Digistain Breast
Results before the next appointment.
Digistain Breast gives a prognostic recurrence-risk score for HR-positive, HER2-negative early breast cancer, measured from the tumour’s own chemistry and delivered in time for the treatment conversation.
Left: a stained tissue section. Right: a Digistain mid-infrared chemical image.
Intended use
What Digistain Breast is
Digistain Breast is in vitro diagnostic software that gives a quantitative prognostic score for risk of recurrence and recurrence-free survival at 5 and 10 years. It is used as a categorical (High/Low) prognostic indicator alongside other clinicopathological factors in pre- and post-menopausal women with HR-positive (ER+ and/or PR+), HER2-negative, stage I–II invasive breast cancer with 0–3 positive lymph nodes, treated with adjuvant endocrine therapy alone.
It is not intended for diagnosis, for predicting response to therapy or for selecting therapy, and it is not a companion diagnostic.
For use by trained laboratory personnel in a clinical laboratory, on surgical resection FFPE sections. Core biopsies are not suitable.
Availability
How it reaches the patient
Hospitals and laboratories can run the test and issue results themselves, or use Digistain’s laboratory service.
Markets where Digistain Breast is available: [LIST TO CONFIRM]
Information for you
Clinicians
Validation design, published performance with study, population and endpoint, limitations and turnaround.
Laboratories
Workflow, specimen requirements, released configuration, training and support.
Patients
Plain-language information about the test and how to ask your doctor.
Regulatory status and intended use
Intended use. Digistain Breast is in vitro diagnostic software that gives a quantitative prognostic score for risk of recurrence and recurrence-free survival at 5 and 10 years. It is used as a categorical (High/Low) prognostic indicator alongside other clinicopathological factors in pre- and post-menopausal women with HR-positive (ER+ and/or PR+), HER2-negative, stage I–II invasive breast cancer with 0–3 positive lymph nodes, treated with adjuvant endocrine therapy alone. It is not intended for diagnosis, for predicting response to therapy or for selecting therapy, and it is not a companion diagnostic. For use by trained laboratory personnel in a clinical laboratory, on surgical resection FFPE sections. Core biopsies are not suitable.
United Kingdom: UKCA-marked (self-declared), CE-marked under the IVDD, and registered with the MHRA.
European Union: CE-marked under the IVDD. IVDR Class C conformity assessment in progress with notified body QMD Services (2962).
United States: Not currently available in the US.
Other markets: [STATUS PER MARKET]
ISO 13485:2016 certified (LRQA) for the design and development of IVD software used in cancer management.