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Gen-Probe, 3M, California Department of Health, Med BioGene, Duke, Clinical Data, Qiagen, Third Wave, National Cancer Institute

Gen-Probe, 3M End Collaboration to Develop Molecular Dx Tests
Gen-Probe and 3M announced this week that they have disbanded their collaboration to develop molecular diagnostic tests for healthcare-associated infections.
The firms had been evaluating whether they could combine Gen-Probe’s nucleic acid testing technologies with 3M’s microfluidics instrument platform but found the technologies to be technically incompatible.
San Diego-based Gen-Probe was responsible for assay development, which was funded by 3M. St. Paul, Minn.-based 3M also agreed to pay Gen-Probe milestones based on technical and commercial progress. The first of these milestone payments was made to Gen-Probe in the fourth quarter of 2007.
“We intend to evaluate the merits of developing molecular tests for HCAIs to run on our next-generation automated instruments,” Steve Kondor, Gen-Probe’s senior vice president of sales and marketing, said in a statement.
Gen-Probe said in a filing with the US Securities and Exchange Commission this week that based on the termination of the pact it expects to report $2.7 million of previously deferred revenue during the second quarter. In addition, the firm said that for fiscal 2009 the absence of reimbursement from 3M would cut its collaborative research revenues by roughly $4 million.
Gen-Probe, which is mostly known for its molecular blood-screening tests, has recently been looking for ways to expand its footprint in the molecular diagnostics market. In addition to the collaboration with 3M, the firm recently took a non-exclusive license to Xceed Molecular’s Flow-Thru Chip technology for use in developing next-generation multiplexed molecular diagnostic products.
Two weeks ago, the firm also lodged a counter-bid to Solvay’s offer to acquire Belgian molecular diagnostics company Innogenetics. Gen-Probe is offering to pay €215 million ($334 million) in cash, or €6.10 a share, which would best an April offer of €5.75 a share from drug maker Solvay.
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.

California Sends Warning Letter to Consumer Genetic Testing Firms
The State of California is trying to keep consumer genetic testing companies from offering their services to the state’s residents and last week sent letters to 13 firms saying they are violating state law, California Department of Health spokesperson Lea Brooks told Pharmacogenomics Reporter sister publication GenomeWeb Daily News this week.
The state will not disclose the names of the firms to which it has sent letters, or which laws their services violate, until the companies in question verify with the state that they have received the warnings, Brooks said.
With the move to begin regulating consumer genomics companies in the state, California follows New York State, which less than two months ago warned 23 companies that they must have permits to offer their services to New Yorkers.
New York’s warning letter was a shot across the bow not only to new companies, such as Navigenics and 23andMe, that last year entered into the fledgling field of consumer genomics, but also to technology suppliers Affymetrix and Illumina, which make the tools the testing companies use.
Whether California is focusing on consumer genomic testing companies or if it has broadened its authority to include technology suppliers will not be known until the authorities release the names of the companies it is contacting. California authorities also have not said whether information has been referred to the state’s Attorney General for further action.
One offense that genetic testing companies could commit would be to sell their products to California citizens over the internet without the request or counsel of a doctor, California Department of Public Health official Karen Nickel told last week. Another problem, Nickel said, could be that the companies’ tests have not been validated for accuracy or for clinical utility, which is required under California law.
Concerns over marketing genomic data to consumers and assertions about the ability of tests to predict disease risk were sharply rendered in January by Muin Khoury, director of the National Office of Public Health Genomics at the US Centers for Disease Control and Prevention.
After publishing a critical op-ed in the New England Journal of Medicine with two other authors, Khoury told GWDN that consumer genomics as it is today should be considered “recreational genomics,” and that the field was premature and consumers were not ready to receive the “alphabet soup” of genomic information they were buying.
To Khoury and his fellow NEJM writers, the problem of how to show the clinical usefulness of these genomics offerings would prove to be the most critical.
“The bottom line here is that people are beginning to be concerned that there may be more harm than benefit,” Khoury said.

Med BioGene, Duke Expand Lymphoma Dx Collaboration
Med BioGene said this week that it has expanded its lymphoma diagnostics collaboration with Duke University to include additional collaborators from Northwestern University, Indiana University, and the University of Hong Kong.
Vancouver, BC-based Med BioGene said the expansion of the collaboration was facilitated through Duke’s establishment of the Working Group in Hematologic Malignancies. The first project of the group is to develop genomic-based tests for lymphoma, including Med BioGene’s LymphExpress Dx.
Med BioGene and Duke formed their collaboration in March 2007 to develop and validate biomarkers for lymphoma and leukemia. Under that collaboration, Duke is providing samples for Med BioGene’s gene expression-profiling system.
Erinn Brishko, CEO of Med BioGene, said that the expanded alliance “provides a significant base of expertise in all required areas and patient samples for analysis.”

