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AdvaMed Suggests Firms Should Provide Validated QC Materials To Labs

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers should be allowed to provide quality control materials for diagnostics to laboratories, AdvaMed says

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Diagnostics In Brief

Pathwork tumor test: Molecular diagnostic firm receives FDA clearance July 29 for its Pathwork Tissue of Origin Test, used to determine the origin of hard-to-identify tumors. The test uses an Affymetrix microarray, cleared along with the tumor test, to measure the uncertain tumor's gene expression pattern and compare it to a panel of 15 known tumor types, including bladder, breast and colorectal. Pathwork is finalizing details to make the IVD kit available later this year; the test is already available as a service through the firm's lab. The test is the second in vitro diagnostic multivariate index assay (IVDMIA) cleared by FDA, after Agendia's MammaPrint breast cancer recurrence test

Diagnostics In Brief

Pathwork tumor test: Molecular diagnostic firm receives FDA clearance July 29 for its Pathwork Tissue of Origin Test, used to determine the origin of hard-to-identify tumors. The test uses an Affymetrix microarray, cleared along with the tumor test, to measure the uncertain tumor's gene expression pattern and compare it to a panel of 15 known tumor types, including bladder, breast and colorectal. Pathwork is finalizing details to make the IVD kit available later this year; the test is already available as a service through the firm's lab. The test is the second in vitro diagnostic multivariate index assay (IVDMIA) cleared by FDA, after Agendia's MammaPrint breast cancer recurrence test

Proteomics And Genomics Are Forcing A Re-look At Test Validation Protocol

Test developers might need to adjust their approach to assay validation to facilitate adoption of some up-and-coming diagnostic technologies, several speakers suggested at an American Association of Clinical Chemistry meeting Oct. 25 in Washington, D.C

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