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In Every Issue

Put It on the Board

Therascreen EGFR RGQ PCR kit approved as companion diagnostic for Vizimpro October 2018—The FDA has approved a PMA supplement expanding the labeling claim of the Qiagen Therascreen EGFR RGQ PCR kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib). Vizimpro is for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or an exon 21 L858R mutation. The Therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also Gilotrif (afatinib) from Boehringer Ingelheim and Iressa (gefitinib) from AstraZeneca. It is registered in more than 40 countries. This was a project governed under an agreement between Qiagen and Pfizer.

Philips introduces computational pathology software for tumor detection Royal Philips announced in September the latest release of TissueMark, which the company says now supports region of interest detection for the majority of molecular testing.

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From the President’s Desk—CAP accreditation: perspective-taking 101

October 2018—I grew up in the CAP as a volunteer in the Laboratory Accreditation Program. It’s a good place to dive in. Many of us do what I did—work our way through many volunteer opportunities over 30 years or more because each was so interesting. There are an amazing number of ways a person can approach challenges in a laboratory; more amazing is how many of the approaches will work. Partly that’s because the learning cuts both ways—I’ve learned as much when we were inspecting another laboratory as when my laboratory was being inspected.

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Clinical pathology selected abstracts

RT-PCR detection of B. microti parasites using BMN antigens as amplification targets October 2018—Babesia microti infection, which is transmitted through the bite of an infected tick, is a growing health concern and continues to be a threat to the blood supply, with 22 states having reported cases of babesiosis in 2014. While most healthy adults with Babesia infection are asymptomatic or present with mild symptoms, including fever, fatigue, and anemia, babesiosis can be severe or fatal in neonates, the elderly, and immunosuppressed individuals.

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Anatomic pathology selected abstracts

Analysis of ZC3H7B-BCOR high-grade endometrial stromal sarcomas October 2018—High-grade endometrial stromal sarcoma likely encompasses underrecognized tumors harboring genetic abnormalities besides YWHAE–NUTM2 fusion. Triggered by three initial endometrial stromal sarcomas with ZC3H7B–BCOR fusion characterized by high-grade morphology and aggressive clinical behavior, the authors investigated the clinicopathologic features of this genetic subset by expanding the analysis to 17 such tumors. All of the tumors occurred in women who were a median age of 54 (range, 28–71) years.

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Molecular pathology selected abstracts

Cell-free DNA tumor mutational burden predicts efficacy of immune checkpoint inhibitors October 2018—Immune checkpoint inhibitors have emerged as a potent class of therapy for a variety of malignancies. The biologic rationale for these drugs is that somatic mutations, not necessarily in cancer driver genes, may accumulate in tumor cells, resulting in amino acid changes that create neoantigens (epitopes not present in normal cells during maturation of the immune system).

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Letters

AMH immunoassays October 2018—In the article “Satisfaction high with new automated AMH assays” (June 2018), the focus seems to be on the presumed advantages of the Roche Elecsys and Beckman Coulter Access automated anti-müllerian hormone assays over manual AMH assays. The article reports that the main advantages of the automated platforms are less variability in AMH measurements, greater assay turnaround time, and greater assay cost-effectiveness.

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Put It on the Board

Broad-based molecular testing for NSCLC September 2018—A recently published study on broad-based genomic sequencing and survival among patients with advanced non-small cell lung cancer in the community oncology setting should not lead to the conclusion that such sequencing should be avoided in nonsquamous NSCLC, say Paul A. Bunn Jr., MD, and Dara L. Aisner, MD, PhD, of the University of Colorado Denver, Aurora. Dr. Bunn, of the Department of Medical Oncology, and Dr. Aisner, of the Department of Pathology, in an editorial published Aug. 7 in JAMA, caution readers about the study published in the same issue, which found that broad-based sequencing (more than 30 cancer genes) directly informed treatment in a minority of patients and was not independently associated with better survival. The study of 5,688 patients with advanced NSCLC was based on data acquired through abstraction and aggregation of information from the electronic medical record from 191 U.S. community oncology practices.

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Q&A column

Q. Is there expert advice or standard practice for releasing preliminary critical values for patients to the LIS pending subsequent technologist or technician verification and documentation? Read answer. Q. We hope to validate a procedure for the fixation, decalcification, and staining of bone marrow specimens but we will not be able to access fresh marrow specimens for our decalcification validation. Can you recommend an alternative tissue to validate the preservation of tissue morphology and antigenicity after decalcification? Read answer.

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