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Althea Technologies, Althea Diagnostics, GPPC, NHGRI, Johns Hopkins University, Third Wave Technologies, NCI, Gen-Probe, FDA, Warnex Medical Laboratories, Xenomics, Cepheid, European Union

Althea Technologies Spins out Molecular Dx Business
Pharmaceutical services company Althea Technologies said this week it has spun out its molecular diagnostics and biomarker business into an independent company called Althea Diagnostics. 
The new company, which will be situated at Althea Technologies’ campus in San Diego, will commercialize a quantitative gene measurement technology and will seek to develop other tools and applications aimed at speeding up the development of molecular diagnostic tests.
Althea Diagnostics is developing a test for differential diagnosis of pediatric solid tumors along with other biomarker sets for use in cancer management.
Company Co-founder François Ferre said in a statement that the move to create a diagnostics-focused company was “a situation of technology and timing,” and said the attraction of the molecular diagnostics market was “too strong to resist.”
The spin-out also will continue to offer lab services to pharmaceutical companies and contract research organizations, including its Express Pathway suite, which is used to identify molecules, explore treatment pathways, and build sets of markers that may be of clinical utility.

GPPC to Hold Touring Town Halls on Large-Scale Cohort Studies
The National Human Genome Research Institute has asked Johns Hopkins University’s Genetics and Public Policy Center to do a pilot study on how to engage the public in large cohort, long-term studies on genes and the environment. As part of this effort, GPPC will conduct a series of town hall-style public meetings this spring in five cities around the country.
Working under a $2 million NHGRI grant issued in 2006, the GPPC will conduct meetings of around 200 members of communities in Kansas City, Mo.; Jackson, Miss.; Middletown and Philadelphia, Pa.; Phoenix Ariz.; and Portland, Oregon.
The NHGRI anticipated that the public might have questions and concerns that may hinder their participation in genetic studies. In the RFA that it awarded to the GPPC, NHGRI said it expected to raise concerns about the use of data, privacy protection, open-ended consent, and other concerns.
Through these meetings conducted by the GPPC, the institute hopes to tailor some of its work to communities with special needs, optimize approaches to identifying and contacting family members, and maintain a dialog with participants in terms of the studies’ goals and processes. 

Third Wave's Q4 Revenues up 31 Percent, But Loss Rises on R&D, Litigation Costs
Third Wave Technologies this week reported that its revenue grew nearly 31 percent in the fourth quarter of 2007, but its net loss climbed nearly 72 percent on increased R&D and legal expenses. 
The firm reported Q4 revenues of $8.9 million, compared with $6.8 million in the fourth quarter of 2006. Sales for the recent quarter included clinical product revenue of $7.3 million, a 26 percent rise from $5.8 million in the previous year’s fourth quarter. Research product revenue was $1.6 million, up 65 percent from $954,000 in the fourth quarter of 2006. License and royalty sales were minimal, dropping to $31,000 from $49,000 year over year.
Third Wave posted a net loss of $7.9 million, or $.18 per share, compared with a loss of $4.6 million, or $.11 per share, in the comparable quarter last year.
Research and development spending rose 83 percent year over year to $6.7 million from $3.7 million, while SG&A costs ticked up around 5 percent to $6 million from $5.7 million year over year. The costs of litigation in the fourth quarter of 2007 rose from $171,000 to over $1.8 million.
For full-year 2007, Third Wave reported total revenues of $31.1 million, up 11 percent from revenues of $28 million for fiscal 2006. Clinical product revenues for the full year rose 25 percent to $26.3 million from $20.9 million, while research products revenue fell 32 percent to $4.6 million from $6.8 million. Licensing and royalty revenue increased to $264,000 from $155,000, and the firm reported no grant revenue in 2007 versus $183,000 in 2006.
Research and development spending soared in 2007, rising 83 percent to $22.8 million from $12.4 million, while SG&A costs remained steady at $25.8 million in fiscal 2007 compared with $25.9 million the previous year.
Net loss for fiscal 2007 was down 11 percent to $16.8 million, or $.39 per share, from $18.9 million, or $.45 per share, in 2006. 
Third Wave projected total revenues of between $36 million and $37.5 million for fiscal 2008, with molecular diagnostic revenue growth of around 25 percent to between $33 million and $34.5 million, and research revenue of around $3 million.
The firm finished the year with cash and cash equivalents of $35.7 million.
Third Wave CEO Kevin Conroy said the company is focused on expanding its human papillomavirus diagnostic business globally and plans to make two product submissions to the US Food and Drug Administration for HPV, including a screening test for HPV type 14 and a genotyping test for HPV types 16 and 18. The company also plans to enhance its European distribution network and to grow its molecular diagnostics business, Conroy said in a statement.

