October 2018

  • Fresh incentive to look for Ph-like ALL

    October 2018—Cheryl Willman, MD, could hardly believe her eyes. She and her colleagues at the University of New Mexico, working with collaborators from across the U.S. in the NCI TARGET Project, had submitted 100 cases of high-risk pediatric acute lymphoblastic leukemia to British Columbia’s Cancer Agency for RNA sequencing to figure out why patients were doing so poorly, despite treatment with intensive chemotherapy. Now the results were in. Dr. Willman, the Maurice and Marguerite Liberman distinguished chair in cancer research and UNM distinguished professor of pathology, vividly recalls the scene.

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  • Thyroid during pregnancy: how it changes, how to test

    October 2018—How pregnancy affects normal thyroid function and thyroid function tests, and screening for thyroid disease during pregnancy, were the focus of a session at this year’s AACC annual meeting.

  • Dr. Geaghan

    New requirements for use and storage of liquid nitrogen, dry ice

    October 2018—Laboratory personnel safety is at the center of two new requirements and a revised requirement in the latest edition of the CAP accreditation program checklists, released in August.

  • Revenue cycle services: can they quell billing woes?

    October 2018—Envision a long stretch of roadblocks of all shapes and sizes, staffed by unsympathetic and ever-changing guards, with new roadblocks springing up all the time, and you’ll probably have a fix on how most laboratories have viewed billing, going back decades.

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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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  • Selected Pathology Abstracts
    Clinical pathology: RT-PCR detection of B. microti parasites using BMN antigens as amplification targets. Read more.
    Anatomic pathology: Analysis of ZC3H7B-BCOR high-grade endometrial stromal sarcomas. Read more.
    Molecular pathology: Cell-free DNA tumor mutational burden predicts efficacy of immune checkpoint inhibitors. Read more.

  • Q&A

    Q. How can one wisely apply GATA3 immunohistochemistry as a useful tumor marker in diagnostic surgical pathology? Read answer.

  • Newsbytes

    Innovation labs: different means to
    the same end

    October 2018—What’s the best way for a hospital to kill a health care improvement-related idea? Some say (tongue in cheek) send it to committees, meetings, suggestion boxes, or the like. Read more.

  • Click to view these CAP TODAY departments:
    President’s Desk
    Newsbytes
    Put It on the Board
    Marketplace

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CAP TODAY Recommends

  • Precision medicine conference for health network/hospital CEOs to take place Sept. 12–13

    Precision medicine strategies and successes in improving patient outcomes are key themes when hospital and health network CEOs and administrators gather in Nashville Sept. 12–13 to hear from innovators at Vanderbilt University Medical Center, Geisinger Health, Northwell Health, Moffitt Cancer Center, and Seattle Children’s Hospital, among others. “Precision Medicine for Hospital CEOs: What You Need to Know about Genetic Testing, Precision Medicine, and Population Health Management” (precisionmedicineforhospitals.com) will feature first-mover and early-adopter health networks sharing the strategies of their precision medicine programs and the patient care successes and outcomes. Keynote speaker is Jeffery Balser, MD, PhD, CEO of Vanderbilt University Medical Center, which is internationally recognized for its pioneering efforts to bring precision medicine into daily clinical care. Attendees will gain insight into the early successes of precision medicine at Vanderbilt and learn how the health care big data base at Vanderbilt is being used to inform population health initiatives while also guiding the care clinicians provide daily.

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  • Cancer Biomarkers Conference III

    Houston Methodist Department of Pathology and Genomic Medicine is presenting its Cancer Biomarkers Conference III, Sept. 15–16, at the Houston Methodist Research Institute. More than 20 speakers will cover topics such as updates on PD-L1 testing for lung cancer, urologic cancers, and melanoma, the current approach to using cytology specimens for biomarker testing, the oncologist’s approach to TKI therapy, and many more.

