Laboratory Developed Tests: Ground Zero in the Push Towards Personalized Medicine

For the many patients who suffer from rare or complex conditions, the certainty that comes from knowing a diagnosis and moving forward with a treatment plan is one of the most powerful – and personal – moments in health care. That certainty and clarity comes from the ground-breaking innovations underway in bringing new laboratory developed tests to millions of Americans across the country.

Laboratory developed tests (LDTs) are diagnostics that hospitals, academic, and clinical laboratories develop using the in-house expertise of the physicians, geneticists, microbiologists, biochemists and many other highly trained laboratory professionals. From monitoring patients’ sodium or glucose to detecting DNA variations from a single blood sample, LDTs are ground zero for building an effective care plan that is specific to the individual patient.

Importantly, these tests are often created to respond to unmet patient needs that arise where more comprehensive diagnostics are required. The need for LDTs becomes even greater as the health system tackles the most complex health challenges facing patients—such as the work underway as part of the Cancer Moonshot. To ensure patients can continue to benefit from these tests when they need them, there is a critical and urgent need for comprehensive reforms.

For example, Dr. Aaron Katz, chairman of urology at NYU Winthrop Hospital in Mineola, N.Y., noted in the Wall Street Journal that, a genomic test “is an extremely important diagnostic tool to help me identify patients who are best to go on to surveillance.” Because of these vital tests, providers are able to distinguish between less aggressive cancers that may only need monitoring and more aggressive disease that may need surgery, radiation, or other treatment. With nearly 165,000 new cases of prostate cancer a year and about 29,000 deaths from the disease, the ability to develop more personalized and improved treatments mean that men with prostate cancer can live longer and higher quality lives.

Given the critical role these tests play in care delivery, a broad group of more than 80 leading health care companies and organizations representing patients, providers, laboratories and diagnostic manufacturers, including ACLA, called on Senate and House leaders to advance legislation that would reform and modernize the process for bringing innovative diagnostics to market.

At a time when consensus is often in short supply, the unified call to action represents the first time manufacturers, providers, labs, and patient groups have come together to urge policymakers to prioritize clinical diagnostic regulatory reform in 2018. Given the work underway from leading Congressional committees as well as the work from Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO), there is a far greater urgency to finalize the work that has been started to ensure patients continue to benefit from the LDTs that make a difference in their health. A modernized framework for LDTs presents a pathway forward for the next generation of patient care and personalized medicine. We stand ready to work with Congress to make that a reality.

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