IVDT Insight

Celera Corp. and Abbott signed an exclusive distribution agreement to market Celera's CE-marked KIF6 diagnostic test for use on Abbott’s CE-marked m2000 instrument system. The KIF6 genotyping assay detects a genetic marker that may be used in conjunction with clinical evaluation and patient assessment for the identification of individuals at risk for coronary heart disease (CHD), and in patients for whom statin treatment is being considered.

The agreement follows the application by Celera for the CE mark in June 2010, of its real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene. This is the first of Celera’s proprietary cardiovascular genetics products to be CE marked. Under the 4-year agreement, Celera will manufacture the KIF6 test kit that Abbott will distribute in the European Union, other geographic areas that recognize the CE mark, and elsewhere worldwide, excluding the U.S. Financial details of the agreement were not...

September 20th, 2010
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On September 15---the same day as FDA's deadline for public comment on its consideration of actively regulating LDTs---AACC and other groups representing laboratories sent a letter to CDRH head Jeffrey Shuren.
The letter asks FDA to hold "interactive meetings" with laboratory stakeholders to "discuss the framework for the oversight of laboratory developed tests before it moves forward with any proposal in this area," GenomeWeb reports.
The organizations, which clearly have concerns about FDA's interest in LDT regulation, wrote in the letter that they "are united in the desire to engage with FDA in an interactive dialogue to explore and seek solutions that will not disrupt...

September 17th, 2010
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The National Cancer Institute’s Early Detection Research Network recently awarded almost $17 million to Fred Hutchinson Cancer Research Center projects focused on colon cancer biomarker discovery, breast and ovarian cancer biomarker validation, and the ongoing coordination of the EDRN.

Founded in 1999, the EDRN brings together dozens of institutions to help accelerate the translation of biomarker information into clinical applications and to evaluate new ways of detecting cancer in its earliest stages and determine cancer risk.

The five-year awards will support:

The EDRN data management and coordinating center. Biostatistician Ziding Feng, PhD, a member of the Center’s Public Health Sciences Division, was awarded $10 million to lead the EDRN data management and coordinating center, which enhances communication and collaboration among EDRN researchers, coordinates biomarker validation studies, conducts statistical research and disseminates biomarker...

September 16th, 2010
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Roche Diagnostics received 510(k) clearance from FDA for the cobas 8000 modular analyzer series, a Serum Work Area solution designed for diagnostic laboratories with a workload of 3-15 millionclinical chemistry / immunochemistry tests per year.

The cobas 8000 series is the newest member of the Roche cobas modular platform family, which combines clinical chemistry and immunochemistry testing. With a peak throughput of up to 9,800 tests per hour and up to 280 reagents onboard, it offers a variety of features to help high-volume labs deliver reliable test results with greater efficiency and throughput. The system also provides extensive modular flexibility so labs can configure tailored solutions to meet their individual needs.

With the introduction of the cobas 8000 modular analyzer series, Roche now offers a comprehensive portfolio of standardized integrated systems to meet the needs of all types and sizes of clinical laboratories: the stand-alone cobas 4000 analyzer...

September 15th, 2010
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Idaho Technology Inc. launched the new RAZOR Simulant Training Kit (SIM 10) that provides functional training for RAZOR EX and RAZOR operators. The new SIM 10 Kit is formatted exactly like The 10 Target Screen Kit (The 10) and contains assays for yeast and Bacillus globigii (Bg) which are frequently used as powder or anthrax simulants in training exercises. The SIM 10 is available immediately for sale and allows trainees to practice sample collection and preparation, pouch loading, and operating the RAZOR EX or RAZOR BioDetection instrument including data analysis.

First responders receive calls to hundreds of white powder threats each year in the United States. Once a threat is established to be credible and the white powder is determined to be biological, first responders will use the sensitive RAZOR EX instrument with The 10 kit to reliably detect and identify harmful agents in 30 minutes. Since The 10 kit is the most frequently used kit, it is critical for first...

September 14th, 2010
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LabCorp has entered into a definitive agreement under which it will acquire Genzyme Genetics, a business unit of Genzyme Corp., in an all cash transaction valued at $925 million. Net of expected income tax benefits, less acquisition-related expenses, the acquisition has a net cash cost to LabCorp of approximately $795 million.

"Genzyme Genetics is among the premier genetics and oncology laboratories in the United States. It has an excellent clinical reputation, a track record of growth and innovation and outstanding people," said David P. King, Chairman and Chief Executive Officer of LabCorp. "This acquisition will substantially expand our capabilities in reproductive, genetic, hematology-oncology and clinical trials central laboratory testing. The acquisition of Genzyme Genetics provides us with an unprecedented opportunity for revenue growth in our key strategic focus areas of esoteric testing and personalized medicine."

Genzyme Genetics is a...

September 13th, 2010
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 IVD Technology is thrilled to announce that registration for our first-ever Virtual Tradeshow and Conference (VTC) is now open. This event, scheduled for September 28, will include all the networking, information-gathering, speaker presentations, and supplier shopping that characterize live tradeshows---but this event is fully accessible to you right here on your computer screen. No travel logistics or expenses required!

The VTC has been in the works here at our editorial offices for quite some time. It has been a labor of love, and we are perhaps most proud of the speakers we have lined up for you. Our headliner is none other than Alberto Guitierrez, OIVD director at FDA. Our remaining speakers include thought leaders from bioMerieux, Siemens Diagnostics, Gen-Probe, BioSearch, Quidel, and ARUP, as well as the University of Virginia.

For those of you...

September 10th, 2010
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Roche NimbleGen announced that Southern California-based genomic services provider Ambry Genetics has officially become a Certified Service Provider (CSP) for the NimbleGen SeqCap EZ Exome workflow. They will provide target-enrichment services using NimbleGen SeqCap EZ Human Exome coupled with next-generation sequencing services for genetic research. Ambry Genetics has passed a rigorous certification test plan with precise experimental standards to officially join the Roche NimbleGen Certified Service Provider Program. They will process customer gDNA samples for genomic enrichment, using 2.1 million optimized DNA probes from SeqCap EZ Exome to capture all human coding exons, and sequence the enriched samples using short-read, paired-end sequencing.

September 9th, 2010
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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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