MammaTyper in vitro diagnostic test for determining breast cancer subtypes

The technology described in this briefing is MammaTyper. It is used for determining different molecular subtypes of breast cancer to decide on systemic therapy.

The innovative aspects are that MammaTyper differs from standard immunohistochemistry (IHC) testing: it offers a quantitative test, which distinguishes more tumour subtypes and is easier to do.

The intended place in therapy would be to replace IHC testing in people with early-stage breast cancer.

The main points from the evidence summarised in this briefing are from randomised controlled trials (RCTs) and diagnostic reproducibility studies (UK, US and Europe) including a total of 1,460 adults (1,138 evaluable tumour samples) with early-stage breast cancer in secondary care. It shows that MammaTyper is more effective than IHC in defining breast cancer subtype to guide chemotherapy.

Key uncertainties around the evidence 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.

The cost of MammaTyper is £300 to £400 per unit (exclusive of VAT). The resource impact would be potentially cost saving if using the test leads to avoiding unnecessary chemotherapy, optimising treatment regimens and potentially reducing the need for expensive further multigene testing.