Molecular Diagnostics (Drugs) Advisory Group

Cancer Molecular Diagnostics (Drugs) Advisory Group

Predictive molecular diagnostic testing is currently provided in a number of public hospital locations and is used to inform specific drug treatment.  Molecular diagnostics allows certain cancers to be treated based on their genetic profile and can be used to determine the success of cancer treatment and in selecting treatment regimes for particular cancers.

The NCCP established a group to advise on the relevant cancer molecular diagnostic testing requirements. A Test Proposal Form is available for new test submissions (test predictive for drug treatment) for consideration by the Molecular Diagnostics (Drugs) Advisory Group. The recommendation form is completed by the advisory group following the consideration of a Test Proposal Form. The advisory group makes recommendations to the NCCP on the clinical validity, analytical validity and clinical utility of tests, and these recommendations inform the NCCP on deciding which tests should be supported on a national basis.

NCCP Framework for Decision Making for Tests (Predictive for Systemic Anti-Cancer Therapy Treatment) in the Irish Molecular Pathology Service

This document provides a framework for ensuring that decisions relating to the classification and declassification of cancer molecular diagnostics tests, predictive for Systemic Anti-Cancer Therapy (SACT),in the Irish molecular pathology service as it relates to oncological and haematological malignancies in the Irish public health service are reasonable, transparent and justifiable. The framework is used to appraise the evidence on the efficacy and effectiveness of tests.

Appendix 2 - Testing Proposal Form

As outlined in the National Cancer Strategy 2017 (Department of Health, 2017) the NCCP’s Cancer Molecular Diagnostic (SACT) Advisory Group identified the need for a framework outlining a decision making process to agree to appropriate tests ensuring molecular diagnostics predictive for SACT for cancer is carried out in a coordinated and standardised way. This included the development of a Test proposal form (Appendix 2). The Test Proposal Form should be completed by the referring clinical user in partnership with one or more local Molecular Pathology Laboratories where applicable. The form should be submitted to the Cancer Molecular Diagnostics (SACT) Advisory Group for consideration by emailing completed forms to oncologydrugs@cancercontrol.ie

Appendix 3 - List of Molecular Tests

List of molecular tests predictive for drug treatment performed or out sourced in Ireland (Based on responses from hospitals to NCCP survey 2018)