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June 2014

Data spark new directions in cervical cancer

June 2014—When Mark Stoler, MD, stood up to speak at the 30th annual Clinical Virology Symposium on April 29, his topic was timely. Dr. Stoler was presenting three-year followup data from the ATHENA trial, in which a primary human papillomavirus screening algorithm based on the Roche Cobas HPV assay was compared with traditional cytology and a hybrid cotesting algorithm for their ability to prevent cervical cancer.

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New analyzers, connectivity, tests, and software features

June 2014—Cleared in April by the FDA is Nova’s newest—the Stat Profile Prime, which features Zero maintenance cartridges and MicroSensor technology. The Zero maintenance cartridge technology consists of individual cartridges for biosensors, calibrators, and liquid QC. The design optimizes the life of each cartridge, improves analyzer uptime, and eliminates the waste, downtime, and higher costs associated with older systems, says Rick Rollins, Nova marketing specialist. Stat Profile Prime analyzers deliver a 10-test profile—pH, PCO2 , PO2 , Na, K, iCa, Cl, Hct, glucose, and lactate—in 60 seconds.

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Put it on the Board, 6/14

June 2014—For trainees, information ‘gaps are closing’: With the dismissal of residents from training programs having led to well-known tragedies, the most recent in pathology just a year ago, attention is being paid to the importance of ensuring residents’ well-being and properly handling remediation, probation, and dismissal.

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A question of capital: Will lab purchasing take a U-turn?

June 2014—If they made disaster movies about the laboratory industry, you could cue the voice talent right now, because all the plot elements seem ready at hand. In a world where an economy haltingly recovers from the blows of recession, a series of double-digit reimbursement cuts for laboratory services looms. New financial accounting standards lurk in the background, threatening to roil traditional equipment rental arrangements. A mammoth national health insurance program rolls out, generating fears of one set of dictates to rule them all.

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Cancer biomarker use varies widely, needs a ‘broader view’

June 2014—Despite an explosion of research into cancer biomarkers and professional guidelines that urge testing for certain genetic mutations that help detect disease, anticipate its course, or predict response to treatment, many cancer centers are out of sync with oncology testing recommendations. Payment policies, regulatory oversight, clinician preferences, and varying access to testing technology are among the factors that contribute to discrepancies in cancer care.

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Protecting Access to Medicare Act
CAP on rule to implement law: ‘We will be there’

June 2014—The CAP’s leaders say they will keep pushing for favorable pathology payment policies as federal regulators implement new legislation that could lead to steep cuts in Medicare rates. Six weeks before the May 5–7 CAP Policy Meeting in Washington, DC, Congress enacted the Protecting Access to Medicare Act of 2014. The bill, signed into law April 1, stopped cuts to physician services under the flawed Medicare sustainable growth rate formula used to calculate Medicare pay.

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NGS to detect oncogenes—sizing panels, reporting results

June 2014—Scientific wonders always abound at the Advances in Genome Biology and Technology conference, and this year’s meeting in February was no exception. Attendees had their first opportunity at a scientific meeting to learn about the newly announced Illumina HiSeq X Ten, a combination of 10 HiSeq X systems, which, Illumina says, can sequence 16 whole human genomes per three-day run at a read depth of 30× and a cost of $1,000 per genome. At the other end of the scale, attendees saw the unveiling of Oxford Nanopore’s MinION, a sequencer the size of a pack of chewing gum.

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Anatomic Pathology Selected Abstracts, 6/14

June 2014—Utility of triple antibody cocktail intraurothelial neoplasm-3 and AMACR in urothelial CIS and reactive urothelial atypia: Urothelial carcinoma in situ (CIS) is a prognostically and therapeutically significant lesion with considerable morphologic overlap with reactive conditions, especially in the setting of prior therapy. Various markers, including CK20, CD44s, and p53, have been used as an adjunct in making this distinction.

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Clinical Pathology Selected Abstracts, 6/14

June 2014—How a single patient influenced HIV research: 15-year followup: The hope of a cure for human immunodeficiency virus infection is raised by recent reports of people in whom viral replication spontaneously reduced despite the absence of antiretroviral treatment (ART). A “Berlin patient” described in 1999 was immediately treated with ART and hydroxyurea after an acute HIV infection but chose to discontinue treatment.

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Using molecular techniques to confirm donor-derived post-transplant lymphoproliferative disorder

June 2014—Post-transplantation lymphoprolif-erative disorders (PTLD) encompass a spectrum of neoplasms, ranging from benign hyperplasia to non-Hodgkin lymphoma and Hodgkin lymphoma. Epstein-Barr virus is postulated to play a key role in the pathogenesis of PTLD in patients who were previously EBV negative. This is a case report of a 52-year-old female, status post unrelated bone marrow transplant for myelofibrosis, who developed primary central nervous system diffuse large B-cell lymphoma, post-transplantation.

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microRNAs entice as diagnostic key to multiple diseases

June 2014—In research and development of diagnostics based on the small, non-coding RNAs known as microRNA, the potential clinical applications in cancer were the first to be explored and have hogged the spotlight. But the more light that is shed on micro­RNAs’ mysteries, the more promise microRNA shows as a diagnostic and therapeutic tool in an array of diseases beyond cancer.

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Newsbytes, 6/14

June 2014—Making the most of big data no easy task: A trillion base pairs of sequence here, a trillion there. Pretty soon, you’re talking about a lot of information—and it all needs to be managed. That’s the dilemma facing Mayo Clinic and other health care organizations leading the personalized medicine revolution that relies on compiling and analyzing patients’ genetic code to better diagnose, predict, and treat disease.

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Q & A Column, 6/14

June 2014—Treatment with rasburicase seems to affect the uric acid analysis. Drawing the specimen in a pre-chilled lithium heparin tube appears to eliminate the falsely low uric acid results we see. Are there current studies regarding uric acid test analysis on patients receiving rasburicase?

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