“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 [Laboratory Developed Tests] may identify different patient populations for targeted therapy.”
“The Pilot showed differences among NGS LDTs with respect to the correct identification of SNVs and MNVs, both with respect to one another and to the published accuracy of the model CDx.”
“The differences in preanalytic variables, variant identification, and reporting indicate that the LDTs of participating laboratories…may not be interchangeable with an FDA-approved CDx for identification of patients as candidates for gene-targeted therapy”
The post 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 appeared first on Center for Genomic Interpretation.
“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”
The post 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 appeared first on Center for Genomic Interpretation.