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Labline is a FREE Weekly MLO Update

December 29, 2011

In This Issue:

arrowVirtual patients test medical devices safely

arrowAACC announces 2012 Webinars

arrowMolecular markers can predict spread of cancer, guide treatment

arrowDNA study of mast cell leukemia may lead to improved therapies

arrowPathology Visions conference draws digital professionals from 17 countries

arrowFDA issues draft guidance for use of nucleic acid tests on blood samples

arrowRegulatory enzyme overexpression may slow progression of Huntington’s disease

arrowHot Clips: Regulations/Compliance

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Virtual patients test medical devices safely

Researchers have long been challenged by the fact that new medical procedures and devices often cannot be safely tested on real people. This has also made it difficult for developers of those devices and procedures to gain FDA approval for them. Increasingly, the challenge is being met by the use of “virtual patients”—computerized models that utilize software, graphics, and medical data to simulate the human body and find answers to otherwise unanswerable questions. Problems involving the amount of radiation exposure that is safe during a CT scan, for example, are being addressed. Questions regarding the safe amount of radiation for pregnant women are studied as well, as is the issue of how much radiation can be safely and effectively used in medical procedures for obese patients, who generally need higher doses because body fat disperses radiation waves.

One center of research in this area is Rensselaer Institute in Troy, New York, where Dr. X. George Xu’s team of nuclear engineers use virtual patients to better understand the action of radiation in the human body. Another is the Center for Devices and Radiological Health, which is part of the FDA. Scientists there are using a “virtual family” of adults and children to learn more about how to implant medical devices in children. The anatomy of children’s hearts is different from that of adults, for example, which has implications for the mechanics of defibrillator implantation in the young.

The FDA is also using the virtual patient technology to look into improved diagnostic techniques, as in catheterization to locate blockages. Down the road, it also might be used for training doctors and medical students in surgical techniques. The clinical applications of virtual patients are only beginning to be realized. Read more about it in a Wall Street Journal article.

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AACC announces 2012 Webinars

The American Association for Clinical Chemistry (AACC) has announced its 2012 schedule of 12 webinars and has facilitated registration through its website. The subject of the monthly webinar series is “High-Value Tests for High-Impact Diseases.” January, February, and March webinars will be dedicated to cardiac disease; April, May, and June webinars will be devoted to diabetes and glucose control; July, August, and September webinars will address kidney disease and AKI (acute kidney injury); and October, November, and December webinars will focus on thyroid disease. Each webinar will cover best practices in testing for its disease.

AACC also announced two more upcoming webinars of interest to laboratorians. “An Update of Clinical Applications for Vitamin D Assays,” on January 26, will provide information on the latest testing platforms used to assay vitamin D in clinical human samples and on how to manage the analytical challenges involved in performing these assays. “Body Fluid Testing in the Clinical Laboratory,” on February 8, will address questions about body fluid analysis, focusing on non-standard sources of body fluid and the clinical utility and clinical impact of these often-challenging requests. Learn more about the high-value tests series and the January and February programs, including how the webinars work, cost, and registration information.

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Molecular markers can predict spread of cancer, guide treatment

Molecular markers found in cancer cells that have spread from a primary tumor to a limited number of distant sites can help physicians predict which patients with metastatic cancer will benefit from aggressive, targeted radiation therapy. In a study published online in PloS One, University of Chicago researchers show that if cells from metastatic tumors have high levels of a particular type of microRNA—a tool cells use to silence certain genes—not even aggressive treatment of those tumors would help. But if the cells have lower levels of that biological marker, then focused local treatment could be effective, even curative.

"This finding means we can have a pretty good sense in advance of which patients we can help. Patients unlikely to benefit from focused, local therapy can move on to systemic treatment," said study author Ralph Weichselbaum, MD, professor and chair of radiation and cellular oncology and Director of the Ludwig Center for Metastasis Research at the University of Chicago. Weichselbaum and his colleagues have proposed that there is an intermediate state between localized cancer and cancer that had spread extensively. In 2004, they began a small clinical trial to test that theory. Patients with stage IV cancer with one to five distant metastases and no tumors bigger than 10 centimeters in diameter were enrolled. The results showed that precisely targeted radiation therapy could eradicate all evidence of disease in about 20 percent of those patients. A follow-up study, published this past October, found that 18 percent of patients in that initial trial had seen no cancer progression and 27 percent developed no new tumor sites.

The tumors most likely to spread had high levels of the nucleic acid microRNA-200c. Researchers showed that microRNA-200c reduced the activity of other genes that acted to prevent the spread of cancer. Read the study.

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DNA study of mast cell leukemia may lead to improved therapies

Cancer researchers at New York-based Cold Spring Harbor Laboratory have carried out the first comprehensive study of the changes seen in the DNA of a patient with mast cell leukemia (MCL), an extremely aggressive subtype of acute myeloid leukemia (AML) with a very poor prognosis. Their genomic survey has helped identify two previously unknown mutations that could directly influence patient response to currently available therapeutic drugs. The details uncovered by the study not only suggest a diagnostic improvement and an alternative treatment strategy for MCL, but could lead to new diagnostic and therapeutic approaches for other cancers, including lymphoma.

