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FDA Extends LDT Comment Period

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – The US Food and Drug Administration has reopened its comment period for the public and stakeholders to respond to its oversight plans for laboratory-developed tests until September 15.

FDA reopened the comment period, which initially closed on August 15, because it had received requests from stakeholders who wanted more time to develop or provide their opinions and recommendations on the issue.

The regulatory agency opened the public comment phase after a two-day meeting in July in which the agency’s Center for Devices and Radiological Health (CDRH) said that it may begin regulating certain LDTs that aren’t currently regulated and that it will start a collaboration with the National Institutes of Health to develop a test registry that would enable FDA to monitor test developers.

At the meeting, FDA also suggested that it may consider using third-party inspectors to help support its increasing regulatory burden.

The range of comments FDA has received so far include those that support the potential FDA oversight outright and others that are more skeptical and reflect the hope that there will still be time to work with the agency to keep its oversight plans from becoming overly complicated or burdensome.

Congresswoman Louise Slaughter (D – NY) wrote in support of the general oversight plan, and argued that FDA’s letters to direct-to-consumer companies notifying them that they are subject to oversight are a good first step but that the agency needs to do more.

In line with reports developed by the Secretary’s Advisory Committee on Genetics, Health, and Society, she recommended: establishing a consistent approach for reviewing the analytical validity of all emerging genetic testing technologies; adopting proficiency testing and quality assurance standards for labs performing genetic testing; research to determine clinical utility and to show how genetic testing affects health outcomes; educating and providing guidance to lab personnel, clinicians, and other healthcare professionals; maintaining ongoing public health surveillance to monitor the use of genetic tests, including a mandatory registry of genetic tests that includes health information; and coordinating public and private sector activities to develop requirements for establishing analytical validity, quality assurance, clinical validity, and clinical utility.

Winton Gibbons, senior VP of business development at the molecular diagnostics company Nanosphere, told FDA that using a common process for deciding clinical utility across all marketed diagnostic tests and lab services will improve patient safety, reduce confusion among doctors, hospitals, and patients, and would lead to lower healthcare costs.

Gibbons recommended that FDA policy should be based on science and should be consistent and dependable for all diagnostics providers. Studies that are used to prove the clinical utility of diagnostic tests should be well designed and scientifically and statistically valid.

Nanosphere thinks that FDA should create detailed guidelines for clinical studies and that it should serve as an objective third party that will make sure that clinical studies meet these guidelines.

Gibbons also said that risk assessments should be used to determine the level of evidence that these studies need to present, that there is a need for clinical studies that are purely observational and which do not intervene in diagnosis or therapy, and that there is a role for “humanitarian use exemptions” or exemptions for rare diseases.

Marie Landry, Director of the Clinical Virology Laboratory at Yale New Haven Hospital and a professor at Yale University School of Medicine, commented that the “value-added” of FDA oversight for viral lab-developed testing “is not apparent and [it] would likely be burdensome.”

“The laboratory is overworked. Additional regulatory burden for viral assays would be very detrimental and have a negative impact on patient care and cost,” Landry noted.

Clear and detailed guidelines from the Clinical Laboratory and Standards Institute for validating and monitoring assays and inspections and proficiency testing from the College of American Pathologists “should be sufficient” and would be of more benefit to labs, she wrote.

“Ready availability of universal standards would be very helpful as well,” she added.

Mary Ann McLane, president of the American Society for Clinical Laboratory Science, suggested that FDA oversight could lead to “enormous” benefits for labs.

“Laboratorians will be able to offer the latest, scientifically and clinically valid tests to their patients without having to develop the tests themselves. There is an urgent need for a process that brings translational research to the clinical laboratory for our patients’ benefit,” she commented.

Ideally, McLane urged, FDA would look to the guidance written for in vitro diagnostic multivariate assays and form a similar structure for LDTs, and she asked that FDA consider oversight for LDTs that affect diagnosis and treatment of pathological and genetic conditions.

McLane acknowledged that there may be challenges for labs trying to meet any new FDA oversight rules and that they could be a drag on innovation, but also said that if the tests are good then labs will learn to work with oversight.

“Clinical laboratories are going to struggle with FDA’s terminology and approval processes because most have never even heard of them much less submitted anything for FDA approval,” she continued.

“There is no question that increased oversight will slow innovation. However, as clinical laboratories learn the systems, LDTs based on real science should have no problem gaining FDA approval,” she added.

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