Frequently Asked Questions

Digistain® Breast is intended for post-surgery risk stratification in patients with ER-positive, HER2-negative, Stage 1 or 2 invasive breast cancer and no more than 3 involved lymph nodes. The result is considered by the multidisciplinary team alongside established clinico-pathological factors.

Digistain® Breast is used after surgery. Its result is one input considered by the multidisciplinary team alongside established clinico-pathological factors.

Digistain® uses infrared spectrometry to analyse spectroscopic-derived tissue features from tumour biopsies. This generates the Digistain® Index (DI), an infrared spectroscopic measurement of tumour tissue. The DI, combined with standard clinicopathological features, is processed through a proprietary validated multivariate statistical model to produce a risk stratification output: the Digistain® Prognostic Score (DPS), which recurrence-risk information for consideration by the multidisciplinary team in the post-surgical setting.

Yes, Digistain® has been clinically validated in a retrospective cohort study of 801 ER-positive, HER2-negative patients with a median follow-up of 12.7 years. The study reported hazard ratios for recurrence-free survival between low- and high-risk groups; please see the publication for the values.

STEP 1 of 5

Contact Clinician Support (support@digistain.co.uk) to obtain specimen transportation kit boxes, pre-printed shipping materials, and pathology guidelines for sample preparation. Shipping kits arrive within 2 to 3 business days.

STEP 2 of 5

Online ordering of the Digistain test is available via our international portal.

Contact Clinicians Support (support@digistain.co.uk) if you still need to receive your activation email or want to sign up for an online ordering account.

Log in with your credentials to place an order or read reports online.

STEP 3 of 5

Prepare the specimen for submission. Detailed instructions are provided with the specimen box.

STEP 4 of 5

Ship the specimen in the specimen kit box to our centralised laboratory in Newport Pagnell, UK, using the pre-printed UPS Air Waybill and Commercial Invoice. Digistain covers the shipping charges using UPS. Clinicians Support will arrange sample pick up.

STEP 5 of 5

Results are returned via a secure email to the ordering physician within 1-2 days of receipt of the specimen (provided that all information required has been included on the online order).