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Qiagen, Bio*One, Asuragen, Focus Diagnostics, AutoGenomics, Interleukin Genetics, Alticor, Roche, Cancer Genome Atlas Research Network, Johns Hopkins University

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Qiagen, Bio*One Launch Dx Assays JV in Singapore
 
Nine months after saying that they would form a new molecular diagnostics joint venture, called Dx Assays, in Singapore, Qiagen and Bio*One Capital said this week that the new venture has officially launched its operations.
 
The partners announced last December that they would launch the venture, which will focus on developing tests for infectious diseases and oncology applications. It expects to complete initial assay projects by the end of this year and to launch its first products over the next one to two years.
 
“By leveraging the development capabilities of Dx Assays, Qiagen can further strengthen its presence in the rapidly growing Asian market and expand its global portfolio of molecular testing solutions,” said Qiagen CEO Peer Schatz in a statement.
 
He noted that Asia is the firm’s fastest-growing market. The company has seven offices in the region with more than 370 employees.
 
Earlier this year, Qiagen opened a new service solutions center in Singapore to serve the entire Asia-Pacific region. Qiagen said that the new center will help it serve customers in the research, applied testing, pharmaceutical, and molecular diagnostics markets in the entire Asia-Pacific region including Australia.
 

 
Asuragen Licenses RNA Technology to Focus Diagnostics
 
Quest Diagnostics subsidiary Focus Diagnostics has licensed non-exclusive, worldwide rights to Asuragen’s Armored RNA technology for use in molecular diagnostic products, the firms said this week.
 
The Armored RNA technology was jointly developed by Austin, Texas-based Asuragen and reference lab Cenetron Diagnostics for the packaging of RNA or DNA in bacteriophage coat proteins for protection and stabilization. According to the firms, the technology armors the RNA standard against the hazards of nucleases in patient samples.
 
Asuragen will develop and supply reagents for Focus in its QSR-compliant manufacturing facility. Other terms of the agreement were not disclosed.
 
Asuragen is a spin-off of RNAi technologies firm Ambion, which was acquired by Applied Biosystems at the end of 2005 for around $273 million.
 

 
Autogenomics' First-Half '08 Revenues Rise Sharply in Advance of IPO
 
Molecular diagnostics firm AutoGenomics’ first-half 2008 revenues rose nearly eight-fold over the first half of 2007, according to a filing with the US Securities and Exchange Commission last week.
 
The firm said that its revenues for the first six months of 2008 were $2.1 million compared to $271,138 for the first six months of the prior year.
 
AutoGenomics sells the INFINITI molecular diagnostics system, which was cleared by the US Food and Drug Administration for marketing in February 2007. The firm currently offers 26 tests on the system, including research-use-only tests for HPV, respiratory illness, breast and bladder cancer risk, and cystic fibrosis. It also has FDA clearance for a warfarin sensitivity test and for Factor II, Factor V, and Factor II-V panel tests.
 
The Carlsbad, Calif.-based firm filed an amended registration statement for its proposed initial public offering last week, which included updated financial information. AutoGenomics first filed for the IPO at the end of July.
 
The firm has yet to provide an estimated price range for the shares in the offering or a preliminary estimate of net proceeds. However, the filing lists the proposed maximum aggregate offering price at $86.3 million — a figure that did not change in the amended statement.
 
AutoGenomics also disclosed in its amended registration statement that its net loss rose 41 percent to $4.4 million from $6.2 million year over year.
 
Its research and development costs increased 31 percent to $1.7 million from $1.3 million, while its SG&A expenses jumped 57 percent to $3.6 million from $2.3 million.
 
AutoGenomics held cash and cash equivalents of $5.6 million as of June 30.
 

 
Interleukin Genetics, Alticor Expand Genetic Test License Agreement
 
Interleukin Genetics said last week it has expanded an agreement with Alticor division Access Business Group, giving both companies increased access to genetic tests that the two companies have developed together under research programs.
 
Under the agreement, the existing license that ABG holds to Interleukin Genetics’ intellectual property will become non-exclusive, the company said. Interleukin Genetics will gain the right to brand, market, sell, and distribute all genetic tests developed using existing and future intellectual property.
 
ABG also will continue to distribute the Heart Health and General Nutrition genetic tests under the Gensona brand name, and Interleukin Genetics will continue to have exclusive ownership of all of the inventions relating to genetic tests stemming from the two companies’ programs.
 

 
Roche Gets FDA Clearance for Hepatitis B PCR Test
 
Roche has received US Food and Drug Administration clearance for its Cobas TaqMan HBV Test, the firm said last week.
 
The test uses real-time PCR to quantify the amount of hepatitis B virus DNA in a patient’s blood. It may be used by physicians to determine a baseline level of infection and thereafter as an aid in assessing a patient’s response to therapy.
 
According to Roche, it is the first hepatitis B viral load test approved for marketing by the FDA.
 
Roche’s real-time HIV test was cleared by the FDA in May 2007, and the firm has filed for clearance of its quantitative HCV test.
 

 
Genome Studies Uncover New Genes, Pathways Involved in Deadly Cancers
 
A trio of new papers is providing unprecedented insights into the genetics of two of the deadliest forms of cancer — pancreatic cancer and glioblastoma mutiforme, the most common form of brain cancer.
 
Using a combination of copy number analysis, sequencing, methylation, and gene expression studies, two teams of researchers have discovered a slew of new mutations, amplifications, and deletions behind the cancers. In two papers published online last week in Science Express, an international team of researchers examined more than 20,000 genes from 24 pancreatic and 22 brain cancer patients.
 
