AMP Report Addresses MDx Challenges
News Aug 18, 2016
The Association for Molecular Pathology (AMP) has announced a new report that addresses the challenges in defining the clinical utility of molecular diagnostics for inherited diseases and cancer. The manuscript titled “The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology” has been released online ahead of publication in the September 2016 issue of The Journal of Molecular Diagnostics.
Molecular diagnostic procedures are used for a myriad of purposes including diagnosis, prognosis, risk assessment, prediction of future disease, and monitoring and selection of therapies of disease in patients. Future advancements in precision medicine are threatened by drastic shifts in evidence demands and the adoption of very narrow clinical utility definitions that do not address all the important applications of molecular diagnostic testing. Without a correction, treating clinicians could be left to make decisions without an accurate molecular diagnostic result and the clinically valuable information needed for patient management.
In the manuscript, the AMP Framework for the Evidence Needed to Demonstrate (FEND) Clinical Utility Task Force recommends clinical utility definitions that appropriately recognize the full contribution and value of molecular diagnostic testing to improve patient care. This approach emphasizes that a clinical test result’s utility depends on the context in which it is used to classify a patient’s disease or disorder and/or guide management. The authors also note that the recommendations can be extended to additional applications of molecular testing.
“Patient access to clinically useful and appropriate molecular diagnostic testing based upon realistic evidence levels is paramount and clinical utilities beyond therapeutic selection are valuable to patients, providers, and family members,” said Elaine Lyon, PhD, 2014 AMP President and FEND Task Force Co-chair. “Ultimately, we need to capture evidence for the clinical utility of molecular pathology procedures outside of a traditional randomized control trial setting, recognizing that any individual test result is an intermediate outcome that relies on proper clinical interpretation and utilization in context for that specific patient to achieve maximum benefit.”
“Molecular pathology testing procedures are vital tools for insight and analysis into various aspects of clinical practice,” said Roger D. Klein, MD, JD, AMP Professional Relations Chair. “However, we need a more practical and patient-centered approach for evaluating clinical usefulness before we can truly deliver the promise of precision medicine.”
A New, Streamlined Approach to Diagnosing and Treating Bowel CancerNews
Researchers at the South Australian Health and Medical Research Institute (SAHMRI) and the University of Adelaide have discovered a faster, more cost-effective way to determine which DNA mutations cause human bowel cancer.READ MORE
New Rapid-fire Method Using Pathology Images & Tumor Data May Help Guide Cancer TherapiesNews
By combining data on pathology images of 13 types of cancer and correlating that with clinical and genomic data, researchers are able to identify tumor-infiltrating lymphocytes, which will enable cancer specialists to generate tumor-immune information from routinely gathered pathology slides.READ MORE
A Novel Point-of-Care Assay Developed for Hepatitis CNews
Scientists from the Institut Pasteur and Inserm have developed and validated a rapid, reliable, point-of-care HCV assay.READ MORE