WASHINGTON – Today AACC released a position statement endorsing efforts within the healthcare community to improve patient outcomes by personalizing medical care. The statement emphasizes the central role that innovative laboratory tests play in precision medicine, and stresses the need for policymakers and insurers to adopt policies that ensure access to and appropriate reimbursement for these tests so that patients can benefit from targeted treatments.

The traditional healthcare model can be one of trial and error, where physicians prescribe a treatment and then wait to see if the individual patient will be among the percentage of patients who respond favorably to that treatment. This can result in many patients with serious medical conditions not receiving effective care. Studies show that 43% of the population does not respond to commonly prescribed drugs for diabetes and 75% do not respond to therapeutics for cancer. It is critical that the healthcare community move toward the model of personalized or precision medicine—the practice of tailoring treatment based on the results of genetic and other tests that identify which interventions patients will respond to best.

In the position statement, AACC details the challenges that policymakers must tackle before the field of personalized medicine can fulfill its potential. One major roadblock is that Medicare and other insurers do not cover many tests that are integral to personalized medicine because these tests are specific to diseases or conditions that affect small subsets of the population, making it difficult for test developers to amass sufficient data to comply with research requirements. AACC encourages all payers to develop clear and consistent evidence criteria for coverage of personalized medicine tests that account for the fact that these tests are intended for use in narrow population groups. While payers might initially encounter higher up-front costs associated with patient-specific testing, they will realize ultimate savings as a result of earlier, more effective care.

Innovation is also vital to the advancement of precision medicine. Laboratory developed tests, or tests that labs design in-house, enable healthcare teams to immediately personalize a patient’s treatment when a commercial test is not available. AACC encourages laboratory medicine professionals to continue to work with clinicians to develop novel tests that identify the most effective treatments for patients, and urges the Food and Drug Administration to craft regulations that promote this innovation.

“With the use of laboratory tests, healthcare professionals are increasingly able to identify and monitor precisely targeted, individualized therapeutic interventions that improve patient outcomes,” said AACC CEO Janet B. Kreizman. “To ensure the full benefits of this approach are realized, AACC urges payers to cover personalized medicine tests so that all patients can afford them.”


About AACC

Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.