IVDT Insight

Thermo Fisher Scientific Inc. announced the launch of the Thermo Scientific Parathyroid Hormone (PTH) Control as the newest product in its immunoassay quality control product portfolio. The company has been showcasing the Thermo Scientific PTH Control at the Thermo Scientific booth during the AACC annual meeting.

This human serum-based liquid QC product is designed to monitor parathyroid hormone tests available on many automated PTH methods including those available from Abbott Diagnostics, Beckman Coulter, Roche Diagnostics, Siemens Healthcare and Tosoh Bioscience.

PTH testing is increasingly used in the clinical laboratory as a method to assess calcium regulation by the body. PTH has a direct impact on calcium absorption (and release) within the human body and has been linked to osteoporosis and other clinical conditions.

The Thermo Scientific PTH Control is offered as a tri-level multi-pack to provide effective coverage of the PTH assay range on automated...

July 28th, 2010
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The National Academy of Clinical Biochemistry (NACB), the professional arm of the American Association for Clinical Chemistry, has acknowledged three posters on which scientists from Beckman Coulter Inc. collaborated with researchers on novel biomarker assays. This year, only 25 of the 820 posters accepted were presented with the NACB distinction.

“The work that these top investigators submitted reflects our commitment to continuous advances with novel markers and applications for our assay systems — and ultimately to improved patient outcomes,” said Kurtis Bray, PhD, director of clinical research in Beckman Coulter’s R&D Product Development Center. “We’re very proud of our scientists’ work and the energy and intelligence they bring to these collaborations.”

The awarded posters include:
   
•    Submitted by Jarolim, et al., a poster outlining a cPAPP-A assay that may,...

July 28th, 2010
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As hospital and clinical laboratories endure increasingly intense pressures to do more with less, they now face another challenge — rising demand for medical tests driven by an aging U.S. population that is expected to swell to more than 70 million in the next 20 years, an increase of more than 80% from today. To help laboratories manage these burgeoning testing volumes, Abbott's ArchitectPlus, the enhanced Architect family of immunochemistry analyzers, being showcased for the first time this week at the American Association for Clinical Chemistry Lab Expo, offers enhanced automation, workstation consolidation, high efficiency and labor savings for laboratories of all sizes.

The new features of ArchitectPlus include more comprehensive and user-friendly software; a smaller size to help reduce space requirements; improvements to streamline operations and reduce interruptions; new video instructions to help with routine maintenance; and an attractive exterior design and...

July 28th, 2010
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Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings (LabCorp) for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus (HCV) infection to peginterferon alpha-based therapy.

LabCorp has developed an in vitro genetic test designed to identify the presence of the IL-28B polymorphism in patients, which studies suggest may be associated with successful response to peginterferon alpha-based therapy, the current standard-of-care in HCV treatment.

“The discovery of a link between the IL-28B polymorphism and response to peginterferon alpha is a scientific finding that may potentially help identify a patient's genetic predisposition for successful response to HCV therapy," said Roger J. Pomerantz, MD, FACP, global franchise lead for Infectious Diseases and senior vice president, Merck Research Laboratories. "Viral hepatitis remains a key focus at Merck, and we...

July 28th, 2010
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As IVD devices become more complex and sensitive, there is a corresponding need for highly specialized sorbents that are custom built and can be incorporated into the packaging of the device. These sorbents will ensure the device’s reliability and integrity remain intact and preserved from production to distribution and until opened for use. Typically an IVD’s most vulnerable components are the substrates or reservoirs containing chemical reagents or biologically-active proteins that react, sometimes electrochemically, with the sample to produce a product that can be measured optically or photometrically.

The key to maintaining IVD device integrity is the use of intelligent sorbents that ensure a specific packaging environment outcome is achieved. Many manufacturers make the critical mistake of choosing an off-the-shelf product. “The reality is, there is no such thing as a one-size-fits-all solution,” says Adrian Possumato, Global Director of...