NCI Funds Comparative Genetics Research
The National Cancer Institute said last week that it will award up to $15 million over five years to projects that will use comparative genetics to study cancer.
The NCI will grant up to $3 million per year over the next five years to fund between four and six programs that will use humans and one other species in collaborations involving various genetics studies as well as systems biology, mathematical and computational modeling, and computer sciences.
Applicants may request as much as $375,000 annually for up to five years. Letters of intent are due April 14, 2008, and applications are due May 14, 2008.
More information about the NCI grant program can be found here

Gen-Probe Seeks FDA Approval for Donor Blood HBV Assay
Gen-Probe has filed for clearance with the US Food and Drug Administration for additional use of the Procleix Ultrio assay to screen for hepatitis B virus in donated blood, the company said last week.
The company seeks FDA approval that would allow it to administer the assay on its semi-automated platform and on its fully automated, high-throughput TIGRIS system.
Between 2006 and 2007, the FDA cleared the Procleix Ultrio to screen for HIV-1 and HCV in donated blood, plasma, organs, and tissue on both of its systems. However, those clearances did not cover screening for HBV in donated blood because the assay was not tested for HBV yield in donated blood.
The company said that after discussions with the FDA it agreed with the Novartis-owned company Chiron to conduct a post-marketing study to demonstrate the test’s HBV yield capability, and a subsequent screening of 500,000 samples yielded two cases of HBV.
Procleix and Ultrio are property of Novartis, which serves as one of Gen-Probe’s distributors.

Warnex Licenses Xenomics' AML Dx Marker
Warnex Medical Laboratories has licensed from Xenomics the rights to use a marker for acute myeloid leukemia in a diagnostic test, Xenomics said last week.
The agreement gives Warnex nonexclusive rights in Canada to use a recently discovered mutation in the NPM1 gene in a lab service to help doctors diagnose, stratify, and monitor AML patients.
The marker also could help doctors decide which patients are likely to benefit from intensive chemotherapy and those who are less likely to show positive responses to the treatment. The company said the mutation also may be used to monitor AML patients for residual disease during chemotherapy and to stratify patients involved in clinical trials.

EU Clears Cepheid Thrombophilia Tests
Cepheid last week said that European Union regulatory authorities have cleared the firm’s Xpert HemosIL FII & FV assay for marketing.
The assay detects Factor II and Factor V Leiden genetic variations associated with thrombophilia. The test was developed for use on Cepheid’s GeneXpert multiplex molecular diagnostics system.
Cepheid’s exclusive worldwide distributor for hemostasis tests, Instrumentation Laboratory, will begin selling the assay on March 4. It is the first test to be commercialized under a partnership between the firms that was signed in April 2007, and will complement IL’s current line of hemostasis assays including antithrombin, protein C, protein S, homocysteine, and lupus anticoagulants.
"Given the complexity of traditional molecular diagnostics, clinical laboratories currently may wait up to a week for FII and FV genotyping,” Cepheid CEO John Bishop said in a statement. “The Xpert HemosIL FII & FV assay will allow laboratories to perform the test as needed — and integrate the results with other tests — providing physicians a comprehensive thrombophilia profile of their patients.”
The new assays also target a new market for Cepheid, which has concentrated its commercial efforts so far on molecular diagnostic tests for hospital-acquired infections. While the HAI market remains the primary focus of the firm, it also is developing tests for tuberculosis and human papillomavirus.

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