ASH Comments on FDA Draft Guidance for Laboratory Developed Tests

Feb 9, 2015

On January 30, ASH submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance on Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).

Historically, laboratory tests have been regulated by the provisions of the Clinical Laboratory Improvement Amendments (CLIA) and some state laws. In 1976, the FDA was given authority to regulate medical devices; however, it used its discretion to determine that LDTs, which are distinct from tests designed for use in multiple labs, were exempt from traditional medical device requirements. The Guidance Document proposes that FDA assert its regulatory authority and increase oversight of LDTs.

The vast majority of laboratory tests that are essential for diagnosis and management of patients with hematologic diseases would fall into the category of tests FDA is defining as LDTs. Thus, the Society is extremely interested in the FDA’s guidance on LDTs and its potential impact on patient care and future access to cutting-edge and possibly life-saving diagnostic testing.

ASH strongly supports the FDA’s mission of protecting public health by ensuring the safety and efficacy of human drugs, biological products and medical devices and commends FDA for recognizing the regulatory gaps that exist regarding laboratory developed tests. The goal of ensuring accurate and clinically meaningful test results in a transparent manner to both clinicians and patients is a goal shared by the members of ASH. At the same time, ASH wants to make sure that changes to the regulatory oversight of LDTs are not so burdensome and/or costly that patient access to needed diagnostic tests are curtailed or the development of new and unique tests are significantly stifled.

ASH, submitted comments to the FDA in response to the draft guidance; some of the key highlights are as follows:

  • ASH supports FDA’s risk-based approach to assessing its enforcement discretion of LDTs, but recommends that the focus of its efforts be on high risk tests.
  • ASH suggests that FDA utilize panels of experts to clearly define what constitutes high risk and then to determine what tests should be included in this category. Such panels should also be used to determine how best to evaluate test modifications.
  • ASH supports FDA’s recognition that enforcement discretion should be continued for certain tests, but we are concerned that the categories of “traditional” LDTs and “rare disease” LDTs as defined in the draft guidance are not reflective of the current practice of medicine. These definitions should be revised and a new category of low volume tests should be added as a category of tests subject to enforcement discretion.
  • ASH suggests that FDA and CMS fully evaluate the overlap between CLIA and FDA’s regulation of medical devices and not duplicate requirements on labs as it relates to LDTs. Consideration should be given to changes to CLIA as a better means to assess the quality of low and moderate risk LDTs.

Please visit the Testimony and Correspondence section of the ASH website to read the comment letter submitted by ASH to the FDA.