AMP recommends PGx alleles for genotyping testing for warfarin response
July 2020—The Association for Molecular Pathology published in May consensus, evidence-based recommendations to aid in the design, validation, and interpretation of clinical genotyping tests for the prediction of warfarin response.
The new guideline on clinical warfarin sensitivity genotyping allele selection completes a series of three reports intended to facilitate testing and promote standardization for frequently used pharmacogenetics genotyping assays. Developed by the AMP PGx Working Group with organizational representation from the CAP and the Clinical Pharmacogenetics Implementation Consortium, the latest report (https://doi.org/10.1016/j.jmoldx.2020.04.204) builds on the earlier recommendations for clinical CYP2C19 and CYP2C9 genotyping. The recommendations should be implemented together with other clinical guidelines such as those issued by the consortium, which focus primarily on the interpretation of PGx test results and therapeutic recommendations for specific drug-gene pairs.
Similar to the previous reports in the series, this new warfarin genotyping guideline offers a two-tier categorization of alleles that are recommended for inclusion in clinical PGx genotyping assays.
New Qiagen panels launched at ASCO
Qiagen showcased its Sample to Insight solutions for cancer in connection with the American Society of Clinical Oncology annual meeting, held virtually in May.
The new QCI Interpret One software solution is now part of Qiagen’s Clinical Insights portfolio. QCI Interpret One delivers variant- and disease-specific evidence for every variant in any somatic panel, backing each classification with the latest peer-reviewed publications, oncologist-reviewed interpretation summaries, and an “expert second opinion.”
The new QIAseq Pan-cancer Multimodal (1.44 Mb, 605 gene) panel for comprehensive genomic profiling of solid tumors and hematologic malignancies leverages the Multimodal technology that begins with a total nucleic acid extraction and is followed by simultaneous preparation of DNA and RNA libraries. The Pan-cancer panel enables the detection of DNA and RNA aberrations and known and unknown RNA fusions, in addition to assessment of tumor mutational burden and microsatellite instability status in multiple sample types from a single sample input.
Qiagen also launched its QIAseq Targeted Methyl panels for targeted methylation analysis. The solutions offer faster one-day workflows and data analysis pipelines for predesigned and custom-tailored panels in a range of cancer applications, designed for low-input samples including liquid biopsy and those that are formalin-fixed, paraffin-embedded.
Sysmex launches XF-1600
Sysmex America on June 17 announced the availability of its XF-1600 flow cytometer.
The XF-1600 works in tandem with Sysmex’s PS-10 Sample Preparation System to automate the entire process of antibody staining, incubation, and flow cytometry analysis. “Highly trained operators no longer have to spend hours manually pipetting, leaving valuable time for more complex activities,” Andy Hay, chief operating officer of Sysmex America, said in a statement. It is available now in the United States and Canada.
FDA approves Cobas EZH2 Mutation Test as CDx
The Food and Drug Administration approved the Cobas EZH2 Mutation Test as a companion diagnostic for Tazverik (tazemetostat), developed by Epizyme. This molecular test detects abnormalities in the EZH2, or enhancer of zeste homolog 2, gene in patients with follicular lymphoma. It is expected to be available in the U.S. later this year.
‘A new level’ of collaboration between CAP, IARC
The CAP and the International Agency for Research on Cancer, part of the World Health Organization, signed a memorandum of understanding to strengthen their collaboration on the WHO Classification of Tumours Series and the CAP cancer protocols.
As part of the memorandum of understanding, the IARC allows the CAP to use the classification structure of the WHO Blue Books in the cancer protocols and electronic cancer checklists.
In addition, the CAP and the IARC will nominate representatives to each organization’s group that is responsible for maintaining and updating its resources—the CAP Cancer Committee and the WHO Classification of Tumours editorial board.
The IARC has named Ian Cree, BMSc, MBChB, PhD, FRCPath, head of the WHO Classification of Tumours program at the IARC, as its representative to the CAP Cancer Committee. Joseph Khoury, MD, of the University of Texas MD Anderson Cancer Center and chair of the CAP committee, will be nominated to the WHO Classification of Tumours editorial board.
“This is a big step forward,” Dr. Khoury said in a statement, “and will take the collaboration between IARC and CAP to a new level by further strengthening the alignment of our respective publications.” The two organizations will work together to share progress on timelines for new editions and updates to each organization’s publications, he added.
Latest on COVID-19
Editor’s note: See captodayonline.com for up-to-the-minute news on SARS-CoV-2 tests (in “Top News”), plus COVID-19 coverage that becomes available between print issues. A comprehensive list of FDA EUAs can be found at https://j.mp/fda-eua.