Unlocking the Promise of Molecular Diagnostics

McKesson Health Solutions, March 16th, 2011

Executive Summary

Breakthroughs in medical therapies, devices and diagnostics have enabled us to live longer, better lives. Vaccines have eradicated what were once deadly and paralyzing diseases. Antibiotics have made the threat of many serious illnesses no more worrisome than the threat of the common cold. Thanks to specialty pharmaceuticals, even AIDS and many cancers can now often be managed as chronic conditions. All of these advances and countless others have had a profound impact on our lives and have led us one step closer to what’s possible next.

At this moment, we stand at the threshold of another exciting step in healthcare. The development of molecular diagnostics (MDx) is beginning to change the way healthcare works in fundamental and compelling ways. By uncovering expression patterns of the human genome, physicians can more accurately pinpoint potential disease states and recommend therapies that are tailored to a person’s unique genetic makeup or “molecular signature.” In some cases, MDx do more than help physicians diagnose illnesses; they indicate a course of treatment. These tests will help physicians avoid inappropriate therapies and adverse affects, and improve care with more precision than ever before.

However, we face serious barriers to the effective use of MDx today. Criteria for accepting them into standard medical care have not been established. Few participants in healthcare feel entirely comfortable dealing with a deluge of MDx questions, uses and reimbursement issues. Meanwhile, the number of new diagnostics continues to grow at an unprecedented rate. The creation of an organized registry that differentiates among tests and includes clinical, performance and use information presented in a convenient and user-friendly way to doctors, patients, labs and payers can speed the adoption and benefits of MDx integrated into clinical practice. The good news is that many organizations have strong proposals and approaches to address the many challenges we face. These efforts will eventually help us realize the full potential of MDx by making them easy to recognize, understand and use.

This paper details the barriers we face to the effective use of MDx, what’s being done to solve those issues, and our view of what more is needed to realize the full promise of MDx.

Unlocking the promise of molecular diagnostics 0311 final Unlocking_the_Promise_of_Molecular_Diagnostics_0311_Final.pdf