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November 2018


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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Molecular pathology selected abstracts

November 2018—Common genetic variants contribute to risk of rare severe neurodevelopmental disorders: The traditional paradigm broadly classifies genetic diseases into rare disorders caused by a single gene variant and common disorders caused by complex interplay among multiple genes. However, recent research has shown that penetrance and disease phenotype, even in disorders thought to be monogenic, are affected by common genetic variation.

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Letters: Ph-like ALL

November 2018—In the October issue of CAP TODAY, Karen Titus shared with us a story titled, “Fresh incentive to look for Ph-like ALL.” She spoke with key players in the discovery of BCR-ABL1-like B-lymphoblastic leukemia/lymphoma (B-ALL) (or “Ph-like” ALL), which is now a provisional entity in the 2016 revised fourth edition of the WHO. A key takeaway from the article ...

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AMP case report: October 2018 test yourself answers

In the October 2018 issue was a case report (page 70), “NGS in the diagnosis of RASopathies in histologically uninformative skin biopsy samples,” written by members of the Association for Molecular Pathology. Here are answers (in bold) to the three “test yourself ” questions that followed that case report. 1. Which of the following is the most commonly mutated gene in ...

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