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NSH webinar: Wednesday, Dec.17, 1 p.m. EST
Human epidermal growth factor receptor 2 gene (ERBB2) commonly referred to as HER2 is amplified in 18 percent to 20 percent of breast cancers. HER2 overexpression in invasive breast cancer is associated with a higher rate of recurrence and mortality. HER2 status is also predictive for several therapies. The optimal assay performance parameters to assess HER2 status, either by immunohistochemistry, in situ hybridization or fluorescent in situ hybridization, remains controversial. As testing accuracy and method validation remain a troubling issue, join Joelle Weaver, MS,HTL(ASCP)QIHC to discuss what validation and quality assurance strategies your laboratory can use. Register today!
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What happens when results data from clinical trials goes missing?
The Wall Street Journal
Over the past few years, several studies have indicated that drug makers and academic researchers fail to report results of clinical trials to a U.S. government website. Only about 15,000 of the approximately 178,000 registered trials in the United State's main database,, currently include summaries of results, according to officials at the National Institutes of Health. That works out to a paltry 8 percent. It is a cause for concern because the lack of results means that potentially important information about medicines is unknown.
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5 questions for clinical research sites
For a new drug to approved, it needs to be studied rigorously at clinical research sites to ensure the drug's safety and efficacy in patients. So what exactly is happening at clinical research sites? We asked Christine Pierre, the founder and president of The Society for Clinical Research Sites and the CEO of RxTrials Inc.
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Mechanical cues reprogram normal cell lines into stem-like cells
Scientists at the University at Buffalo and other institutions have turned cells normally used as model cells, known as immortalized cells, into stem or, as they call it, "stem-like" cells, using nothing more than mechanical stress. They have done it without employing the potentially hazardous techniques previously used to obtain similar results.
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Blood, simpler
The New Yorker
Theranos is a Silicon Valley company working to upend the lucrative business of blood testing. Blood analysis is integral to medicine. When your physician wants to check some aspect of your health, such as your cholesterol or glucose levels, or look for indications of kidney or liver problems, a blood test is often required. This typically involves a long needle and several blood-filled vials, which are sent to a lab for analysis. Altogether, diagnostic lab testing, including testing done by the two dominant lab companies, Quest and Laboratory Corporation of America, generates $75 billion dollars a year in revenue.
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Engineers at Michigan Technological University create pocket-sized, multi-test medical lab-on-a chip using computer-aided design technology
Dark Daily
For almost two decades, developers have touted the potential of lab-on-a-chip technology to play a greater role in clinical laboratory testing. Now the latest twist on this technology story is that computer engineers are using the power of computer-aided design to develop innovative lab-on-a-chip designs.
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Helping scientists, helping the world
Lab Manager
In its seventh official year as a nonprofit organization, Seeding Labs has assisted labs in 23 countries around the world with shipments of donated lab equipment. The organization also received a $3 million investment from the U.S. Agency for International Development this year which has allowed them to expand their staff and infrastructure to help even more scientists. Building partnerships so that scientists in developing countries have access to training and collaboration opportunities is also a big part of the group's mission.
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Geography may limit access to cancer clinical trials
Fox News
Where advanced cancer patients live affects the likelihood that they can enroll in a treatment clinical trial, a new study found. Fewer than 10 percent of U.S. cancer patients participate in clinical trials, the authors note. "Clinical trials are the basis for the vast majority of advances in cancer care, so, the only way to move the field forward is for patients to participate in clinical trials," said lead author Dr. Matthew D. Galsky of the Icahn School of Medicine at Mount Sinai in New York.
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In Florida, UnitedHealthcare's new clinical lab benefit management program triggers objections from physicians and excludes most medical labs
Dark Daily
Medical laboratory testing is at the center of a contest of wills in Florida. On one side is a health insurer that wants to require physicians to obtain pre-notification or preauthorization for a list of clinical laboratory tests. On the other side are the physicians who question the clinical basis for these requirements and the time and resources required to comply with the health insurer's program.
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Missed last week's issue? See which articles your colleagues read most.

    NSH webinar: Relationships Between ISO, CLIA, and CLSI for Histotechnology (NSH)
Breast cancer vaccine shows promise in slowing progress (TIME)
Scientists discover why bowel cancer sometimes outsmarts treatment (Cancer Research UK)
At the University of Michigan, research study indicates how composition of gut microbiome may serve as complementary, noninvasive screening tool for colon cancer (Dark Daily)
Turning skin cells into brain cells: A Huntington's disease research breakthrough? (HDBuzz)

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