Leading a new generation of personalized medicine, LDTs must be key consideration in diagnostic reform

Lab developed tests (LDTs) are essential to health care delivery and the broader health system, helping pave the way for a new era of personalized medicine and making it possible to achieve national health goals like the Cancer Moonshot.

These vital tests are developed and performed by individual laboratories, providing reliable, early diagnosis for many rare and increasingly complex conditions. In many cases, LDTs are born from gaps in clinical needs.

Genomic testing only a few years ago was limited to patients with certain solid tumors (e.g. melanoma, lung cancer, and colon cancer). Today, targeted tumor-sequencing tests can be used for any tumor – regardless of where in the body the cancer started. This technology has the ability to screen hundreds of genes for cancer tumors in an unprecedented way, allowing providers to assess whether a tumor is susceptible or responsive to certain drugs. As a result, genomic testing guides better treatment or prevention options for patients when they first need it, avoiding trial and error to identify the best course of action.

Diagnostic science, technology, and innovation have advanced to a tipping point, but government oversight enacted decades ago has struggled to keep up. Instead of providing clear guardrails to innovators and assured paths for patient access, federal and state laws have begun to overlap and create unnecessary burdens, duplication, and even confusion. This overlap and confusion threatens to stifle continued medical diagnostic progress.

To ensure that high-quality, accurate, reliable, and innovative tests are reaching the patients who need them, the time has come for Congress to prioritize comprehensive reform to federal diagnostic oversight and support cutting-edge innovations that both patients and the health system depend on. Furthermore, Congress must undertake reforms such that any new diagnostic framework acknowledges the unique function, value, and workflow of LDTs. These highly-tailored tests continuously respond to emerging gaps in clinical care and cannot be regulated with a one-size fits all approach.

The good news is that Congress has already begun work to advance these reforms.  Leaders in Congress, particularly Rep. Diana DeGette (D-CO) and Rep. Larry Bucshon (R-IN), along with Sen. Michael Bennet (D-CO) and retired Sen. Orrin Hatch (R-UT), have been honing legislative proposals in collaboration with stakeholders and the Administration, beginning with the Diagnostic Accuracy and Innovation Act (DAIA), and more recently, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act.  Much work remains, however.

ACLA believes that reform must ultimately create a modernized, risk-based model for federal review that accounts for the full range of tests and diagnostics coming to market. Reform should also establish clear, objective standards and grandfathering provisions to guarantee patients can continue to access the life-saving tests they need during transitions to a new regulatory framework. These key provisions will help ensure both continued innovation and robust patient access to high-quality, accurate, and reliable clinical laboratory diagnostics.

As we move forward in 2019, Congress should build on the important work led by Rep. DeGette, Rep. Bucshon, Sen. Bennet and Sen. Hatch. We must advance meaningful and comprehensive solutions to bring the next generation of clinical innovation to patients. For the millions of patients and their families, it’s imperative that we get this right.

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