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CAP Proposes Improved Oversight of Lab-Developed Tests
Date:9/24/2009

a long history of advancing patient care as safe and effective laboratory services," Schwartz said. "Strengthening their oversight ensures they will remain one of the key tools medical laboratories use to answer increasingly complex questions."

Additional materials, including the Public Statement, and Frequently Asked Questions are available on the Advocacy tab at www.cap.org.

The College of American Pathologists is a medical society representing more than 17,000 physician members with programs and services for patients, clinicians, and the worldwide laboratory community. It is the largest organization composed exclusively of board certified pathologists and is widely considered the leader in laboratory quality assurance.


                         College of American Pathologists
                     Laboratory-Developed Test Oversight Model


    Classification     Determining           Oversight           Examples
                         Factors
    -------------- -------------------   -------------------     ---------

    Low            The test result is    The laboratory          Cytokeratin
    Risk           often used in         internally performs     Fragile X
                   conjunction with      and reviews validation
                   other findings to     prior to offering for
                   establish             clinical testing.
                   diagnosis.

                   No claim that test    The accreditor during
                   result indicates      the normally scheduled
                   prognosis or          inspections will
                   direction of          verify that the
      
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SOURCE College of American Pathologists
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