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How Do You Perform Pdl1 Testing within Your Own Institution
How Was the Decision Made To Use the Antibody Clone That You Selected
Some of the Challenges with Scoring Using Cps
Mesothelioma
Challenges
Additional Challenges
Any Key Takeaways about Teaching and Training Residents When It Comes to Pdo1
Specificity of the Stain
Validation
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2020/01/28The Fda Published a Proposed Rule To Regulate Laboratory Developed Tests as Medical Devices
Stage One
Where Does the Fda Actually Derive Its Authority To Regulate Tests from
How Are Laboratory Developed Tests Actually Used in Clinical Care
Public Comment
Regulatory Impact Analysis
The Fda Proposed Rule Has Information of Cost Estimates and Estimates about the Financial Benefits if the Rule Were To Become Final
The Proposed Rule Takes a Position That Manual Testing Is Safer than Automated Testing
Toxicology
Where Do You Foresee the Majority of the Expense Falling within the Various Stages or Years after the Rule Becomes Final
Definition of laboratory developed tests (LDT)
LDT is usually faster than FDA to provide access to clinical diagnostics
Regulation of LDTs
Burden of development rests with the laboratory
Example: Next Generation Sequencing in the US is done as LDT
Process for CLIA licensure
The start of patient testing
CAP accreditation, the gold standard for Laboratory Quality in the US
Summary