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Minimum set of alleles recommended for clinical CYP2C9 genotyping

June 2019—A joint report from the CAP and the Association for Molecular Pathology was published last month to aid in the design and validation of clinical CYP2C9 assays, promote standardization of testing across different laboratories, and improve patient care. The report, “Recommendations for Clinical CYP2C9 Genotyping Allele Selection: A Joint Recommendation of the Association for Molecular Pathology and College of American Pathologists,” was released online ahead of publication in the Journal of Molecular Diagnostics (doi:10.1016/j.jmoldx.2019.04.003).

The AMP Pharmacogenetics Working Group is developing a series of guidelines to help standardize clinical testing for frequently used genotyping assays. Developed with organizational representation from the CAP and the Clinical Pharmacogenetics Implementation Consortium, the latest report follows a set of recommendations for clinical CYP2C19 genotyping allele selection published in May 2018. These reports define a minimum set of alleles/variants that should be included in clinical genotyping panels for two of the most important PGx genes.

“The AMP PGx Working Group started with CYP2C19 and CYP2C9 genotyping panels due to the widespread adoption of these tests and our desire to help physicians, pharmacists, researchers, and other stakeholders better understand what these ­panels include and what the test results mean,” Victoria Pratt, PhD, associate professor and director of pharmacogenetics and molecular genetics laboratories, Indiana University School of Medicine, said in an AMP statement. Dr. Pratt is AMP president and PGx Working Group chair.

The new report offers a two-tier categorization of CYP2C9 alleles as an aid for designing CYP2C9 genotyping assays.

FDA clears Aperio AT2 DX for clinical diagnosis

Leica Biosystems received clearance from the Food and Drug Administration to market its Aperio AT2 DX System for clinical diagnosis in the United States.

A multicenter study supporting this clearance was conducted at five clinical study sites: University of California Davis, Pacific Rim Pathology, Dignity Health, TriCore Reference Laboratories, and Intermountain Healthcare. The participating pathologists read approximately 16,000 cases.

The Aperio AT2 DX is a high-throughput automated scanning and viewing platform. It will be launched commercially with clinical image management software for an integrated digital pathology workflow solution.

Qiagen launches QIAstat-Dx

Qiagen launched in the U.S. its FDA-cleared QIAstat-Dx syndromic testing system with a respiratory panel that detects more than 20 pathogens.

The QIAstat-Dx (formerly Stat-Dx DiagCore) received CE-IVD marking in January 2018.

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