Andrew Fish, executive director of AdvaMedDx, testified before the U.S. House of Representatives Energy and Commerce Committee recently in support of FDA taking a risk-based approach to the regulation of lab-developed tests (LDTs), which have grown increasingly complex over the last decade and are relied upon by doctors and patients to guide critical healthcare decisions.
In the written testimony provided to the committee, Fish said, “For years, stakeholders have recognized the inadequacy of current oversight of LDTs and called for FDA to enforce existing regulations that apply to LDTs just as they do to all other diagnostics.” Fish commended FDA for moving forward to address the patient safety gaps that currently exist in LDT oversight.
As diagnostics technologies and the laboratory business have evolved, even the most advanced tests – such as technically complex genetic tests that guide choices among cancer treatments – are now developed and offered by laboratories as LDTs. Current oversight of laboratories by the Centers for Medicare and Medicaid Services (CMS) under CLIA – the Clinical Laboratory Improvement Amendments of 1988 – is not a substitute for FDA regulation that assures the safety and effectiveness of diagnostic tests. Many critical features of FDA oversight have been absent for LDTs under the CLIA laboratory program and only FDA has the appropriate expertise and resources for necessary oversight of LDTs.
“A test is a test -- and presents the same risk for patients regardless of whether it is developed by a manufacturer or a laboratory. Potential harms to patients whose tests return incorrect results include unnecessary treatments, with their accompanying costs and side effects, and treatment delay or failure to obtain appropriate treatment, all of which present concerns for patient care,” said Fish.
“The current diagnostics oversight paradigm results in a tremendous public health gap and highly disparate treatment of tests that are the same from the perspective of patient risk and safety, simply on the basis of where they are developed. This is bad public policy, provides an opportunity to use tests in clinical settings that have insufficient clinical data, and stifles investment in high quality products that are assured safe and effective for patients.”
In August, AdvaMedDx praised FDA’s for its efforts to issue a draft risk based framework on LDTs and said it would review and comment on the draft guidance when it is issued.
AdvaMedDx’s membership supports a modernized and flexible approach to the review process for diagnostics. Such a review process should create a reasonable pathway to market and advance patient care by promoting timely access to innovative technologies.
AdvaMedDx member companies produce innovative, safe and effective in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, promote wellness, enable early detection of disease and reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is dedicated to the issues facing in vitro diagnostic companies both in the United States and abroad.