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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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New accreditation program checklist section: Imaging mass spec scores its own quality standards

October 2018—It happened for next-generation sequencing. It was an important step for in vivo microscopy. And now it’s taking place with imaging mass spectrometry. The milestone: development and adoption of a set of specialized checklist requirements for laboratories that want CAP accreditation. Imaging mass spectrometry, an adjunct methodology to help pathologists analyze areas of interest in tissue specimens, is, at this point, used in a small number of research laboratories in the U.S., says CAP Checklists Committee member Christopher M. Lehman, MD, clinical professor of pathology, University of Utah College of Medicine, and medical director of the University of Utah Hospital Laboratory.

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New Color Atlas aids in identifying fungal species

October 2018—CAP Press released in October the Color Atlas of Mycology, by Gordon Love, MD, D(ABMM), and Julie Ribes, MD, PhD. Its 388 pages hold more than 800 tables and images, with identifications verified by DNA sequencing (for images post-2009). Here, in an exchange with CAP TODAY, Dr. Love explains how this atlas stands apart from others in the Color Atlas series and from others on the market.

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Automated molecular platforms: 3 companies on what’s new and next

October 2018—CAP TODAY’s updated guide to the automated molecular platform market begins on page 45. Thirty-four platforms are profiled, with one new one: Hologic’s Panther Fusion. Writer Valerie Neff Newitt talked with three of the 20 companies about what they introduced this year, what’s to come, and more. “This is a dynamic and competitive industry. We are always asked to go faster, and that is what we are trying to do in terms of development,” says Michelle Tabb, PhD, chief scientific officer, DiaSorin Molecular. Others seem to be doing the same.

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AMP case report: NGS in the diagnosis of RAS opathies in histologically uninformative skin biopsy samples

October 2018—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from the University of Washington, Seattle. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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Shorts on Standards—Establishing cutoffs, reference ranges for biofluid biomarkers in Alzheimer’s disease: Reference materials and reference measurement procedures

October 2018—The newly developed National Institute on Aging and Alzheimer’s Association (NIA-AA) research framework uses a biological definition of Alzheimer’s disease.1 This framework has increased focus on biofluid biomarkers, especially because the measurement of cerebrospinal fluid amyloid beta peptide 42 (Aβ42) (or Aβ 42/40 ratio), phosphorylated tau protein (p-tau), and total tau proteins (T-tau) are included in the definition.1 The field of AD biofluid biomarkers is rapidly evolving. For example, CSF neurofilament light (NfL) is associated with AD neurodegeneration and may be a better CSF marker compared with T-tau.

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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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