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Qiagen, Epigenomics, Roche, 454 Life Sciences, Ciphergen, Nanogen

Qiagen, Epigenomics Expand Alliance to Include Molecular Dx
Qiagen this week announced that it has licensed exclusive worldwide rights to Epigenomics' sample-handling technologies for applied testing and in vitro diagnostics as part of an expansion of an earlier alliance.
The companies inked an OEM agreement two years ago that gave Qiagen exclusive rights to Epigenomics' bisulfite DNA treatment technology and Methylight assay technology for research uses.
Under the new agreement, Qiagen will pay Epigenomics an up-front fee, milestone payments, and royalties, Qiagen said. Financial terms of the deal were not disclosed.
Epigenomics will retain the rights to its sample technologies in its own or partnered development projects and for commercializing diagnostics through a non-exclusive back-license from Qiagen.
Qiagen said the expansion follows the launch of the EpiTect Bisulfite kit, which uses Epigenomics' DNA-methylation technology and is for research use only. Based on the results of that program, Qiagen said the companies now plan to use DNA methylation to develop and sell a complete and validated IVD pre-analytical sample technology portfolio.
Qiagen CEO Peer Schatz said the companies expect DNA methylation technology to play an important role in the molecular diagnostics market, particularly in areas such as cancer screening.
Schatz said Qiagen's epigentic testing portfolio now includes "sample technologies such as DNA sample collection, stabilization, purification, and bisulfite conversion to assay technologies such as PCR- and sequencing-based methods for DNA methylation analysis."

Roche Completes Acquisition of 454
Roche has closed its acquisition of CuraGen subsidiary 454 Life Sciences in a cash and stock deal valued at as much as $155 million, 454 and CuraGen said this week.
454's 167 employees will remain at the company's facilities in Branford, Conn., and will operate under the Roche Diagnostics division.
454 President Christopher McLeod said the deal brings his company "added resources to the research and development and manufacturing activities ... both of which are expected to expand as we see increasing demand for our sequencing products and services."
Roche Diagnostics has been the sole worldwide distributor for 454's Genome Sequencer systems and reagents since 2005.
CuraGen CEO Frank Armstrong said the divestiture brings the company a significant infusion of capital, and the firm now has around three years worth of operating cash to fund continued development of its cancer therapeutics programs.

Ciphergen Raises Doubt About Ability to Stay Afloat
Ciphergen said in a recent US Securities and Exchange Commission filing that its current cash balances “may not be sufficient to fund planned expenditures."
According to the company, "This raises substantial doubt about our ability to continue as a going concern."
The disclosure came a few days after Ciphergen said in an earlier SEC filing that first-quarter revenue ran dry as R&D spending dropped 36 percent and losses widened 11 percent.
In that filing, CEO Gail Page said the company would change its name to Vermillion. Page said the company believes the name Vermillion "befits the substantial transformation" in the company as it moves to becoming a diagnostics company with tests on the market.
Page said shareholders will vote on the name change at the company's annual meeting in late June.
Total receipts for the three months ended March 31 dwindled to $21,000 from $7.1 million year over year. The massive drop was due to the sale of the company's proteomics tools business to Bio-Rad (see BioCommerce Week 8/16/2006).
Ciphergen had said previously that its revenue would evaporate after the sale of the proteomics business, and that it did not expect new income until it gets one of its diagnostics to the market.
The company has three tests in validation and in clinical studies that it is trying to commercialize: an ovarian triage test, a test for a hematologic disease that causes abnormal clotting, and a test for peripheral arterial disease.
Ciphergen expects to submit the ovarian cancer test to the US Food and Drug Administration for clearance in 2007, and plans to continue pursuing collaborations to identify and in-license biomarkers it could use for other diagnostics.
The company said R&D spending decreased to $1.9 million from $3 million year over year while losses rose to $6 million from $5.5 million in the year-ago period.
Ciphergen said it had around $13.5 million in cash and cash equivalents as of March 31. An SEC filing said this balance “may not be sufficient to fund planned expenditures" and "raises substantial doubt about our ability to continue as a going concern."
Page said in a recent conference call that the company may seek to find ways to raise extra funds, whether from public or private sources, BioCommerce Week sister publication ProteoMonitor reported two weeks ago.
During the presentation, Page said if the company has to look outside for capital, Ciphergen has "a lot of opportunities, we're extremely well positioned after this past year. I think it's our job to continually look at these and opportunistically fund our operations going forward."

Nanogen Files $50M Shelf Registration
Nanogen said last week that it plans to sell up to $50 million in stock, debt securities, and warrants under a shelf registration process that enables the size, price, and terms to be determined at the time of sale.
In a document filed with the US Securities and Exchange Commission on May 25, Nanogen said that under the shelf process, “we may from time to time sell any combination of securities described in this prospectus in one or more offerings, up to a total dollar amount of $50,000,000.”
The company said it plans to use the proceeds for working capital, acquisitions, and other general corporate purposes, including sales and marketing support, R&D, and, “if opportunities arise, to acquire businesses, products, technologies or licenses that are complementary to our business and make strategic investments in businesses complementary to our business.”

The Scan

Study Finds Sorghum Genetic Loci Influencing Composition, Function of Human Gut Microbes

Focusing on microbes found in the human gut microbiome, researchers in Nature Communications identified 10 sorghum loci that appear to influence the microbial taxa or microbial metabolite features.

Treatment Costs May Not Coincide With R&D Investment, Study Suggests

Researchers in JAMA Network Open did not find an association between ultimate treatment costs and investments in a drug when they analyzed available data on 60 approved drugs.

Sleep-Related Variants Show Low Penetrance in Large Population Analysis

A limited number of variants had documented sleep effects in an investigation in PLOS Genetics of 10 genes with reported sleep ties in nearly 192,000 participants in four population studies.

Researchers Develop Polygenic Risk Scores for Dozens of Disease-Related Exposures

With genetic data from two large population cohorts and summary statistics from prior genome-wide association studies, researchers came up with 27 exposure polygenic risk scores in the American Journal of Human Genetics.