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Sloning Biotechnology, BioMérieux, Ipsogen, Warnex, NHGRI, Rosetta Genomics, MRSA Dx, Applera, ABI, Celera, Abbott

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Sloning and BioMérieux Team to Find Gene Variants for Dx Development
 
Sloning Biotechnology and BioMérieux will collaborate on a feasibility study to develop gene variants for an enzyme BioMérieux can use in its in vitro diagnostics development programs, Sloning said this week.
 
Sloning, based in Munich, Germany, said it will use its Slonomics gene-synthesis technology to offer BioMérieux “a gene library with a full set of ratio-controlled mutants.”
 
BioMérieux plans to use the results of the study to identify an enzyme “with significantly enhanced characteristics” for molecular diagnostics applications.
 
Financial terms of the agreement were not released.
 

 
Ipsogen Grants Warnex Exclusive License to JAK2 Leukemia Dx in Canada
 
Ipsogen said this week it has granted Warnex exclusive rights to market its JAK2 leukemia diagnostic test in Canada.
 
The test is based on variations in the JAK2 gene, for which Ipsogen holds intellectual property rights. It detects certain mutations in the gene linked to myeloproliferative disorders, including myelogenous leukemia, polycythemia vera, essential thrombocythemia, and idiopathic myelofibrosis. 
 
Ipsogen said it offers the test as both a product and via a licensing program.
 
Financial terms of the agreement were not released.
 

 
NHGRI Sets Aside $27.5M for Population-Based GWA Studies for 'Complex Diseases'
 
The National Human Genome Research Institute plans to hand out a total of $27.5 million in grants for large-scale genome-wide association studies aimed at identifying genetic variants that relate to undisclosed ”complex diseases.”
 
The allocation will support between three and five studies over four years that aim to create population-based data to speed the process of understanding how certain genes are related to certain complex diseases.
 
According to an NHGRI RFA, the research will use information from population-based cohort studies or clinical trials with “detailed existing information on demographics, health characteristics, environmental exposures, and disease risk factors and traits.” 
 
The NHGRI said it expects the studies to attempt to “determine the population-based profile, or ‘epidemiologic architecture,’” of variants such as those in racial and ethnic subgroups in the US.
 
The studies also would identify modifiers of gene-trait associations, such as lifestyle or medicinal factors, and would identify clues that link causal variants to phenotypes.
 
The RFA would support assaying selected SNPs and other genetic variants with strong evidence for a possible causal association with a disease or trait; statistical analysis of the prevalence and associations of these variants on a population basis; provision of calculated descriptive and association data in readily interpretable form to a central database; cataloguing and disseminating the characteristics of participating population studies to be used for such investigations; and inviting collaborations with outside investigators for further functional or translational research. 
 
It would also provide limited funding for whole-genome amplification of “scarce, high priority” DNA samples, such as those from rare or severe disease cases or persons with extreme phenotypes; for researchers to isolate DNA from uniquely valuable stored samples; and for those who transform cryopreserved cells in highest priority participants.
 
The RFA said that the NHGRI looks to the “power and potential of large-scale GWA studies” to find genetic variants related to disease and stressed that this potential has been amply demonstrated with recent successes in macular degeneration, inflammatory bowel disease, diabetes, prostate cancer, breast cancer, and coronary disease.
 
Letters of intent for the grants are due on Oct. 19, and applications must be received by Nov. 19.
 
Additional information can be found here.
 

 
Readying to Deploy Dx Products, Rosetta Genomics' CEO Moves to US
 
Rosetta Genomics said last week that its CEO, Amir Avniel, has moved his office from the company's headquarters in Rehovot, Israel, to New York as part of a plan to expand its US operations.
 
The company said the move will "facilitate the expected launch of Rosetta Genomics' first products, growth through partnerships and collaborations, as well as corporate operations in the US."
 
"As we move closer to the planned launch of our first diagnostic products in 2008 and to ensure the growth and expansion of our technologies, it is critical to have our senior executives based in the US," said Yoav Chelouche, Rosetta Genomics' chairman of the board of directors.
 
Michael French, president of the company’s US subsidiary, Rosetta Genomics Inc., has departed the company. Avniel will assume French's responsibilities, the company said.
 

