IVDT Insight

CLC bio, AROS Applied Biotechnology, F. Hoffmann-La Roche, and Aarhus University Hospital - the Institute of Pathology and the Research Unit for Molecular Medicine, announced a collaboration to develop a solution for large scale use of formalin fixed, paraffin embedded (FFPE) tissue in molecular analyses.

The project goal is to develop a complete platform for selecting appropriate FFPE samples, choosing the optimal sequencing technology, and subsequently assembling and analyzing the high-throughput sequencing data. The main application areas will be molecular diagnostics research and re-analysis of pre-clinical trials where drugs have failed despite relatively high rates of positive responses. The project is budgeted to $5 million, half of which will be funded by the Danish National Advanced Technology Foundation.

Using the proposed platform, researchers will have access to more samples than can be collected in traditional fresh tissue biobanks. Equally important,...

September 8th, 2010
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Beckman Coulter Inc. announced that Scott Garrett has resigned as Chairman, President, and CEO, effective September 6, 2010. Garrett will continue as a full-time non-executive employee of the company through January 15, 2011, focusing his attention on aiding the Board of Directors during this transition.

The Board appointed J. Robert Hurley interim President and CEO, effective September 6, 2010, and will initiate a search for a successor. Hurley, who has served as the company's senior vice president, human resources, and chairman of Beckman Coulter Japan, joined the company in 2005, and most recently led the integration of the Olympus acquisition. Prior to joining Beckman Coulter, he was an executive with Baxter International, leading its operations in Asia for more than 8 years.

Glenn S. Schafer, lead independent director, was appointed by the Board to the post of non-executive Chairman.

Garrett said, "Over the past eight years, five of them as CEO, I've...

September 7th, 2010
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CSI Laboratories announced the lease of a new 65,000 square foot facility in Alpharetta, GA, located north of Atlanta. CSI Laboratories is committing $15 million to its strategic expansion project, and this newly leased space will house its next generation laboratory, with clinical operations beginning in mid-2011. Fueled by strong demand for its personalized testing services, CSI Laboratories will utilize this new facility to achieve greater than a three-fold increase in laboratory capacity, medical offices, and administrative support.

Leading up to this expansion, CSI Laboratories has grown its medical team and executive leadership by recruiting top talent from around the country. Laboratory directors, Lawrence Hertzberg, M.D., Steve Kargas, MD, PhD, and Theresa Brown, PhD, each left Genzyme Genetics to join CSI during the past three years. Keith Sharkey, VP of Sales and Marketing, came to the organization after serving in sales management roles with US LABS and GenPath/...

September 6th, 2010
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Abbott received approval from FDA to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient's blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results.

The Abbott RealTime HBV assay, based on real-time PCR technology, is now available for laboratories that use the Abbott m2000 automated instrument system for molecular diagnostic testing. The test offers sensitive measurement (quantitation) of HBV in human plasma or serum from individuals chronically infected with HBV.

The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. Assay results must be interpreted within the context of all relevant clinical and lab findings. Use of the assay to...

September 3rd, 2010
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At the Engineering in Medicine and Biology Conference in Buenos Aires, Argentina, the Interuniversity Microelectronics Centre (IMEC) and its project partners announced the launch of the European Seventh Framework Project, MIRACLE. The MIRACLE project aims at developing an operational lab-on-a-chip for the isolation and detection of circulating and disseminated tumor cells (CTCs and DTCs) in blood. The new lab-on-a- chip is an essential step toward faster and cost-efficient diagnosis of cancer.

In a preceding joint project by some of the partners (MASCOT FP6-027652), individual microfluidic modules for cell isolation, cell counting, DNA amplification, and detection have been developed. Based on this expertise and strengthened by additional partners, the development of a fully automated, lab-on-a-chip platform to isolate, count, and genotype CTCs is envisaged within the framework of the MIRACLE project. For genotyping, genetic material (i.e., mRNA) will be extracted from the...

September 2nd, 2010
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Pacific Biosciences announced that on August 27, 2010, it was named as a defendant in a complaint filed by Helicos Biosciences Corp. in the U.S. District Court for the District of Delaware. In the complaint, Helicos alleges that Pacific Biosciences is infringing two patents allegedly licensed by Helicos and two patents allegedly owned by Helicos, by making, using, and selling its SMRT technology for single molecule sequencing of DNA and teaching customers how to use the SMRT technology and PacBio RS sequencing platform. While Pacific Biosciences cannot guarantee any particular outcome in this case, it believes that Helicos’ claims are without merit and will vigorously defend against the claims asserted in the complaint.

The four patents asserted by Helicos are U.S. Patent Nos. 7,645,596 and 7,037,687 (each titled “Method of Determining the Nucleotide Sequence of Oligonucleotides and DNA Molecules”), 7,169,560 (titled “Short Cycle Methods for...

September 1st, 2010
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Myriad Genetics Inc. announced that its Board of Directors has authorized the repurchase of an additional $100 million of the company's outstanding common stock, following the completion of its previously authorized stock repurchase program initiated in May 2010.

As a result of its initial stock repurchase program, Myriad returned $100 million to its shareholders through the repurchase of 5.7 million shares of common stock, at an average price of $17.54 per share. The shares that the company repurchased represents 5.8% of its total issued and outstanding shares.

Under the new authorization, the company plans to repurchase an additional $100 million of shares of its common stock from time-to-time in open market purchases or privately negotiated purchases as determined by the company's management. Myriad expects to complete the new share repurchase on or before June 30, 2011.

Based on Myriad's closing share price on August 30, 2010, the new $100 million stock...

August 31st, 2010
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NEC Corp. (NEC) and SomaLogic Inc. announced that they have signed an agreement to explore aptamer-related businesses in the life sciences and healthcare markets. In addition, NEC announced that it has made an equity investment in SomaLogic in support of a long-term strategic relationship between the two companies.

The agreement establishes a framework for the two companies to develop and implement applications within NEC’s cloud-based services platform to enhance SomaLogic’s products for life sciences research and diagnostics. Customers will include pharmaceutical companies, research laboratories, and practicing physicians, with the eventual goal of expanding into personal healthcare services.

August 30th, 2010
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 Yesterday FDA issued a medical device alert regarding the use of fingersticks and other POC blood-testing devices. The message was clear: Do not reuse these devices. Doing so promotes the transmission of blood-borne infection.
CDC and FDA have seen a progressive increase in reports of blood-borne infections in the past decade. Hepatitis B was the most-transmitted of these infections. The agencies point to the shared use of fingersticks and other similar devices as being a leading cause of this problem. The infections are occurring in a variety of healthcare settings, the agencies say; however, a "significant increase" in Hepatitis B outbreaks are related to the shared use of multiuse fingerstick devices and POC blood-testing devices in long-term-care and...

August 27th, 2010
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Sysmex announced a three-year sole source microscopic urinalysis contract agreement with group purchasing organization Novation. Novation is the leading health care supply contracting company for more than 25,000 members of VHA Inc. and the University HealthSystem Consortium, two national health care alliances, and 5,500 members of Provista LLC, representing 28,000 sites. Members have immediate purchasing/leasing access to Sysmex UF-Series automated urine particle analyzers, reagents, controls, and service. Training and technical support for members will be provided through Sysmex America's U.S. headquarters in Mundelein, IL. The contract was awarded on technical merit and pricing. In addition to its sole source contract, Novation awarded Sysmex America a related dual source contract with Siemens' ADVIA Urinalysis WorkCell.

Novation's contract offering also includes Sysmex Peak Performance Program, a comprehensive set of systems and resources that support a clinical...

August 26th, 2010
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