Essential Portfolio

prognostic profiling

Conventional histopathological evaluation, including size, grade, stage, and mitotic frequency, is already supplied by Medical Solutions through a specialist team of pathologists led by Professor Ian Ellis, and provides a basic assessment of a breast cancer patient’s tumour characteristics. These methods are comprehensive and comply with WHO, EU, RCPath minimum dataset and CAP guidance. Furthermore this form of evaluation underlies “prognostic profiling”, which predicts survival. Specific algorithms are used to generate scores that are in turn related back to historic US and UK clinical datasets for breast cancer. At Medical Solutions™ we utilise the Nottingham Prognostic index (NPI), which is a well-established tool in the UK. NPI predicts survival based upon tumour grade, size and stage, however it is of lesser value in making treatment decisions. A more recent development is Adjuvant Online, an online service which generates survival probability figures based upon similar input data to the NPI but also calculates the benefit to be expected from adjuvant treatment (hormonal or chemotherapy). This program has recently been developed further to factor in genomic information, such as the recurrence score generated by the Oncotype DX™ assay, before arriving at a result.

These types of prognostic scores, based on clinicopathological features, will be the central component of your report, providing both physician and surgeon with a relatively accessible and comprehensible evaluation of disease outcome.

oestrogen receptor (ER) and progesterone receptor (PR)

The value of morphological assessment can be enhanced by the use of a range of tissue based assays performed in our Reference Laboratory. These provide further information to aid in assessing prognosis, and perhaps more importantly in assessing adjuvant treatment suitability. Two such tests, recommended by NICE guidance, and in which we are already providing to the NHS and private healthcare sectors, are ER/PR and HER2 tests.

Oestrogen and progesterone receptor status is determined immunohistochemically. While providing some prognostic information, these paired tests are also used routinely in a treatment decision role, to determine suitability for hormone therapies such as Tamoxifen or aromatase inhibitors. Medical Solutions™ already utilise our own in-house standardised and validated tests, as well as commercially available assays for both Oestrogen and Progesterone receptor. Thus providing a comprehensive and analytically robust service to the clinician.

HER2 protein and gene analysis

Over–expression of the membrane associated receptor protein HER2 (erbB2) as a consequence of gene amplification occurs in 10-20% of breast cancers, and importantly is associated with a poorer prognosis. Immunohistochemical demonstration of HER2 protein over-expression in a breast tumour (or confirmation of gene amplification by in situ hybridisation in borderline cases) is a prerequisite for use of HER2-targeted therapies such as Trastuzumab (Herceptin^TM). Medical Solutions offers the FDA-approved, standardised and validated DAKO Herceptest assay for assessment of HER2 protein expression, and the Abbott/Vysis Pathvysion assay for assessment of HER2 gene amplification status. Both methods of evaluation follow UK guidelines.

ordering

For information on how to order our new Portfolios please contact our Business Development Manager.