  • CMS national coverage decision on next-generation sequencing

    A new white paper titled “The CMS National Coverage Decision on NGS” from Diaceutics provides coverage of ongoing developments since the NGS national coverage decision was made. Read the white paper (requires free registration).

  • VIDEO SERIES: The future of the lab in health care

    In a collaborative effort to discuss the future of the laboratory in health care, Bob McGonnagle, publisher of CAP TODAY, gathered with Orchard Software’s Curt Johnson, chief operating officer, and Matt Modleski, chief operating officer, American Health Network. This roundtable was edited into a series of seven short videos.

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Cytopathology

  • Cytopathology in Focus: Synergy in cytopathology and molecular microbiology

    August 2018—In today’s less-is-more world, health care consumers and providers often seek explicit and detailed information from minimally invasive procedures and tiny samples. Over are the days of “malignant cells present” and on to the next case. Cytopathologists and cytotechnologists are embracing and integrating novel techniques and applying new methods to the diagnosis and classification of essentially every imaginable form of neoplasia. The 2018 WHO publications confirm that 29 percent of deaths worldwide (more than 10 million people annually) are attributable to communicable diseases.1,2 This means the purpose of procuring many specimens is not to just rule out malignancy but also to diagnose infectious etiologies.

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  • Cytopathology in Focus: Why not call everything ASCUS?

    August 2018—Below is a question shared on the ASC listserv. My reply to the question follows. A pathologist colleague who practiced previously as an obstetrician/gynecologist is of the opinion that categorizing the level of abnormality we observe on a Pap test is a waste of time. All the clinician needs to know, he says, is whether the test is normal or abnormal. The Pap test is a screening test, he says correctly, and its only relevance is in pointing out who needs a colposcopy and biopsy.

  • Cytopathology in Focus: Cytology social media—Facebook and Twitter as networking tools

    August 2018—If you are not already using social media professionally, you may not know there is a vibrant and active community of pathologists, including many cytopathologists, on Facebook and Twitter—and getting involved is easy, fun, and educational.

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MARKETPLACE

  • Kurin specimen diversion technology

    October 2018—Kurin announced the results of clinical data from hospitals that use its FDA-cleared blood culture diversion device. In studies conducted at Crouse Hospital, Syracuse, NY, and Bayfront Health, St. Petersburg, Fla., the hospitals saw an overall reduction—56 percent and 54 percent, respectively—in contaminated blood cultures inclusive of all cultures drawn with or without the device. When a Kurin set was used in the blood collection, Crouse saw an 89 percent reduction in contaminated blood cultures and Bayfront a 90 percent reduction in contaminated cultures. In both cases, the hospitals were already below the three percent national contamination rate benchmark when they began using Kurin. Using the company’s passive diversion technology, the hospitals’ overall contamination rates decreased to 0.8 percent and 1.2 percent, respectively. The company has also released a five-minute documentary film titled Cry Wolf: The Consequences of Blood Culture Contamination. The film addresses the prevalence of blood culture contamination, the clinical impact on patients, and the steep associated costs for hospitals. Cry Wolf can be viewed at www.betterbloodcultures.com.

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  • FDA clears Techlab H. pylori tests

    October 2018—Techlab received FDA 510(k) clearance for its H. Pylori Quik Chek and H. Pylori Chek tests. The tests aim to offer quick and reliable detection of Helicobacter pylori–specific antigen in human fecal specimens.

  • Beckman files 510(k) for Early Sepsis Indicator

    October 2018—Beckman Coulter filed a submission for 510(k) clearance with the FDA for its Early Sepsis Indicator, offered as part of a standard CBC with differential test.

  • OGT expands sales support in Europe

    October 2018—Oxford Gene Technology announced it is selling its Cytocell fluorescence in situ hybridization products through several affiliates of Sysmex Corp. in Europe. “The move is a testament to the ongoing successful integration of the two companies and commitment to combine efforts to support and serve end users,” according to a press release from OGT.

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