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...
November 2022 – The Data Driven Point of View
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 clinically...
July 2022 – The Data Driven Point of View Special Edition Interview Newsletter: Justin Zook, Ph.D., Co-Leader, Biomarker & Genetic Sciences Group; National Institute of Standards and Technology (NIST)
Center For Genomic Interpretation (CGI) is very excited to share the interview edition of our monthly newsletter. Justin Zook, Ph.D. is the Co-Leader of Biomarker and Genomic Sciences Group at the National Institute of Standards and Technology (NIST). In the...
September 2022 – The Data Driven Point of View
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...
Medical Device Innovation Consortium (MDIC) Launching New Initiative for Somatic Reference Samples
The Medical Device Innovation Consortium (MDIC) is launching a new initiative testing somatic (tissue) reference samples to improve validation, as well as the regulatory review process for cancer diagnostic testing based on next generation sequencing (NGS). This will...
July 2022 – The Data Driven Point of View Special Edition Interview Newsletter: Justin Zook, Ph.D., Co-Leader, Biomarker & Genetic Sciences Group; National Institute of Standards and Technology (NIST)
Center For Genomic Interpretation (CGI) is very excited to share the interview edition of our monthly newsletter. Justin Zook, Ph.D. is the Co-Leader of Biomarker and Genomic Sciences Group at the National Institute of Standards and Technology (NIST). In the...
July 2022 – The Data Driven Point of View Special Edition Interview Newsletter: Justin Zook, Ph.D., Co-Leader, Biomarker & Genetic Sciences Group; National Institute of Standards and Technology (NIST)
Center For Genomic Interpretation (CGI) is very excited to share the interview edition of our monthly newsletter. Justin Zook, Ph.D. is the Co-Leader of Biomarker and Genomic Sciences Group at the National Institute of Standards and Technology (NIST). In the...
SPOT/Dx Pilot Publication; Pfeifer JD et al. Reference Samples to Compare Next-Generation Sequencing Test Performance for Oncology Therapeutics and Diagnostics. American Journal of Clinical Pathology 2022
“The data show that 7 (37%) of 19 laboratories correctly reported all variants for both wet and dry samples; [the FDA-approved test] also correctly reported all variants for both wet and dry samples” “Variable accuracy in detection of genetic variants among some...
August 2022 – The Data Driven Point of View
Problem: What exactly is a physician’s role and responsibility when testing patients for genetic abnormalities? The American College of Physicians (ACOP) recently released a position paper discussing just this issue. Precision medicine raises many issues...
August 2022 – The Data Driven Point of View
Problem: What exactly is a physician’s role and responsibility when testing patients for genetic abnormalities? The American College of Physicians (ACOP) recently released a position paper discussing just this issue. Precision medicine raises many issues...