In the study, which appears in the journal Leukemia, researchers used two approaches to identify genetic changes in an MCL patient who succumbed to the disease about three months after diagnosis. In one approach, they used array comparative genetic hybridization (aCGH) to identify copy number variations—genomic alterations that result in an abnormal number of copies of one or more sections of DNA—in the leukemic mast cells. In a second approach, they sequenced the majority of the “exome”—the “exons” which are the DNA sequences that encode for protein. This enabled them to identify mutations that result in a difference of a single nucleotide, or chemical rung in the DNA ladder, between the patient’s normal and tumor cells.

Learn more and view a graphic showing how a single nucleotide change may prolong the life of a mast cell and eventually lead to MCL.


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Pathology Visions conference draws digital professionals from 17 countries

Digital pathology professionals gathered in San Diego last month for the 7th annual Pathology Visions Conference. The Digital Pathology Association (DPA) meeting featured more than 50 presenters and 42 educational sessions.

“We had the highest number of attendees in the history of our conference, and we are very proud of the role the Pathology Visions Conference plays in the education of those in the digital pathology profession,” says Dirk Soenksen, President of the Digital Pathology Association and Chair of the Pathology Visions Program Committee. Participants came from 30 states, 17 countries, and 174 organizations to learn from one another and gain a greater understanding of the newest applications of digital pathology.

Among the highlights were two presentations, the keynote address and regulatory panel discussion. Dr. Mahul B. Amin’s keynote presentation was entitled “Personalized Medicine: Empowering Light Microscopy and the Pathologist.” Dr. Amin, Chairman and Professor in the Department of Pathology and Laboratory Medicine at Cedars-Sinai Medical Center, reviewed the role of the pathologist in contemporary healthcare and discussed the contributions, strengths, and limitations of traditional microscopy.

The regulatory panel discussion, “Navigating Digital Pathology’s Path to Patients,” was led by Dr. Stephen Hewitt, NCI and a member of the 2009 FDA Hematology and Pathology Devices Advisory Panel on Digital Pathology. Panelists included Tremel Faison, MS, RAC, SCT (ASCP), representing the FDA Office of In Vitro Diagnostic Device Evaluation and Safety; Walter Henricks, MD, Cleveland Clinic, representing the CAP Laboratory Accreditation Program; and Debra Sydnor, representing the CMS Division of Laboratory Services (overseeing CLIA). Learn more about the conference and the Digital Pathology Association.

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FDA issues draft guidance for use of nucleic acid tests on blood samples

The Food and Drug Administration has released a document entitled “Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus.” As a draft document, it is provided so that stakeholders can make comments. Electronic comments may be submitted at through January 27, 2012.

The Guidance document begins, “We, FDA, are providing you, blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes; with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). We are also providing you with recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling.” It contains sections on rationale for donor screening using HBV NAT; donor requalification; donor screening using HBV NAT; management of donors and units based on hepatitis B test results; requalification methods for donors on the basis of HBV NAT and HBV serologic test results on the follow-up sample; information for whole blood and blood components intended for transfusion; blood components intended for further manufacture; reactive units and product disposition; test implementation; labeling; and procedures for requalification of donors. You can download the document as a PDF file.

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Regulatory enzyme overexpression may slow progression of Huntington’s disease

Treatment that increases brain levels of an important regulatory enzyme may slow the loss of brain cells that characterizes Huntington's disease (HD) and other neurodegenerative disorders. In a report receiving advance online publication in Nature Medicine, a Massachusetts General Hospital (MGH)-based research team from the MassGeneral Institute for Neurodegenerative Disease (MGH-MIND) reports that increased expression of Sirt1, one of a family of enzymes called sirtuins, in the brain of a mouse model of HD protected against neurodegeneration. Researchers also identified a potential mechanism for this protective effect.

In experiments with a mouse model of HD, the researchers first showed that knocking out Sirt1 expression in the brain accelerated the appearance of HD-like pathology – such as aggregates of mutant huntingtin and increased cell damage in key areas of the brain. In contrast, a strain of HD mice in which Sirt1 was overexpressed lived longer, with significantly less neurodegeneration and huntingtin aggregation, than did HD mice in which Sirt1 expression was unaltered. Cellular experiments showed that Sirt1 overexpression directly protects neurons from the toxic effect of mutant huntingtin.

The MGH-MIND team also discovered a new target for Sirt1 activity in TORC1, a brain protein known to regulate several important neuronal genes, and found that the presence of mutant huntingtin interferes with the interaction between Sirt1 and TORC1, reducing expression of the regulated genes. View an abstract of the article along with graphics.

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HOT CLIPS: Regulations/Compliance - Top Picks

Click on the highlighted links below to discover the top MLO archival properties concerning regulations/compliance, a topic that is now at the forefront of healthcare discussions.

  1. NAT in blood screening around the world
  2. Collaborative medicine: weaving the microbiology laboratory into clinical practices
  3. D-Light: Vitamin D and good health
  4. Hepatitis trends

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