Among a number of trends and issues that will keep clinical laboratorians busy in the coming year is the ongoing discussion about how to regulate tests and procedures that are designed, manufactured, and used in a single laboratory—so-called laboratory-developed tests (LDTs).
FDA continues to assert its authority to undertake the regulation of LDTs. In October 2014, the agency published two proposed guidance documents on the regulation of LDTs.1,2 And in January of this year, it hosted a two-day workshop that resulted in airing a wide variety of viewpoints among stakeholders in the clinical laboratory community.3 In April, the agency joined with the Centers for Medicare & Medicaid Services to form a task force on quality requirements for LDTs.4
Most recently, FDA has gone on the offensive against stakeholders who have asserted that FDA regulation of LDTs is unnecessary because the tests can be sufficiently regulated under the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). In a publication circulated prior to a November 17 hearing before the House Energy and Commerce Committee’s subcommittee on health, FDA identified a number of serious concerns that it expects new regulations to address:5
- Lack of evidence supporting the clinical validity of tests.
- Deficient adverse event reporting.
- No premarket review of performance data.
- Unsupported manufacturer claims.
- Inadequate product labeling.
- Lack of transparency.
- Uneven playing field.
- Threats to the scientific integrity of clinical trials.
- No comprehensive listing of all LDTs currently being used.
It is too soon to tell what the final shape of LDT regulations might be—or even which agencies might emerge to administer the regulations. But in the meantime, laboratorians can undertake a number of steps to make sure that the tests they offer do not encounter the problems of inconsistent quality and performance that have attracted FDA’s attention in the first place.
One important thing that labs can do is to ensure that the components they use in developing and performing LDTs are themselves consistent in quality and other attributes necessary to produce an accurate report. This Buyer’s Guide lists more than 350 companies with specialty interests in fields related to clinical laboratory medicine—including manufacturers of finished tests and instruments as well as suppliers of every type of component from antibodies and reagents to robotics and software systems. Making sure to use the products of such qualified vendors is a major first step to ensuring that a laboratory’s tests will perform as specified and will not run afoul of regulatory requirements—whatever they may become in the future.
Chief Editor, CLP
- Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) [Framework Guidance]. Silver Spring, Md: Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, FDA, 2014. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416685.pdf. Accessed February 19, 2015.
- Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) [Notification Guidance]. Silver Spring, Md: Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, FDA, 2014. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416684.pdf. Accessed February 17, 2015.
- Public Workshop: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). Bethesda, Md: FDA, January 8–9, 2015. Transcripts available at: http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM431392.pdf [Day 1]; and http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM431422.pdf [Day 2]. Accessed February 17, 2015.
- Shuren J, Conway PH. FDA and CMS form task force on LDT quality requirements. FDA Voice [online]. Silver Spring, Md: FDA, 2015. Available at: www.blogs.fda.gov/fdavoice/index.php/2015/04/fda-and-cms-form-task-force-on-ldt-quality-requirements. Accessed November 24, 2015.
- The public health evidence for FDA oversight of laboratory-developed tests: 20 case studies. Silver Spring, Md: FDA, 2015.