Laboratory reagents

Tender description

Gene panel testing for those tumours where molecular results impact diagnosis, treatment or prognosis, is implemented on an all Wales basis. The all Wales Genetic Laboratory (AWGL) has been delivering Precision Medicine molecular pathology services for cancer patients since 2008, and has been a UK leader in this field. Molecular services have been commissioned and delivered on a test-by-test basis as the associated therapy was approved for a given tumour type (e.g. KRAS, EGFR, BRAF, BRCA). This approach is now neither cost-effective, tissue-effective nor particularly rapid as multiple tests are performed for each tumour sample. It is therefore time to move to gene panel testing, as has been demonstrated in both the CR-UK Stratified Medicine Programme and the Novartis joint working agreement (both for lung cancer). The Novartis project currently funds gene panel testing for lung cancer patients in Cardiff until March 2017. For many tumour types (or sub-types) there are still no associated targeted treatments. However, there is now a clinical need to molecularly characterise tumour samples for an increasing number of cancer types, to directly inform treatment or because new targeted treatments are anticipated imminently. For these sub-groups, there is additional utility in sign-posting patients towards molecularly stratified clinical trials. We have identified that patients with lung, colorectal, metastatic melanoma, head and neck, metastatic breast, ovarian, prostate, thyroid, and a small number of early onset breast cancer patients may benefit from this analysis. We propose to develop and deliver universal gene panel testing on an all Wales basis for specific sub-groups of tumours where there is good clinical utility for current treatment decisions, and imminent treatment decisions. The delivery of gene panel tests for the above group of tumours will provide treating oncology teams with prognostic, predictive and sometimes diagnostic information to support their decision making. Therefore patients will benefit from molecularly directed treatment, where those treatments are available in Wales. The project will tackle the requesting pathway from the multi-disciplinary team (MDT) and pathology (for tissue acquisition). A commercial universal gene panel of 25-30 genes will be established that will meet the molecular needs of all of the tumour types to be analysed, thus streamlining laboratory analysis and enabling automation. A bioinformatic pipeline will analyse those genes pertinent to the specific tumour type requested. We will introduce molecular tumour boards to support the interpretation of results within MDTs. The oncology teams will also consider the potential implications of IPFRs and increased referrals. The AWGL is under pressure to deliver a gene panel service for cancer patients from requesters and patients, and frequently receives enquiries about this type of service. Molecular Pathology services worldwide are offering similar, or more extensive gene panel analysis. The proposed short-term project should determine if this service model is feasible, and delivers the anticipated patient benefits.