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2018 Issues

Inside the Color Atlas of Mycology: Candida famata

November 2018—Color Atlas of Mycology: An Illustrated Field Guide Based on Proficiency Testing is a new book from CAP Press, released in October. It is designed to help in identifying fungi using the most recent taxonomic classifications. In it is more than 15 years of proficiency testing data to highlight diagnostic clusters of incorrect identifications and address conceptual classification issues. Following is an excerpt from the section on yeast.

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On Roche m 511 analyzer, ‘everything is done from the slide’

November 2018—Roche Diagnostics will soon launch its m 511 analyzer for hematology laboratories. Krista Curcio, Roche technical marketing manager, hematology, told us, in a recent conversation with CAP TODAY publisher Bob McGonnagle, how and why the new instrument is different. “We’re turning it upside down and going a different way,” she said of the m 511. Here is more on the instrument Roche will launch before year’s end.

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Put It on the Board

Quest acquires PhenoPath
November 2018—Quest Diagnostics has acquired PhenoPath Laboratories, which provides immunophenotyping, hematopathology, and molecular pathology services. The PhenoPath business, in Seattle, will operate as part of AmeriPath, a wholly owned business of Quest. Steve Rusckowski, Quest chairman, president, and CEO, said in a statement: “PhenoPath has a strong record of innovation and provides several capabilities that complement and extend our own, particularly in pathology and molecular oncology. It also deepens our presence in the Pacific Northwest.” PhenoPath founder Allen Gown, MD, tells CAP TODAY that continued consolidation in the laboratory industry and insurance reimbursement challenges have posed significant risks to PhenoPath’s future growth. “In Quest/AmeriPath,” he says, “we found an organization that realized not only the excellence of PhenoPath’s past and present but also the extraordinary future that, with their assistance, we can have.” Dr. Gown founded PhenoPath in 1998.

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How Henry Ford core lab uses bottom-up communication November 2018—When Henry Ford Health System started planning its core laboratory’s automation line four years ago, aware that it needed to take Lean to the next level, it enlisted frontline laboratory employees in a development process that used the strategies of Hoshin Kanri and kaizen. Read more.

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Clinical pathology selected abstracts

Preparing for passage of regulatory requirements for laboratory-developed tests: November 2018—The FDA has raised concerns, in recent years, about several high-risk laboratory-developed tests (LDTs), including a concern that patients may undergo unnecessary treatment or delay or forego treatment due to the inaccuracy of such tests. Other agencies have also challenged the validity, accuracy, oversight, and safety of LDTs, a subset of IVDs that are intended for clinical use and designed, manufactured, and used within a single laboratory.

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Anatomic pathology selected abstracts

November 2018—HER2: a pan-cancer event highly enriched in AR-driven breast tumors: Approximately one in five breast cancers is driven by amplification and overexpression of the HER2 receptor kinase, and HER2 enriched is one of four major transcriptional subtypes of breast cancer. The authors conducted a study to understand the genomics of HER2 amplification independent of subtype, as well as the underlying drivers and biology of HER2-enriched (HER2E) tumors.

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