 
MRSA Dx Sales Help Drive 37 Percent Jump in Cepheid's Q2 Revenues
 
Cepheid announced last week that its second-quarter revenues increased 37 percent as R&D spending rose 28 percent and net loss declined around 26 percent.
 
Total receipts for the three months ended June 30 increased to $27.2 million from $19.8 million year over year. This included $23.6 million of total product sales, which increased 25 percent from $18.9 million for the second quarter of 2006.
 
The company attributed the increase in product sales to a 165 percent increase in clinical product sales and a 43 percent increase in industrial sales, offset slightly by a 26 percent decrease in biothreat sales, compared to the year-ago period.
 
"The increase in clinical product sales during the second quarter reflects growing market traction for on-demand molecular diagnostics, particularly with the adoption of the Xpert [methicillin-resistant Staphylococcus aureus] test,” Cepheid CEO John Bishop said in a statement.
 
The company said the decrease in its biothreat business was due to a planned reduction in the price of Cepheid’s Anthrax cartridges to the United States Postal Service that is linked to a five-year agreement that the company is currently negotiating with USPS.
 
Instrument sales rose around 133 percent to $9.4 million; reagent and disposable sales decreased 5 percent to $14.2 million; contract revenues rose 180 percent to $1.9 million; and government and government-sponsored research revenue soared more than five-fold to $1.7 million.
 
R&D spending rose to $7.4 million from $5.8 million year over year.
 
Net loss fell to $5.2 million from $7 million in the year-ago period.
 
Cepheid said it had around $7.2 million in cash and cash equivalents, and $38.3 million in marketable securities at the end of the second quarter.
 
The company expects total revenue for the full year to be between $117 million and $123 million.
 

 
Applera Mulls Spinning Out ABI and Celera into Two Independent Firms
 
Applera announced last week that it has hired investment bank Morgan Stanley to advise the company as it considers restructuring its Applied Biosystems and Celera groups, which are currently traded as tracking stocks under the parent firm.
 
Applera said it will explore alternatives to its current structure, and will look into “creating two independent publicly traded companies in place of the two tracking stocks.”
 
ABI markets instruments, consumables, software, and services for the research and applied markets. Celera, originally formed to sequence the human genome, has evolved into a molecular diagnostics firm.
 
"We regularly review Applera's corporate structure, and in view of Celera's continued strong financial progress, we believe the time is now right to explore alternatives to our tracking stock structure, including the possibility of creating two independent publicly traded companies in place of the two tracking stocks," said Applera CEO, President, and Chairman Tony White.
 
"While the tracking stock structure has facilitated the interests of both Celera and Applied Biosystems,” White added, “the evolution of our businesses makes it timely to explore the potential benefits of these businesses going their separate ways."
 
Applera’s board of directors also has nearly doubled its share-repurchase authorization for ABI’s stock to $1.2 billion, which represents around 20 percent of the company’s outstanding common stock.
 
Through that repurchase, Applera expects to buy $600 million shares either through a tender offer or an accelerated share repurchase, the company said.
 
The balance of that deal will come “from open market purchases or privately negotiated transactions” over the next year to year and a half, the company said.
 
"The substantial increase and acceleration of the Applied Biosystems share repurchase program reflects our confidence in its business outlook and our belief that its shares continue to be undervalued in the market,” added White.
 
White also said ABI’s “strong cash position” makes the share repurchase program “an effective way to return value to shareholders.” 
 

 
Abbott Gains FDA Approval for 'Enhancements' to HIV-1 Test
 
Abbott said last week it has received supplemental pre-market approval from the US Food and Drug Administration for improvements to its RealTime HIV-1 viral load test, which runs on its m2000 RT PCR platform.
 
The FDA initially cleared the test in May.
 
Abbott said the supplemental approval will allow it to market “a number of enhancements” for the test, including a feature that will allow labs to use smaller amounts of blood plasma.
 
Abbott markets the m2000 system and its line of tests internationally through an agreement with Celera.
 
The test detects and quantitates common HIV-1 strains, "as well as all known genetic variations of the virus, including group O, group N, and non-B subtypes," the company said.
 
Abbott said the ability to use smaller samples to identify HIV-1 will be useful because of the challenges of obtaining blood samples from critically ill patients.
 
The company said the enhanced system can process up to 96 specimens in a batch and 192 specimens in one laboratory shift, which it said is the "highest throughput available" for an HIV-1 test using RT-PCR technology.

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