To advance the field of molecular pathology, any new oversight policy should also work to address the barriers to test development. Specifically, AMP believes the recognition and implementation of advances in medical research may be hindered by a lack of certified reference materials and encourages the government to support the development of these materials at the National Institute of Standards and Technology. Dr. Lyon explained, "Molecular assays provide the cutting edge for many individualized therapies in oncology, transplantation, infectious disease and genetics, but the production of certified reference materials has fallen far behind the technical capabilities of these assays which are needed to ensure sensitivity, specificity and reproducibility of intra- and inter-laboratory test results."

A major hurdle for laboratories is the reimbursement of diagnostic tests. Escalating costs for test development, performance, interpretation and reporting, compounded with additional costs to satisfy new regulatory requirements could result in the elimination of important clinical tests. In considering revisions to the current oversight processes, AMP urged FDA to realize the potential ramifications on test availability due to economic considerations.

Lastly, AMP recommended that the FDA convene an external advisory committee composed of individuals with expertise in the relevant diagnostic areas to assist in identifying the appropriate risk classifications. Dr. Lyon said, "There is much debate in the community about the criteria used to group LDTs into low, medium and high risk categories. An external advisory committee would be a very valuable tool for the FDA as it works to make these determinations."

Dr. Lyon concluded, "As the FDA considers its approach to regulating LDTs, AMP encourages the agency to consider the unanticipated effects that significant modifications to the current oversight system could represent for clinical laboratories." These unanticipated effects include the possibility that laboratories may be compelled to discontinue services and/or potentially lose flexibility to rapidly introduce and continually improve tests, all of which would adversely impact delivery of effective care to our patients.

In holding this meeting, AMP believes that the FDA has taken an important step forward and AMP looks forward to partnering with the FDA and continuing to work with the Agency for the benefit of patients.

Source: Association for Molecular Pathology