- MammaTyper is used for determining different molecular subtypes of breast cancer to decide on systemic therapy
- It differs from standard immunohistochemistry (IHC) testing by offering a quantitative test which distinguishes more tumour subtypes and is easier to perform
- The briefing includes evidence from randomised controlled trials and diagnostic reproducibility studies which show MammaTyper is more effective than IHC in defining breast cancer subtype to guide chemotherapy
- However, uncertainties include the need for further studies on clinical outcomes after MammaTyper-guided therapy and on the relative utility of MammaTyper compared with other gene-based tests
An in-vitro diagnostic test for determining breast cancer subtypes is the subject of the latest Medtech Innovation Briefing from the National Institute for Health and Care Excellence (NICE).
The briefings aim to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies.
The information provided includes a description of the technology, how it’s used, and its potential role in the treatment pathway.
They also include a review of relevant published evidence and the likely costs of using the technology, but they are not NICE guidance and do not make any recommendations on the value of using the technologies. Whether or not to use the products described is entirely the choice of local staff.
However, they will help to avoid the need for organisations to produce similar information, so saving staff time, effort and resources.
The latest briefing explores the potential impact of using the MammaTyper in-vitro diagnostic test for determining breast cancer subtypes.
Developed by BioNTech Diagnostics; it is used as a diagnostic test on biopsy samples of invasive breast cancer tissue from surgical resection or pre-operative core needle biopsies.
It offers an objective, sensitive, and precise test, based on measuring the upregulation of genes on standard RT-qPCR equipment
The test is based on reverse transcription quantitative real-time polymerase chain reaction (RT-qPCR). MammaTyper then classifies breast cancer into 4 subtypes that have different treatments according to St Gallen (2017) guidelines.
The MammaTyper test uses a standard formalin-fixed paraffin-embedded (FFPE) biopsy sample, which is processed using RNXtract to extract ribonucleic acid (RNA). The sample is then run through a RT-qPCR machine with the MammaTyper test and controls supplied with the test.
The briefing states: “It offers an objective, sensitive, and precise test, based on measuring the upregulation of genes on standard RT-qPCR equipment.
“It would be an alternative to IHC, which is a subjective test that has no defined cut-off and may have inter-observer and inter-laboratory variability for some measures, such as those relating to MKI67. It would also provide additional information on luminal B-like tumour subtypes that cannot be assessed using IHC.”
It adds: “MammaTyper would be used to guide treatment decisions in people with breast cancer.
“The test would be done in secondary care on a surgical resection of the breast cancer tissue (or the initial diagnostic core biopsy) so results are available to guide post-surgical chemotherapy or initial treatment.
“ It would be used in the same place in the care pathway as IHC, to identify people likely to have a low-risk subgroup of ER-positive luminal A-like or B-like disease and to avoid using chemotherapy in these groups.”
It has the potential to make resource savings in avoiding unnecessary chemotherapy, optimising treatment regimens and potentially avoiding the need for more-expensive multigene testing
The current price per patient of MammaTyper is £400. On pricing, the briefing states: “The MammaTyper test would add costs compared with the standard IHC test in initial testing and treatment of breast cancer.
“It has the potential to make resource savings in avoiding unnecessary chemotherapy, optimising treatment regimens and potentially avoiding the need for more-expensive multigene testing.
“As MammaTyper is an objective test, it does not need expert histopathology clinicians to read the result, and so can release staff time.”
But, while trials have found MammaTyper to be more effective than IHC in defining breast cancer subtype to guide chemotherapy, further evidence is still needed, according to the document.
Click here for the full briefing.