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LABline is a FREE Weekly MLO Update

October 20, 2011

In This Issue:

arrowAbbott to separate into two leading companies in diversified medical products and research-based pharmaceuticals

arrowNew survey reveals Americans want better access to and understanding of blood test results

arrowMicroPhage partners with Cardinal Health on funding, marketing first one-day susceptibility test

arrowAACC announces two new webinars for December 2011

arrowCustom, optimized antibody panels now available from Beckman Coulter Flow Cytometry

arrowFDA approves Zelboraf (vemurafenib) and companion diagnostic for BRAF mutation-positive metastatic melanoma

arrowTwo cancer studies find bacterial clue in colon

arrowHot Clips: Lab Outreach Tips


Programmable Temperature controlled FISH Processing System
The StatSpin Thermobrite® automates the denaturation and hybridization steps in slide-based fluorescent in situ hybridization (F)ISH assays and reduces hands-on time while ensuring precision and +/- 1º accuracy.

Visit www.statspin.com.


Abbott to separate into two leading companies in diversified medical products and research-based pharmaceuticals

Abbott announced that it plans to separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals. The diversified medical products company will consist of Abbott's existing diversified medical products portfolio, including its branded generic pharmaceutical, devices, diagnostic and nutritional businesses, and will retain the Abbott name. The research-based pharmaceutical company will include Abbott's current portfolio of proprietary pharmaceuticals and biologics and will be named later. Both companies will be global leaders in their respective industries.

Abbott's proprietary pharmaceutical business has delivered market-leading performance with a sustainable mix of products and built a strong pipeline of proprietary medicines through internal discovery, in-licensing and collaboration efforts.

The research-based pharmaceutical company has nearly $18 billion in annual revenue today and will have a sustainable portfolio of market-leading brands, including Humira, Lupron, Synagis, Kaletra, Creon and Synthroid. An attractive pipeline of innovative R&D assets—in important specialty therapeutic areas such as Hepatitis C, immunology, chronic kidney disease, women's health, oncology and neuroscience—will help drive future growth. The company will have an extensive, broad-based pipeline of new products and technologies as well as opportunities for significant margin expansion.

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New survey reveals Americans want better access to and understanding of blood test results

Ortho Clinical Diagnostics (OCD), in partnership with the National Association of Chronic Disease Directors (NACDD), unveiled new consumer survey results and a report revealing the state of blood test health literacy in the United States with strategies to support much-needed patient education and empowerment. The first step: ensuring patient access to and understanding of blood test results, a critical component to maintaining health and wellness. The campaign kicks off during National Health Literacy Month, an awareness effort founded in 1999 to promote the importance of understandable health information.

The survey found that although nearly 90 percent of people would prefer to discuss blood test results during a doctor's visit, only about 40 percent have discussed their results in person, primarily because the results were either mailed or emailed to the patient or the patient never received the results. In addition, some respondents reported that providers told them to assume everything was okay if the doctor did not notify them about the results.

Based on these findings, the "Know Your Numbers" campaign was developed to help patients realize the importance of blood test results in maintaining their health, and encourage them to take a more active role in obtaining and engaging with their healthcare providers to understand blood test results. Key to achieving the goals of the campaign is ensuring that laboratories can get results directly to patients and their healthcare providers, currently a limiting factor in 39 states.

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MicroPhage partners with Cardinal Health on funding, marketing first one-day susceptibility test

MicroPhage, Inc., developers of diagnostic products for bacterial identification and antibiotic susceptibility and resistance testing, announced it has reached an agreement with Cardinal Health granting exclusive rights to market the KeyPath MRSA/MSSA Blood Culture Test product line in North America. Under this agreement, Cardinal Health will gain the exclusive distribution rights to the recently 510(k)-cleared KeyPath MRSA/MSSA Blood Culture Test – BT and other products in development for testing blood culture specimens for Staphylococcus aureus in the U.S., Canada and U.S. territories.

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Document Control, Incident Tracking, Training Records, Lean Six Sigma, management made easy

Manage your regulatory compliance system utilizing our Paradigm 3 software. Our software is easy to use and can be completely managed by the end user with no consulting or IT involvement. Targeted action items are sent to appropriate personnel ensuring assigned tasks are completed on time. Learn more now.
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AACC announces two new webinars for December 2011

The American Association for Clinical Chemistry (AACC) announces two new webinars for December 2011: A New Era in Down Syndrome Screening on December 7; and Optimizing Clinical Laboratory Test Utilization on December 14. The webinars will commence at 2:00pm Eastern and run for 90 and 60 minutes respectively.

AACC’s expert panel for the webinar, Mark I. Evans, MD, Director, Comprehensive Genetics (New York, NY) and Professor of Obstetrics & Gynecology, Mt. Sinai School of Medicine, and Nathalie Lepage, PhD, FCACB, Chief, Division of Biochemistry and Head of the Biochemical Genetics Laboratory, Children's Hospital of Eastern Ontario, Ottawa, Canada, will discuss the latest medical thinking on the role of screening in the diagnosis of Down Syndrome.

