Transcript CAP Proposal: Oversight of Laboratory Developed Tests

Advocacy
FDA: Challenges to
Protecting Public
Health – Pathology’s
Perspective
Roger D. Klein, M.D., JD, F.C.A.P.
March 7, 2013
cap.org
v. FNL
Shared Goals
• Ensure patient access to high quality testing
• Assure that tests being offered are analytically and
clinically valid
• Leverage resources to maximize patient safety and
enhance public health
• Encourage innovation and continued improvement
of Laboratory-Developed Tests
© 2012 College of American Pathologists. All rights reserved.
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Evolution of Pathology
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Personalized Medicine
• Linking Tests to Action and Therapy
Assessment
Test
Action
Therapy
“The Right Drug for the Right
Patient at the Right Dose”
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4
Companion Diagnostics Model
• Today’s Paradigm
o One test, one drug
• Emerging Reality
o Tumor marker profiles guiding rational targeted
therapy combinations
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Current Situation
Regulation of Test Manufacturers
FDA
??? LDT ???
CMS
Regulation of Clinical Testing Laboratories
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Laboratory Developed Test
• A test developed within a CLIA-certified laboratory
that is used in patient management and has both of
the following characteristics:
o The test is performed by the clinical laboratory in
which the test was developed; and
o The test is neither FDA-cleared nor FDA-approved
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CAP Approach
• Oversight of LDTs should be strengthened through a
partnership between CMS, FDA and 3rd Party
Accreditors
• Analytic and clinical validation of these tests
require oversight and continued monitoring
• Oversight should be stratified based on risk
• Our approach recommends targeted FDA review of
only high-risk LDTs
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The CAP Paradigm for LDTs…
LDT #1
LDT #2
LDT #3
Low Risk
Mod Risk
High Risk
Laboratory
Validates &
Places in
Service.
Accreditor
Inspects.
Laboratory
Validates.
Accreditor
Reviews
Before Test
Placed in
Service.
© 2012 College of American Pathologists. All rights reserved.
Laboratory
Validates.
FDA
Reviews
Before Test
Placed in
Service.
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Risk Classification Principles
Classification
Principles
Low
•Test result is typically used in conjunction with other
clinical findings to establish or confirm diagnosis.
•No claim about test result alone determines prognosis
or direction of therapy.
Moderate
•Test result is typically used for diagnosis, predicting
disease progression or identifying whether a patient is
eligible for a specific therapy.
•Laboratory may make claims which determine
prognosis or direction of therapy.
High
•Test result predicts risk, progression of, or patient
eligibility for a specific therapy; AND
•Test uses proprietary algorithms or computations such
that the test result cannot be tied to the methods used,
or inter-laboratory comparisons can not be performed.
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CAP LDT Validation Principles
• The Proposal informed by evidence-based review
and incorporates FDA and CLIA principles.
o Ensures analytical and clinical validity and
consistency of claims with intended use;
o Least burdensome and achievable for
laboratories
− Field tested to validate principles
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Elements of CAP LDT Validation
Defining the
Disorder/Test/Clinical
Scenario
Analytical Validity
• Encompasses the development stage of
an LDT and serves to establish a testing
procedure and identify the intended use
of the test.
•The test’s ability to accurately and reliably
measure the analyte of interest in the clinical
laboratory, and in specimens representative
of the population of interest.
• The ability of a test to diagnose or predict risk
Clinical Validity
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for a particular health condition, measured by
clinical (or diagnostic) sensitivity, clinical (or
diagnostic) specificity, and predictive values.
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Conclusion
The CAP approach to oversight of LDTs will
ensure patient access to high quality testing,
preserving innovation while maximizing
patient safety and enhancing public health.
© 2012 College of American Pathologists. All rights reserved.
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© 2012 College of American Pathologists. All rights reserved.
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