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October 27, 2011

In This Issue:

Scientists say XMRV poses no risk to blood supply

National Genetics Organization changes name to better reflect expansion of field

FDA warns pharmacies to stop pushing needle-free flu vaccine

AACC launches new Certificate Program 'Improving Outcomes through Point of Care Testing'

FDA clears Siemens fully automated Vitamin D Total Assay for ADVIA Centaur Systems

Biomarker detects graft-versus-host-disease in cancer patients after bone marrow transplant

Early adopter of INFORM HER2 Dual ISH assay optimistic about impact on patient care, hospital bottom line

Hot Clips: Lab Outreach Tips

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.

Scientists say XMRV poses no risk to blood supply

In August, the AABB, the umbrella group made up of centers and groups that collect most of the nation’s blood supply, recommended that until the scientific questions were worked out, people with CFS should be discouraged from giving blood. The Red Cross, which collects about 50% of the nation’s blood, bars patients with a medical history of CFS from donating. But just last month, a federal Blood XMRV Scientific Research Working Group reported that nine labs testing for XMRV or evidence of XMRV infection in the blood of CFS patients and healthy donors either didn’t find the retrovirus or couldn’t reproduce their findings. The authors of the 2009 paper that found a possible link between XMRV and CFS have partially retracted their findings, citing contamination in some of the blood samples.

The results of the new study, conducted with Abbott Diagnostics, Gen-Probe Inc., and Yale University School of Medicine, were presented on Saturday at the annual scientific meeting of the AABB in San Diego.

Visit the Wall Street Journal for the article >>>

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National Genetics Organization changes name to better reflect expansion of field

The American College of Medical Genetics Board of Directors has voted to add the word "Genomics" to its name, thereby changing the name to "American College of Medical Genetics and Genomics" officially to be in effect at the 2012 ACMG Annual Clinical Genetics meeting in March 2012.

The ACMG acronym will remain the same. The ACMG was founded in 1991 in recognition of the importance of the genetic approach to diagnosis, management, and prevention of disease, maintaining health, and improving the quality of life for all people.

Since the sequencing of the human genome, we have entered an era that is changing the very fabric of biological research and medical practice. Medical geneticists have long embraced a genomic approach in healthcare, initially in the analysis of chromosomes and more recently in the application of cytogenomic microarrays and whole genome sequencing. The addition of Genomics to the name recognizes the increasingly central role of medical genomics and its importance alongside genetics in fulfilling the mission of the ACMG.

Visit ACMG.net for more information >>>

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FDA warns pharmacies to stop pushing needle-free flu vaccine

For this year’s flu season, hundreds of pharmacies are for the first time offering painless, needle-free shots to ward off the disease. But there’s one big problem: They may not work. The FDA has warned doctors, nurses and pharmacists “not to use injector devices to administer influenza vaccines.” The agency’s alert notes it has not approved any “injector devices” for use with the flu vaccine.

“The FDA has no data to support the safety or effectiveness of other vaccines delivered by jet injector,” the alert reads. So patients who already received the shot may need to go back and get a jab in the arm with a needle after all.

While the needle-free devices have been approved for use with some drugs, FDA spokeswoman Shelley Burgess said vaccines are out of the question. “Vaccines are labeled with specific instructions for how those vaccines should be administered,” Burgess said. “At this time, there are no vaccines for the prevention of influenza disease that are approved by the FDA for administration by jet injector.”

Visit ABC News for the article >>>

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AACC launches new Certificate Program 'Improving Outcomes through Point of Care Testing'

On October 1, 2011, American Association for Clinical Chemistry (AACC) launched its ninth certificate program, Improving Outcomes through Point of Care Testing. The use of point of care testing is rapidly expanding, and with this new growth comes new challenges and new opportunities for advancement. This certificate program provides participants with the opportunity to learn about the many circumstances under which point of care is being done and the cutting edge technology that is shaping where point of care technology may go next. The program is composed of eight courses which can be completed online in 1 to 2 hours each.

For more information about the certificate program or AACC >>>

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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

FDA clears Siemens fully automated Vitamin D Total Assay for ADVIA Centaur Systems

The FDA has cleared the Siemens Healthcare Diagnostics Vitamin D Total assay for use on the ADVIA Centaur/XP Immunoassay Systems, enabling laboratories to consolidate vitamin D testing with routine testing on a single, fully automated immunoassay platform. The assay, which is traceable to LC/MS/MS (liquid chromatography-mass spectrometry), measures the total level of 25-hydroxyvitamin D [25(OH)D] in serum and plasma to aid in the assessment of vitamin D sufficiency. Measurement of [25(OH)D], the most widely used indicator of vitamin D status, ensures accurate evaluation of patients for deficiency, sufficiency, or toxicity.

As people limit their sun exposure due to the risk of skin cancer, vitamin D deficiency rates have been increasing globally. In the U.S., approximately 77 percent of adults are either insufficient or deficient in vitamin D, according to the National Health and Nutrition Examination Survey (NHANES) III from 2001 to 2004.

To ensure accuracy, the Siemens’ ADVIA Centaur Vitamin D Total assay measures a patient’s total 25(OH) vitamin D level – ~100% of 25 (OH) vitamin D2 and D3, metabolites of the two major forms of vitamin D. Because circulating 25(OH)D can arise from hydroxylation of either vitamin D2 or D3, measurement of total 25(OH)D (both D2 and D3) is essential for accurate assessment of vitamin D status.

For more information about the ADVIA Centaur Vitamin D Total assay, visit: www.siemens.com/vitamindtotal >>>

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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

Biomarker detects graft-versus-host-disease in cancer patients after bone marrow transplant

A University of Michigan Health System-led team of researchers has found a biomarker they believe can help rapidly identify one of the most serious complications in patients with leukemia, lymphoma and other blood disorders who have received a transplant of new, blood-forming cells. Known as a hematopoietic stem cell transplant, these patients receive bone marrow or peripheral blood stem cells from a matched donor who is either a family member or an unrelated volunteer.

The most common fatal complication of this type of transplant is graft-versus-host disease (GVHD), where the newly transplanted immune system of the donor attacks the patient's skin and internal organs. Up to 30 percent of recipients develop GVHD in their gastrointestinal tract, which is the organ most resistant to treatment.

Without invasive tests such as biopsies, however, GVHD can be difficult to distinguish from other causes of gastrointestinal distress, such as infection or side effects from medication.

Visit Science Daily for the article >>>

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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

Early adopter of INFORM HER2 Dual ISH assay optimistic about impact on patient care, hospital bottom line

University Medical Center in Tucson (UMC) is validating the VENTANA INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH) on the BenchMark XT automated slide staining instrument to help determine HER2 gene status in breast cancer patients in an effort to change the paradigm for targeted treatment therapies.

The assay, developed by Ventana Medical Systems, Inc., a member of the Roche group, is the first fully automated assay approved by the FDA for determination of HER2 gene status in breast cancer as an aid in the assessment of patients considered for treatment with Herceptin (trastuzumab).

For breast cancer patients, waiting days or even weeks for accurate test results can feel like an eternity. The VENTANA HER2 Dual ISH assay provides complete, walk-away automation on the VENTANA BenchMark XT instrument, transforming the diagnostic process and dramatically reducing the turnaround time for accurate results. Today, many labs rely on fluorescent in situ hybridization (FISH) assays to test for HER2 gene amplification. These assays must be run manually by skilled technologists, making them extremely labor-intensive and time consuming.

Visit here for the release >>>

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