Personalized medicine, including the molecular diagnostic tests that provide information to your healthcare providers, may ultimately revolutionize cancer prevention, diagnosis, treatment, and follow-up.

Although there are many pathways involved in most tumors, making targeted therapy more complex than originally thought, this emerging approach continues to offer great promise, such as in the following:

• The ability to make more fully informed medical decisions
• Higher probability of desired outcomes
• Reduced probability of negative side effects
• Increased pro-active focus on prevention and prediction of disease rather than primarily reaction
• Earlier disease intervention than previously possible

But it is important that all stakeholders’ needs are met:

• Healthcare providers desire easy-to-access, easy-to-use molecular testing services.
• Payers require cost-effective options.
• Patients must receive the optimal treatments for themselves.
• We all need molecular testing to be reliable and of a high standard of quality to ensure accuracy and robust results.

CISN Summary

Molecular diagnostics are becoming important tools for cancer detection and subtyping. The expansion into the pharmacogenomics and therapy decision tree areas will have major implications for both industry and patients.

New technologies are needed to deliver greater sensitivity, faster turnaround, and smaller platforms (testing machines) if they are to become part of disease treatment monitoring as well as diagnostics. If this can be achieved, it will also open the door to move from the dedicated diagnostics laboratory to the physician’s office.

Molecular diagnostics are particularly applicable to:

• The early detection of cancer,
• Optimizing drug therapy by better defining a patient's need,
• Predicting clinical outcome from a specific drug, and
• Determining metastatic potential.

• National Cancer Institute. Understanding Cancer Series: Molecular Diagnostics:

http://www.cancer.gov/cancertopics/understandingcancer/moleculardiagnostics

• A more technical version of molecular diagnostics written by the CISN:

https://cisncancer.org/research/new_treatments/molecular_diagnostics/index.html

1. Tufts Center for the Study of Drug Development. Personalized medicine is playing a growing role in development pipelines. Impact Report: Analysis and Insight into Critical Drug Development Issues. 2010;12(6).
2. George Poste, David P. Carbone, David R. Parkinson, Jaap Verweij, Stephen M. Hewitt, and J. Milburn Jessup. Leveling the Playing Field: Bringing Development of Biomarkers and Molecular Diagnostics up to the Standards for Drug Development, Clin Cancer Res; 18(6); 1515–23. 2012 AACR.
3. One size does not fit all: the promise of Pharmacogenomics. Just the Facts: A Basic Introduction to the Science Underlying NCBI Resources, National Center for Biotechnology Information. Available online at:
   http://www.ncbi.nlm.nih.gov/About/primer/pharm.html
4. Tufts Center for the Study of Drug Development. Personalized medicine is playing a growing role in development pipelines. Impact Report: Analysis and Insight into Critical Drug Development Issues. 2010;12(6).
5. Excerpted from a talk by Karen Rasmussen, PhD, FACMG, Clinical Molecular Genetics. Maine Center for Cancer Medicine, Scarborough, Maine
6. Davis J, Ma P, Sutaria S. The microeconomics of personalized medicine. McKinsey Quarterly. Updated April 2009. Accessed July 26, 2011. Available online at:
   http://www.mckinseyquarterly.com/The_microeconomics_of_personalized_medicine_2527
7. Spear BB, Heath-Chiozzi M, Huff, J. Clinical application of pharmacogenetics. Trends Mol. Med. 2001;7(5):201-204.
8. Food and Drug Administration. FDA/CDRH Public Meeting: Oversight of laboratory developed tests (LDTs), July 19-20, 2010. Updated September 17, 2010. Accessed July 26, 2011. Available online at:
   http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm
9. George Poste, David P. Carbone, David R. Parkinson, Jaap Verweij, Stephen M. Hewitt, and J. Milburn Jessup, Leveling the Playing Field: Bringing Development of Biomarkers and Molecular Diagnostics up to the Standards for Drug Development, Clin Cancer Res; 18(6); 1515–23. _2012 AACR.

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“Content Developed September 1, 2012”