Bethesda, MDJanuary 28, 2010 Today, the Association for Molecular Pathology (AMP) released its new position statement on the oversight of laboratory developed tests (LDTs), a recent focus of debate among policy makers, the laboratory community and other stakeholders. AMP's statement outlines the organization's commitment to providing high quality tests and its recognition of the need for implementation of appropriate oversight mechanisms. The association also met with officials from the United States Food and Drug Administration tasked with reviewing applications for diagnostic devices to inform them of the new position statement and discuss FDA's approach to regulating tests.
In recent years, there has been increased attention on the oversight of LDTs among policy makers, manufacturers, regulators and the laboratory community. While AMP believes that current mechanisms are sufficient in ensuring patient safety and broad access to high quality tests, AMP is taking this opportunity to elucidate its position on the issue.
"We believe that laboratory developed tests are an essential and central component of clinical care," said AMP President Dr. Karen Mann. She continued, "There is no evidence that the current oversight system has been inadequate or that there have been systemic problems."
In its position statement, AMP highlights that laboratories performing molecular tests are subject to the Clinical Laboratory Improvement Amendments and all laboratory directors are extensively trained professionals who adhere to all training requirements, certifications, licensure, and other regulations. Dr. Mann stressed the need to foster innovation, "As policymakers, regulators, and other stakeholders consider modifying the current oversight process, AMP urges them to ensure continued patient access to testing." AMP calls for stakeholders to avoid proposals that would hinder innovation in diagnostics, slow the rapid development and modification of necessary tests and impede the practice of medicine as all specialties rely on diagnostic tests.
AMP's specific recommendations include:
|Contact: Mary Steele Williams|
Association for Molecular Pathology