By Kirell Lakhman

If it wants to break existing "barriers" to clearing molecular diagnostics, the FDA should focus on three things: developing "consistent and clear regulatory pathways" for regulatory submissions; providing universal standard references; and establishing a biorepository of rare specimens.

That was at the core of a presentation AMP made last week during FDA's CDRH Council meeting. The meeting, called Medical Device Innovation: Barriers to Market for Molecular Diagnostic Tests, was called to help the agency "identify and remove barriers to innovation and progress in transitioning basic and transitional research findings into routine clinical practice."

For its part, AMP identified three barriers that "impede the path to FDA clearance or approval for diagnostic tests and reduce the motivation to submit some medically useful tests for review:"

The "perception" among test makers that regulatory pathways for regulatory submissions are "inconsistent and unclear; the "paucity of standard reference materials for all areas of molecular diagnostics;" and the "difficulty of obtaining rare specimens for studies."

Describing the need for better regulatory pathways, AMP said test makers "have faced uncertainty and/or inconsistency in the review of device submissions, in enforcement discretion, in device classification, in requirements for acceptable analytical and clinical validations, and in requirements changing from the time of pre-IDE meetings through mid-trial."

If the FDA is interested in erasing this "perception," it "should ensure that policies and requirements are consistently applied, and that the scientific evidence and rationale for decisions are communicated effectively to diagnostic test manufacturers." An FDA-sponsored public meeting scheduled to take place next month may play an early role in helping to meet this request.

Additionally, "communication from FDA to diagnostic test manufacturers should be as clear and as comprehensive as possible at the outset of the submission process," AMO said. This "will help manufacturers better plan their resources and time. It will also assuage undue angst that the regulatory bar will change during the process."

Lastly, the FDA "should improve communication between government branches and agencies so that consistent requirements are developed and applied and demonstrations of clinical utility in one branch are recognized by the other branches;" and it "should involve the expert opinion of medical professional associations regarding clinical utility."

Discussing the need for standard references for genetic, cancer, and infectious-disease testing, AMP said not having them "inhibits the production of appropriate control materials and methods."

AMP claims it is "eager to see more progress and investments in this area," and said "FDA can assist by providing a list of needed standard reference materials to relevant organizations" such as the National Institute of Standards and Technology and World Health Organization."

Describing the challenge of obtaining rare specimens, AMP urged the FDA "to establish a biorepository of clinically relevant infectious agents, including strain variants and subtypes, to facilitate the rapid development and validation of assays for infectious agents, particularly those with pandemic potential."

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