June 20, 2023 The Test Wisely transparency survey was received June 1st, 2023.  As promised, as of today, June 20th, 2023, updates on the labs that have responded to CGI are as follows: Communication Received that the Laboratory is Working on Completing the...

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...

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...

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...

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...

Problem:   Understanding Polygenic Risk Scores (PRS) clinical utility and limitations can be a significant challenge. Solution:   An evaluation of clinical evidence and laboratory validation data will assist you in identifying the most accurate and...

Problem:   There are systematic problems with accuracy in CLINICAL GENETICS & GENOMICS.   Also, accustomed to self-policing, the genetics and genomics lab community express concerns about quality threshold requirements from insurance...