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...
https://youtu.be/ZdUG0nMZA7M In this episode of The Rising Tide Podcast, Dr. Justin Zook, Co-Leader, Biomarker and Genomic Sciences Group at the National Institute of Standards and Technology (NIST) sits down with the Center For Genomic...
Problem: How can YOU maximize value in precision medicine? Is precision medicine truly precise? The American Journal of Clinical Pathology recently published an article stating that only 37% of NGS oncology clinical labs reported ALL important mutations in their...
Patients deserve accurate genetic or genomic test results
Patients deserve accurate genetic or genomic test results