Meanwhile, a team of researchers collaborating under the auspices of the National Institute of Health’s Cancer Genome Atlas Research Network assessed hundreds of glioblastoma multiforme tumor samples, focusing on about 600 genes of interest. Their work, which uncovered three new brain cancer risk genes and several new pathways of interest, was published online last week in Nature. It marked the first time results from the Cancer Genome Atlas were published.
 
“We can see the mutations in all the genes of each pathway that control growth, replication, and death in the cancer cell,” Baylor College of Medicine Human Genome Sequencing Center researcher David Wheeler, co-author on the Nature paper, said in a statement. “Researchers have never seen the whole landscape like this before, and it’s providing many new insights into strategies to diagnose and treat cancer.”
 
Nearly 40,000 individuals are diagnosed with pancreatic cancer each year in the US and only about five percent survive. Glioblastoma, the most common type of primary brain tumor, is similarly devastating. Most of the roughly 20,000 Americans diagnosed with GBM annually survive just over a year.
 
Last year, a group of researchers led by investigators at Johns Hopkins University characterized the genetic mutations behind 11 breast and 11 colorectal cancer samples. For the latest papers, the team looked at gene sequence, copy number variation, and gene expression in 24 advanced pancreatic adenocarcinomas and 22 GBM samples.
 
After assessing 20,661 genes in pancreatic and brain cancer samples, the researchers pinpointed individual genes and pathways affected in each type of cancer.
 
On average, the pancreatic cancer samples contained 63 somatic alterations. Overall though, the researchers detected 1,562 somatic mutations, along with 198 additional homozygous deletions, and 144 high copy amplifications in the pancreatic cancer samples.
 
“At first glance, these tumors seem very complex,” co-senior author Kenneth Kinzler, an oncology researcher at Johns Hopkins University, said in a teleconference with reporters. But by looking at pathways, he said, “a simpler picture emerges.” Indeed, many of the mutated genes were involved in just a dozen signaling pathways that were altered in between 67 percent and 100 percent of the pancreatic cancer samples.
 
Similarly in their GBM analysis, the researchers identified a bounty of new and previously identified mutations, including alterations in the TP53, RB1, and PI3K pathways.
 
In particular, the team was intrigued by one individual mutation: an amino acid substitution in the active site of isocitrate dehydrogenase 1 protein, coded by a gene called IDH1. Some 12 percent of samples contained the IDH1 mutation, which was especially common in younger brain cancer patients, turning up almost half of GBM patients under 35 years old.
 
Based on these results, Victor Velculescu, an oncology researcher at Johns Hopkins University, told reporters that GBM appears to actually be two diseases, one that involves IDH1 mutations and one that doesn’t. That finding may have prognostic implications, the researchers added, since patients with the IDH1 mutation tended to have longer survival times.
 
Whereas the authors of the Science papers focused on many genes in a few dozen tumors, the Cancer Genome Atlas group — researchers from 18 institutions and organizations led by investigators at BCM, Washington University in St. Louis, and the Broad Institute — presented data on fewer genes in hundreds of samples. They analyzed mutations, CNVs, gene expression, and DNA methylation in 206 GBM multiforme samples and did detailed sequence analysis on 601 genes in 91 GBMs and matched control tissues.
 
Using this approach, they identified three new genes that were frequently mutated in GBM: ERBB2, a gene that’s often altered in breast cancer, the neurofibromatosis gene 1 (NF1), and PIK3R1, a gene involved in a PI3 kinase signaling pathway.
 
They also identified disruptions that affected three distinct pathways — mediating cell division, tumor suppression and apoptosis, and cell growth — in three quarters of the tumors.
 
These findings represent preliminary results for the $100 million Cancer Genome Atlas project, researchers noted. The TCGA team intends to sequence 500 brain cancer samples, eventually covering the entire tumor exome. The project is currently sequencing a second set of genes and this TCGA data will be released onto the group’s website as it is generated.
 
Taken together, the three papers have implications for not only understanding, but also treating and diagnosing cancer. For instance, the Nature study points to methylation changes and “hyper-mutations” that may explain the resistance of some brain tumors to certain chemotherapy drugs.
 
The pathways identified in each study also provide new targets for drug discovery. Rather than trying to identify individual molecular targets, future efforts will likely rely on screening drugs against these commonly affected pathways, Bert Vogelstein, co-lead author on the Science papers and a pharmacology researcher at Johns Hopkins, told reporters.
 
TCGA’s Wheeler also emphasized the importance of looking at pathways rather than genes alone. “If we know what pathways are key to the formation of a tumor, we can design drugs to block those pathways,” he said. “In cancer, key pathways are co-opted to make the cell grow and divide in an uncontrolled way.”
 
In addition, tracking the genes and pathways identified in studies such as these could aid early detection and cancer prevention efforts, Vogelstein emphasized.
 
“This answers the big question about whether the cancer genome project is worthwhile,” BCM Human Genome Sequencing Center Director Richard Gibbs, a co-author on the Cancer Genome Atlas paper, said in a statement. “The results show that it is — definitely.”
 
In a statement issued last week, NIH Director Elias Zerhouni echoed that, saying, “Clearly it is time to move ahead and apply the power of large-scale, genomic research to many other types of cancer.”
 
Andrea Anderson, originally published by GenomeWeb Daily News.

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