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CAP Proposes Improved Oversight of Lab-Developed Tests

Three-tiered approach would categorize new LDTs by potential risk

WASHINGTON, Sept. 24 /PRNewswire-USNewswire/ -- The College of American Pathologists today announced new recommendations for strengthening oversight of laboratory-developed tests (LDTs), proposing a three-tier 'risk-based' system that would protect patients by ensuring every laboratory developed test is reported to an oversight body, and instituting a graduated system of review based on a test's potential risk to patients.


"While the preponderance of laboratory developed tests present relatively low risk to patients, the increasing use and complexity of some LDTs underscores the need for increased oversight," said Jared N Schwartz, MD, Ph.D., FCAP, president of the College of American Pathologists. "CAP's risk-based model employs a public private partnership to address oversight of these tests in an inclusive, systematic way."

CAP's proposed changes would incorporate oversight of claims of clinical validity, and would specify scientific and regulatory standards to be applied to all LDTs. Risk would be determined based on claims made, potential risk to patients, and the extent to which its results could be used in the determination of diagnosis or treatment.

The College believes optimum oversight would be achieved by applying a risk-based classification (low-, moderate-, or high-) to every LDT; strengthening CLIA accreditation standards on labs using low- and moderate-risk LDTs, and requiring FDA review of all high-risk LDTs.

"Laboratory-developed tests (LDTs) represent some of the most innovative clinical testing being offered to patients today, and have 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

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
    -------------- -------------------   -------------------     ---------

    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.

                   No claim that test    The accreditor during
                   result indicates      the normally scheduled
                   prognosis or          inspections will
                   direction of          verify that the
                   therapy.              laboratory performed
                                         appropriate validation
                   The test presents
                   low risk to

    -------------- -------------------   -------------------     ---------

    Moderate       The test result is    The laboratory must     KRAS
     Risk          often used for        submit validation       HER2
                   predicting disease    studies to the
                   progression or        accreditor for an
                   identifying           external review prior
                   whether a patient     to offering the test
                   is eligible for a     clinically.
                   specific therapy

                   The laboratory may
                   make claims about
                   clinical accuracy
                   or clinical

                   The test has higher
                   risk to patients.

    -------------- -------------------   -------------------     ---------

    High           The test result       The laboratory must     Oncotype
    Risk           predicts risk,        submit a high-risk      Dx(R)
                   progression,          test to FDA for review
                   patient               prior to offering the
                   eligibility for a     test clinically.
                   specific therapy,

                   The test uses
                   algorithms or
                   computations such
                   that the test
                   result cannot be
                   tied to the
                   methods used; or
                   comparisons can
                   not be performed.

                   The test poses
                   significant risk
                   to patients.

SOURCE College of American Pathologists
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