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April 2013:
Laboratory Accreditation / Education / CME


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Pathology Laboratory Accreditation: Laboratory-Developed Tests
Jaleh Mansouri, M.D.


Laboratory developed tests are diagnostic tests developed in house by pathology laboratories. These tests are usually comprised of a test kit including reference standards and analyte specific reagents (ASR) and are not subject to clearance or approval by the U.S. Food and Drug Administration (FDA) at the current time. Still, the performance characteristics (i.e. specificity and sensitivity) are subject to validation (e.g. proficiency testing) and must meet certain quality standards as defined by the College of American Pathologists (CAP) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) in order for the laboratory to maintain accreditation.

As the complexity of pathology laboratory developed tests continues to increase with the emergence of various molecular techniques (e.g. microarrays), some companies may voluntarily seek clearance or approval of certain tests by the FDA. One such example is MammaPrint (Agendia, Irvine, CA), the first in vitro multivariate diagnostic index assay (IVDMIA) to be cleared by the FDA. While such tests may fall under the regulatory jurisdiction of the FDA, the medical profession may be encouraged to utilize these high complexity tests based on their clearance/approval, a factor that may have financial or economic implications for the laboratory developing the test. Recent communications suggest that laboratory developed tests may eventually be required to be cleared or approved by the FDA as medical devices.






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Past / Future Feature Pages:

January 2013: Billing / Consulting / Management
February 2013: Microscopes / Microscopy Products
March 2013: Tissue Processors / Other Histology
April 2013: Laboratory Accreditation / Education / CME

May 2013: Computer Software and Systems
June 2013: Diagnostic Testing / Reagents
July 2013: Imaging / Digital / Photography
August 2013: Books & Journals
September 2013: Antibodies
October 2013: Laboratories
November 2013: Consumable Lab Products / Clinical Lab Analyzers
December 2013: Grossing Equipment / Workstations
January 2014: Billing / Consulting / Management
February 2014: Microscopes / Microscopy Products
March 2014: Tissue Processors / Other Histology
April 2014: Laboratory Accreditation / Education / CME

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