There are a variety of reasons for test overutilization, including misunderstanding the diagnostic value of the test itself, patient pressure and test bundling. An AACC expert will provide information on how to identify areas in need of management and strategies to optimize test utilization. Michael Astion, MD, PhD, Division Chief, Laboratory Medicine, Seattle Children's Hospital and Professor of Laboratory Medicine, University of Washington, in Seattle, WA, and a leading authority on test utilization, will discuss the root causes of overutilization and how the laboratory can identify them, where labs should intervene for effective results, strategies that work to reduce overutilization, and why insurance companies are expanding their oversight of unnecessary testing and reducing payments.

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Proven excellence
The 3500 Series Genetic Analyzers are designed to support the demanding performance needs of validated and regulated environments while retaining the unsurpassed application versatility that researchers expect. Detect up to 6 fluorescent dyes for higher levels of multiplexing in fragment analysis applications, as well as perform Sanger Sequencing, the gold standard for confirming genetic variation. www.appliedbiosystems.com

Custom, optimized antibody panels now available from Beckman Coulter Flow Cytometry

Custom Design Services (CDS) from Beckman Coulter, Inc. provides researchers with single and multicolor custom-tailored conjugate configurations as well as purified antibodies. Beckman Coulter scientists, having extensive experience in the design and optimization of multicolor reagent panels, work with a wide variety of proprietary or customer-supplied human and non-human antibodies and use a comprehensive array of fluorochromes to create tests for an expansive range of targets.

Two-to 10-color panels can be composed using fluorochromes to meet specific experimental requirements. Proprietary tandem dye technology provides optimal coupling efficiency and enhances signal-to-noise ratio, so that dyes can be used to detect low-density antigens without the loss of sensitivity. Antibodies may be lyophilized or supplied in a specified buffer solution.

Krome Orange, a novel violet-excited organic dye from Beckman Coulter, expands the range of available choices and dye sensitivity limits for violet lasers and facilitates the development of high-quality, multicolor panels. The panels are packaged in exclusive black vials to protect against photobleaching.

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CD4 Monitoring Solutions from BD
Get proven simplicity with the BD FACSCanto™ II flow cytometer, BD FACS™ 7-color setup beads, and BD Multitest™ reagent, the industry’s only 6-color TBNK reagent. The solution delivers consistent, reliable results and enumerates NK cells by analyzing the expression of CD16 and CD56 simultaneously in the same conjugation. Standardized analysis is delivered by BD FACSCanto™ clinical software. For a free lab assessment or to learn more, visit: http://www.bdbiosciences.com/go/cd4

FDA approves Zelboraf (vemurafenib) and companion diagnostic for BRAF mutation-positive metastatic melanoma

Roche announced that the U.S. Food and Drug Administration (FDA) approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test. The FDA also approved the cobas 4800 BRAF V600 Mutation Test, a diagnostic test developed by Roche to identify patients eligible for treatment. Zelboraf is the first and only FDA-approved personalized medicine shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma, demonstrating the benefits of Roche’s personalized healthcare approach. It is designed to target and inhibit some mutated forms of the BRAF protein found in about half of all cases of melanoma, the deadliest and most aggressive form of skin cancer. Zelboraf will be available in the United States within two weeks of approval.

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LifeSign Status Flu A&B Test
All new rapid Influenza A&B test. With the unique and innovative “flip” cassette design, the Status Flu A&B test brings to your facility an accurate and easy to use test. www.lifesignmed.com

Two cancer studies find bacterial clue in colon

For years, Dr. Robert A. Holt, a genomics researcher at the British Columbia Cancer Agency, wrestled with a question about colon cancer. Might it be caused, or pushed along, by a bacterial infection? Cancers of the liver, stomach and cervix have all been linked to microbes, he knew. And if there is one place in the body with a lot of microbes, it is the colon — microbial cells outnumber human cells there by a ratio of at least nine to one.

The new tools of genomic analysis offered an opportunity to look for a connection. What Dr. Holt and another group of researchers, working independently, have found is completely unexpected and puzzling. One particular species of bacterium never particularly prevalent in the colon seems to have a disturbing affinity for colon cancers. The two research groups discovered the link by analyzing genetic material in tumor samples. They then subtracted human genes from the mix. What remained were microbe genes.

An analysis of these microbial genes showed that a type of bacterium, Fusobacterium, was abundant in the tumors although it normally is not among the more prominent species in the gut. Not only were the bacteria lurking around the cancer cells, but Dr. Holt found in subsequent experiments that they actually were burrowing into tumor cells — “which is kind of creepy,” he said. An ability to invade cells, he said, is often what distinguishes a disease-causing microbe from one that is harmless. Of course, that doesn’t prove that Fusobacteria are causing tumors. They might just find the cancer cells a good place to live.

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HOT CLIPS: Lab Outreach - Top Picks

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Click on the highlighted links below to discover last week’s top MLO archival properties concerning lab outreach, a topic that is now at the forefront of healthcare discussions.

  1. Outreach strategy: differentiate or die
  2. Laboratory rep: “rules of the road”
  3. An objective approach to selecting a reference laboratory
  4. Competition and cooperation: Labs in a complex industry

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