July 28th, 2010
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Hycor Biomedical Inc., a manufacturer and marketer of in vitro diagnostic products for the global allergy, autoimmune and urinalysis markets used in clinical laboratories throughout the world, announced the launch of a new branding initiative with the launch of a Hycor You Tube Channel as part of its continuing transformation to a broad diagnostics company. This and other initiatives have been debuting at the American Association for Clinical Chemistry Clinical Lab Expo.

“We continue to build on the historical core strengths of high quality, cost effective lab based solutions that Hycor was built upon as we lead the company forward to an exciting future,” said Dick Aderman, CEO of Hycor.  “Since gaining control of our destiny by becoming an independent organization just a few months ago we are creating a revitalized organization with our partners at Linden that is more energized, collaborative, and better focused to develop new products and new...

July 28th, 2010
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As actress Lindsay Lohan now knows, there are a variety of ways to test a person’s bodily fluids for alcohol consumption, both before and after an arrest for driving under the influence and to monitor adherence during rehabilitation. During her recent probation for DUI, Lohan found herself in a special ankle bracelet that uses Breathalyzer technology to sample the sweat on the skin every half hour to determine if an individual violates probation by drinking alcohol. In Lohan’s case, the device was triggered several times, prompting the judge to consider these violations when sentencing her to 90 days in jail.

In most cases where individuals are suspected of driving under the influence, breath analyzers are used to determine blood alcohol concentration, but according to Dr. Amitava Dasgupta, Director of Clinical Chemistry, Toxicology and Point-of-Care Services at Memorial-Hermann Hospital, Texas Medical Center in Houston, not all breath analyzers are created equal...

July 28th, 2010
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Axela Inc., an innovator in systems for multiplex protein biomarker testing in clinical research and diagnostics, has acquired Xceed Molecular, developer of the award-winning Ziplex System for gene-expression analysis, the Breast Cancer Prognostic Assay, and Colon Cancer Xpress chip. The new Axela was introduced at the 2010 American Association of Clinical Chemistry annual meeting and Clinical Lab Expo. The expanded company offers clinical researchers a comprehensive suite of products for enhanced analysis of proteins, pathogens, DNA, and RNA to speed validation and clinical application of biomarkers.

Axela will now be headquartered at Xceed's former facility in Toronto. Rocky Ganske has been named chief executive officer, with overall responsibility for the company's financial and manufacturing operations; David Deems is Axela's president, overseeing sales, marketing, and business development. The two will work together on defining and implementing the company's overall...

July 27th, 2010
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Thermo Fisher Scientific Inc. announced the launch of the Thermo Scientific Sera-Mag SpeedBeads Blocked-Streptavidin Magnetic Particles for automated immunoassay, immunoprecipitation, DNA/RNA purification and protein purification applications. These uniform, colloidally-stable, monodispersed, nominal 1 µm particles use a non-surfactant, non-protein surface-blocking approach to provide very low non-specific binding and high binding capacity for biotinylated target molecules. The company is showcasing the Thermo Scientific Sera-Mag SpeedBeads Blocked-Streptavidin Magnetic Particles at the Thermo Scientific booth during the 2010 AACC annual meeting.

"The low non-specific binding characteristics of our blocked streptavidin magnetic particles significantly reduce lipids, proteins and other undesirable entities from binding to the particle and interfering with assay precision and specificity. These particles also greatly reduce the need for protein-based blockers that...

July 27th, 2010
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Seegene announced SeePrep and SeeCycler, new clinical instrumentation optimized for Seegene's multiplex real-time detection tests. SeePrep performs automated magnetic bead nucleic acid extraction, and SeeCycler is an automated detection system for processing samples in real-time. With the addition of these equipment Seegene is now able to provide a complete molecular diagnostic workflow optimized for its multiplex tests, including nucleic acid extraction, amplification, real-time PCR testing and data analysis. The complete system is on display at the 2010 Annual Meeting and Clinical Lab Expo of the American Association for Clinical Chemistry (AACC).

"Seegene multiplex real-time PCR products are defining a new era of powerful assays that can rapidly and accurately diagnose a pathogenic infection and genetic mutation. These tests arm medical professionals with the information they need for better and more cost-effective patient care," said Jong-Yoon Chun, Chief...

July 27th, 2010
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