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July 2013

Q & A, 7/13

July 2013—Can you clarify the difference between the terms “optimization,” “validation,” and “verification” as used in immunohistochemistry? These three terms relate to the processes that the laboratory must undertake before new diagnostic, prognostic, or predictive immunohistochemistry markers are used for clinical and/or pathologic decisionmaking.

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Put it On the Board, 7/13

July 2013—The FDA approved Abbott’s hepatitis C virus genotyping test for use in the United States. The RealTime HCV Genotype II test differentiates genotypes 1, 1a, 1b, 2, 3, 4, and 5 and is run on the automated m2000 platform. Gavin Cloherty, PhD, Abbott Molecular’s director of scientific affairs, told CAP TODAY the test has a 99.5 percent accuracy relative to sequencing and a greater than 99 percent discrimination of HCV genotype 1 subtype 1a versus 1b. Time to result for 22 samples and two controls, he said, is 5.25 hours, with 30 minutes hands-on time.

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AMP v. Myriad Genetics: the end of the beginning

July 2013—The most remarkable fact about the June 13 decision of the Supreme Court in Association for Molecular Pathology v. Myriad Genetics, ___ U.S. ___ (2013), is that both sides are proclaiming victory. The physicians and geneticists who challenged efforts to enforce patents on the BRCA1 and BRCA2 genes are elated that the Court has squarely held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”

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Anatomic Pathology Selected Abstracts, 7/13

July 2013—Intraoperative pathologic examination in the era of molecular testing for differentiated thyroid cancer: Diagnostic thyroidectomy is typically indicated for indeterminate thyroid cytology results. Traditionally, intraoperative pathologic examination (IOPE) helped guide the extent of initial surgery. Preoperative molecular testing of fine-needle aspiration cytology has emerged as another diagnostic adjunct, is highly specific for thyroid cancer, and can lead to appropriate initial total thyroidectomy.

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Clinical Pathology Selected Abstracts, 7/13

July 2013—Risk factors for first venous thromboembolism around pregnancy: Venous thromboembolism is a serious maternal complication occurring at a rate of one to two per 1,000 maternities during pregnancy and the puerperium. Venous thromboembolism (VTE) is a leading cause of maternal mortality in developed countries and an important source of morbidity in the form of post-thrombotic syndrome.

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