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Cepheid, Gen-Probe, Xceed Molecular, USDA, NIH-GenBank, DNAVision, Ipsogen, Wellcome Trust, Takeda, Novartis, Daiichi Sankyo, SAE Consortium

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Cepheid Gets OK to Market Molecular Dxs in Canada, Mexico
 
Cepheid said this week that regulatory authorities in Canada and Mexico have cleared for marketing certain of the firm’s molecular diagnostic tests for hospital-acquired infections.
 
The Sunnyvale, Calif.-based firm said that Health Canada had issued a medical device license for its Xpert GBS, which detects Group B Streptococcus, and Xpert EV for detection of enterovirus-associated meningitis. It said that Fisher Scientific, a division of Thermo Fisher Scientific, will exclusively distribute the tests in Canada.
 
Cepheid received marketing clearance earlier this year from Health Canada for its Xpert MRSA test for detection of methicillin-resistant Staphylococcus aureus.
 
All of the tests run on the firm’s GeneXpert System, an automated molecular diagnostic instrument system that combines on-board sample preparation with PCR amplification.
 
Cepheid also said that regulatory authorities in Mexico had registered the firm’s GeneXpert System, as well as the MRSA, GBS, and EV tests. Those products will be exclusively distributed in Mexico by IL Diagnostics.
 

 
Gen-Probe Licenses Molecular Dx Technology from Xceed; Offers to Buy Innogenetics for $334M
 
Xceed Molecular announced this week that Gen-Probe has non-exclusively licensed the firm’s Flow-Thru Chip technology.
 
The Wellesley, Mass.-based company said that Gen-Probe expects to use the technology to develop next-generation multiplexed molecular diagnostics.
 
Under terms of the deal, Gen-Probe will pay up-front licensing and milestone fees to Xceed for non-exclusive access to the chip technology in certain fields. Gen-Probe also has the right to receive co-exclusive rights with Xceed in certain undisclosed sub-fields. San Diego-based Gen-Probe also will make royalty payments to Xceed based on sales and will purchase Xceed’s custom TipChips, Ziplex automated gene expression system, and other Xceed products.
 
“There are many promising applications for moderate-density arrays in clinical diagnostics and other applications, and we believe that Xceed’s technologies in combination with our own technologies will facilitate our entry into these expanding markets,” Dan kacian, executive vice president and chief scientist for Gen-Probe, said in a statement.
 
Separately, Gen-Probe has made a bid to buy the Belgian molecular diagnostics company Innogenetics for €215 million ($334 million) in cash, or €6.10 a share, besting an April offer of €5.75 a share from drug maker Solvay.
 
The offer is roughly 4.3 times Innogenetics’ diagnostic revenues of approximately €51 million in 2007.
 
San Diego-based Gen-Probe said that Innogenetics would give it a strong manufacturing, marketing, and distribution presence in Europe, and that it would expand the company’s product range.
 
According to Gen-Probe, the combined company would offer nucleic acid and immunoassay tests for bacterial and viral infections, genetic conditions, neurological disorders, and transplant compatibility. The products Gen-Probe would gain include ones that are “generating revenue today or that we believe could be commercialized in the future," Gen-Probe CEO Hank Nordhoff said in a statement.
 
Innogenetics’ main offerings include CE-marked genotyping assays for infectious diseases, including hepatitis C and B, and human papillomavirus, and it holds a PCR license from Roche and a license for Luminex’s xMAP multiplex technology. The HPV test was cleared by European regulatory authorities earlier this week.
 
Ghent-based Innogenetics also is restructuring and is closing its therapeutics subsidiary, GENimmune, to focus its efforts on the diagnostics market.
 
Gen-Probe said it has filed a draft takeover prospectus with Belgian financial authorities, and it hopes to close the deal in the fourth quarter of 2008.
 
The acquisition is subject to several conditions, including regulatory clearance and acceptance of at least 90 percent of Innogenetics’ outstanding shares, or 75 percent if the company introduces a new “one share, one vote” principle, Gen-Probe said.
 
Solvay has not yet made public a decision about whether it will try to match the bid.
 

 
USDA Releasing Genomic Data from 150 Bird Flu Viruses
 
The United States Department of Agriculture has released the complete genetic sequences of 150 different avian influenza viruses and will make the information available through the National Institutes of Health’s GenBank.
 
The USDA said last week that the sequencing data is part of the federal government’s Initiative on avian Influenza, and that this information will be combined with studies that compare the viruses’ ability to infect poultry such as chickens, turkeys, and domestic ducks.
 
This virus research that generated this data was conducted by the USDA’s Agricultural Research Service’s Southeast Poultry Research Laboratory (SEPRL), by the University of Georgia, the Ohio State University, the University of Delaware, and the University of Alaska-Fairbanks.
 
"The project's ultimate goal is to sequence 900 avian influenza viruses from the SEPRL repository," David Suarez, a researcher with SEPRL, said in a statement. "These include avian influenza viruses collected from both poultry and wild bird species in the United States and around the world.
 
"This sequence information, deciphered by our large team, will help researchers better understand virus biology and improve diagnostic tests for avian influenza viruses," Suarez added.
 
Sequencing services for the project were conducted by the Houston-based company SeqWright.
 

 
DNAVision to Offer Ipsogen's MapQuant Breast Cancer Test
 
DNAVision said Sunday that it will offer Ipsogen’s new MapQuant Dx Genomic Grade test through its central lab services in Europe.
 
The MapQuant Dx is a molecular diagnostic, gene expression-based test that measures tumor grade, risk of metastasis, and chemotherapy response, among breast cancer patients. Ipsogen launched the test last week.
 
The MapQuant runs on Affymetrix’s GeneChip platform and was developed under an agreement between Affy and Marseille, France-based Ipsogen in August 2007.
 

 
Wellcome Trust, Takeda, Novartis, Daiichi Sankyo Join SAE Consortium
 
Novartis, Takeda, The Wellcome Trust, and Daiichi Sankyo have all joined an organized effort to develop and identify genetic markers that could be used to predict which patients may be at risk for experiencing dangerous adverse reactions to specific drugs.
 
The International Serious Adverse Events Consortium, a non-profit group that initially launched a year ago, is a partnership between drug companies, the US Food and Drug Administration, and research institutes.
 
As Pharmacogenomics Reporter sister publication GenomeWeb Daily News reported at that time, a number of drug companies each invested $500,000 initially to begin the effort, which was kicked off by SAEC Chairman and CEO Arthur Holden. 
 
These new pharmaceutical members also will provide funding and scientific support, according to the SAEC. In addition, The Wellcome Trust also will provide financial backing and assistance in executing genomic studies.
 
If the SAEC can identify and validate DNA variants that are associated with serious adverse events, the group “hopes to reduce the significant patient and economic costs caused by drug-related SAEs,” the group said in a statement.
 
Holden said in a statement that the “involvement of companies from around the world, like our new members, is a critically important development to help us meet our research goals.”
 
The SAEC’s initial programs are focused on discovering markers associated with drug-related liver toxicity and with Stevens Johnson Syndrome, which is a rare but serious skin condition that has been associated with more than 200 different types of medications.
 
“The work of the SAEC promises to be important in moving forward the study of the molecular basis of drug induced serious adverse events, and in providing leadership in this area,” said Alan Schafer, who is The Wellcome Trust’s head of molecular and physiologics sciences.
 
In addition to a number of pharmaceutical companies, other contributing groups include Newcastle University, the academic consortium DILIGEN, EUDRAGENE, and Columbia University, which is hosting the SAEC’s data analysis and coordinating center.

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