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Snippets: Jan 7, 2009

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NIST Calls Personalized Medicine a 'Critical National Need,' Seeks Advice for New Funding Programs
 
The National Institute of Standards and Technology wants genomics, proteomics, and other biomedical researchers to submit ideas about needed advances in personalized medicine, and has asked for white papers detailing these pitches.
 
The NIST call is part of a new program asking for input on a number of subjects it has deemed “areas of critical national need,” including personalized medicine, and the advice will be used to develop new competitions for funding under its Technology Innovation Program.
 
In the area of personalized medicine, NIST said in a listing in the Federal Register, researchers could describe needs for advances in genomics and proteomics that could be used to help doctors develop personalized drug treatments and dosages.
 
NIST is not seeking proposals; it is asking for descriptions of the need and associated societal challenge, why government support is needed, the consequences of inaction, and potential technical solutions.
 
In its call, NIST said personalized medicine, based on genetic, environmental, and metabolic influences on disease, could be a key to addressing the “trial and error” nature of treatment in the current health care system.
 
White papers covering personalized medicine could include descriptions of the challenges of cost-effective tools and techniques for genomics and proteomics research, technologies used in identifying biomarkers, drug and vaccine delivery systems, and better methods of integrating and analyzing biological data when it is combined with environmental and patient history information.
 
Alongside personalized medicine, NIST also sees several other research areas as critical, including civil infrastructure, energy, water supply, manufacturing, nanomaterials and nanotechnology, and sustainable chemistry. It has asked for white papers in those areas as well.
 
More information about the NIST call for white papers addressing areas of critical national need may be found here.
 

 
DxS Extends EGFR Licensing Deal with Genzyme Genetics
 
DxS this week said that it has expanded its licensing deal with Genzyme Genetics covering the epidermal growth factor receptor gene.
 
The license gives Manchester, UK-based DxS rights to develop and sell diagnostic and research products that detect mutations in the EGFR gene for non-small cell lung cancer in the US and Canada. The deal builds on an agreement inked earlier this year that gave DxS similar rights to EGFR worldwide, except for North America and Hong Kong.
 
Genzyme holds the exclusive worldwide diagnostic rights for the use of EGFR gene mutations in testing for NSCLC tumors through a 2005 agreement with Massachusetts General Hospital and the Dana Farber Cancer Institute.
 
DxS currently sells two EGFR products: the EGFR29 research kit and the CE-marked diagnostic test called TheraScreen, which the firm said will be distributed in Europe early this year by Roche Diagnostics.
 
Stephen Little, CEO of DxS, said in a statement that a recent study that compared the cancer drugs gefitinib (Iressa) and carboplatin (Paraplatin) “showed a marked difference in patients' response to treatment according to their genetic status, and we expect there will be an increased demand for EGFR tests to ensure patients receive the most effective treatment.”
 

 
Response Genetics Extends Test Agreement with GSK
 
Response Genetics said last week that it has extended its agreement to provide genetic testing services to GlaxoSmithKline, which will use the services in conjunction with developing cancer treatments.
 
The companies agreed to extend their current master service agreement for two years, and GSK agreed to pay Response Genetics $1.3 million up front.
 
Response Genetics owns a panel of molecular markers for use in its PCR-based genetic tests, including ResponseDX: Lung and ResponseDX: Colon.
 

 
Toronto Clinic to Offer PGXL's Warfarin Test to Canadian Clients
 
The Medcan Clinic in Toronto will offer a genetic test that predicts patient response to the anti-clotting drug warfarin in Canada, under an agreement it signed with PGXL laboratories.
 
Medcan, a preventive health care clinic focused on identifying health risks before symptoms occur, said on Dec. 18 that it has signed an agreement with Louisville, Ky.-based PGXL to offer the warfarin test, which detects variations in the CYP2C9 and VCORC1 genes that are linked to warfarin response.
 
Medcan said that the agreement with PGXL also includes tests for “many other drug therapies,” but did not elaborate.
 
Medcan said that it is the first clinic to offer genetic testing for warfarin response in Canada. 
 
Financial terms of the agreement were not released.
 

 
FDA Approves Roche's Cobas Multiplex Test for HIV, Hepatitis Screening in Donated Blood
 
The US Food and Drug Administration said last week that it has approved Roche’s Cobas TaqScreen MPX Test for screening for the presence of different types of HIV in donated blood plasma and tissue.

The test detects HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C Virus RNA, and hepatitis B Virus DNA in human plasma.

The MPX test is approved for use with plasma specimens from human donors of whole blood and blood components, but not for testing donated source plasma, FDA said. It is also intended for screening tissue specimens obtained while the donor’s heart is still beating.

Roche launched the automated Cobas 201 system and the Cobas TaqScreen MPX Test outside the US in 2006.

"We are pleased to introduce it in the US as we continue to further invest in solutions for this critical industry," said Daniel O'Day, head of Roche Molecular Diagnostics.

“With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients,” said Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

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