinically validated, reporting prognostic performance for recurrence-free survival in a study of 801 patients. What sets Digistain® apart is its innovative new approach, using infrared spectroscopy of routine tissue sections without RNA extraction.
Digistain® Breast is reimbursed by selected UK private insurers including Bupa, WPA and Healix (coverage varies by policy). Contact your insurance provider to check your coverage.
Patients are unable to order a test directly. A physician must send the requisition form along with the samples.
Digistain® Breast is available in Great Britain and selected international markets, subject to local regulatory and ordering requirements.
ER+ stands for oestrogen receptor-positive, the cancer cells have receptors that bind the hormone oestrogen. ER+ cancers may grow in response to these hormones, but they can often be treated with hormone therapies that block or reduce hormone levels in the blood.
HER2- stands for human epidermal growth factor receptor 2-negative: the cancer cells do not produce excess HER2 protein. Your oncologist can explain what this means for your treatment, meaning the breast cancer cells do not produce excess amounts of the HER2 protein. HER2 is a protein that promotes cancer cell growth, so HER2- cancers typically grow more slowly and are less aggressive than HER2-positive cancers. Since HER2-targeted therapies are ineffective for HER2- cancers, treatment usually focuses on other options like hormone therapy or chemotherapy, depending on the cancer’s other characteristics.
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