News
April/May 2023 – The Data Driven Point of View

April/May 2023 – The Data Driven Point of View

Access to guideline recommended biomarker testing continues to vary depending on the insurance payer and also from state to state. Legislation is passing in many states to guarantee insurance coverage of biomarker testing. This testing, if accurate, helps determine...

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March 2023 – The Data Driven Point of View

March 2023 – The Data Driven Point of View

PROBLEM: A government convened workgroup discovered that CLIA mandated proficiency testing is “too easy“. As a result, too many low quality labs with both CLIA & CAP accreditation are issuing too many inaccurate genetic & genomic test results, which are...

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Jan/Feb 2023 – The Data Driven Point of View

Jan/Feb 2023 – The Data Driven Point of View

Problem:   Many clinical genetic and genomic labs knowingly or unknowingly take inappropriate shortcuts that may ultimately lead to mistakes in their test validations.  These ‘mistakes’ can impact patient care and outcomes.  With LDTs not being regulated, they can go...

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December 2022 – The Data Driven Point of View

December 2022 – The Data Driven Point of View

Problem:  Verifying Accurate Leading-edge IVCT Development (VALID) Act is part of the December omnibus spending bill. If VALID doesn’t pass, how will LDTs be regulated to ensure patients are getting accurate results? Solution:   The FDA could use ‘Rulemaking’ to...

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