Clinical Data's Q4 Revenues Rise 9 Percent; Trims Net Loss
Clinical Data this week reported that its fourth-quarter revenues rose 9 percent and that it trimmed its net loss for the quarter by 13 percent.
The Newton, Mass.-based firm brought in total revenue of $7.8 million for the three months ended March 31, compared with revenues of $7.1 million in the fourth quarter of 2007. The company said that its PGxHealth unit brought in revenues of $1.5 million for the quarter, while its Cogenics unit had revenues of $6.2 million.
Clinical Data’s net loss fell to $14.7 million, or $.70 per share, compared to a net loss of $16.9 million, or $1.14 per share, for the fourth quarter of 2007.
Its R&D costs tripled to $6.1 million from $2 million, while its SG&A expenses climbed 10.1 percent to $10.9 million from $9.9 million.
For full-year 2008, Clinical Data’s revenues increased 7.6 percent to $34 million from $31.6 million. The PGxHealth unit had full-year sales of $5.1 million, and Cogenics had revenues of $28.9 million.
Clinical Data’s fiscal 2008 net loss dropped 5.9 percent to $35.3 million, or $1.85 per share, from $37.5 million, or $2.65 per share, in 2007.
The firm’s R&D expenses rose 60.3 percent to $18.6 million from $11.6 million. Its SG&A costs increased 17.7 percent to $37.3 million from $31.7 million.
Clinical Data finished its fiscal 2008 year with cash and cash equivalents of $54.8 million.

Qiagen Seeks Reinstatement of Patent Suit Against Third Wave
Qiagen said last week that it has filed a brief with the US Court of Appeals seeking reinstatement of its patent infringement suit against Third Wave Technologies.
The appeal moves the case that was originally heard before the US District Court for the Western District of Wisconsin to the federal appeals court.
The dispute over patents covering human papillomavirus testing technology began in early 2007, when Digene — which has since been acquired by Qiagen — filed suit against Third Wave for infringing US Patent No. 5,643,715, entitled “Human Papillomavirus Type 52 DNA Sequences and Methods for Employing the Same.” The patent is assigned to Georgetown University and has been exclusively licensed to Digene.
In March, Third Wave countersued for “monopolistic abuse,” noting that its claims were “based on Digene’s repeated abuse of its substantial market power … and the direct and substantial antitrust injury to Third Wave and consumers resulting directly from Digene’s anti-competitive conduct.”
Last July, the US District Court in Wisconsin agreed with Third Wave’s definitions for each of the disputed patent claims in its suit against Digene and denied a request by Digene to reconsider the ruling. Qiagen officials subsequently said that they would appeal the claims-construction ruling.
In a statement issued last week, Qiagen said that in its filing with the appeals court it outlined several specific claims constructions that it wants changed from the district court’s ruling. It said that Third Wave has 40 days to respond to its filing.
“We have spent considerable resources to develop the most extensive HPV intellectual property portfolio in the industry,” Qiagen CEO Peer Schatz said in a statement. “We believe in the strength of our claims and remain committed to vigorously enforcing our intellectual property rights.”
Madison, Wis.-based Third Wave recently filed for regulatory clearance of two HPV molecular tests with the US Food and Drug Administration. Qiagen already sells its molecular diagnostic tests for HPV in both the US and Europe.
Earlier this week, medical imaging and diagnostics firm Hologic said that it will acquire Third Wave for $11.25 per share, or $580 million.

NCI Renews Cancer Biomarker Research Support Program
The National Cancer Institute is continuing its support for a program under which cancer researchers can receive assistance in conducting validations of biomarker programs.
The NCI said last week that the goal of the Program for Rapid, Independent Diagnostic Evaluation, or PRIDE, is to help researchers advance biomarkers from the lab to clinically viable tests through cross-laboratory validation. The PRIDE program’s efforts include the development, refinement, and use of assays, reagents, methods, and tests.
The PRIDE program is part of the NCI’s Early Detection Research Network. The EDRN began in 2000 to help investigators with rapid evaluation of the reproducibility, portability, and precision of their technologies and biomarker assays. It will be supported by NCI for another year, according to Donald Johnsey of the NCI’s Division of Cancer Prevention.
More information about the PRIDE program can be found here.

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