The Association For Molecular Pathology Releases Position Statement On Oversight Of Laboratory Tests

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health;  Biology / Biochemistry
Article Date: 30 Jan 2010 - 0:00 PDT

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The Association for Molecular Pathology (AMP) has 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:

• Laboratory directors or medical directors should review and reaffirm their policies and procedures for reviewing and documenting that appropriate validation studies have been performed for all tests developed in their laboratories with due consideration of clinical utility and clinical utilization.
  
  
• CLIA should reassess utilization of resources and enforcement capabilities in order to meet its current mandate. CLIA should strengthen its enforcement capabilities by hiring more inspectors and improve the training of its inspectors.
  
  
• To increase transparency, CMS should make information collected from laboratories in the CLIA program available and easily accessible to the public and other regulators.
  
  
• Proficiency testing is a requirement of certification. When a formal proficiency testing program is not available, laboratories must perform and document alternative assessments as directed by CLIA.
  
  
• Some tests may require greater scrutiny, such as those with hidden or nontransparent algorithms, and should be subject to additional review by regulators.
  
  
• All LDTs should be subject to the same oversight mechanisms, and molecular tests should not be unduly scrutinized.
  
  
• Any changes to the current oversight system should occur after a formal rule making process or statutory change.

Source: Mary Steele Williams
Association for Molecular Pathology

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