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Stratagene Builds on Molecular Dx Alliances with Licensing Deal for Aros Bladder Cancer Tests

In the latest step in its evolving molecular diagnostics strategy, Stratagene last week obtained exclusive rights from Aros Applied Biotechnology to evaluate and license certain gene groups that may be used as cancer biomarkers.
As revenues have declined from sales of its legacy research products, Stratagene has increasingly focused on developing instruments and reagents for diagnostics and applied markets, which could offer greater growth potential. The deal with Aros is a prime example of this strategy and is the latest in a string of collaborations intended to establish the firm’s presence in the nascent molecular diagnostics market.
Under the terms of the agreement, Stratagene has the right to evaluate and obtain exclusive licensing rights to a set of gene groups that Stratagene claims have been shown to have predictive capabilities for bladder cancer. The firm said it would internally develop diagnostic kits that incorporate the biomarkers.
According to Stratagene President and CEO Joe Sorge, the current test developed by Aros targets bladder cancer, particularly in the transition between stages T1 and T2, “which is where therapeutic intervention decisions are critical.”
He wrote in an e-mail response to questions from BioCommerce Week, “The ‘grade’ of the tumor cells, as determined by a pathologist examining the appearance of the cells under a microscope, can be somewhat predictive as to the likelihood of progression.  However, grading the cells alone is not fully predictive. The Aros test provides additional predictive power, and when used in conjunction with the grade score is very predictive of progression.”
Sorge said that that combination of information could help a physician in “making decisions such as how frequently to follow the patient using cystoscopy, which requires hospitalization and anesthesia, or whether to remove the bladder surgically as a proactive step.”
Financial terms of the collaboration were not released; however, Sorge noted that the option agreement is not limited to any particular type of cancer. He also said that the firm would evaluate the technology for the next month before taking a license.
Stratagene also will collaborate on further development of the tests with Torben Orntoft, co-founder and CEO of Aros, chief physician in the department of clinical biochemistry at Aarhus University Hospital, and professor of molecular cancer diagnostics at the University of Aarhus in Denmark.
Sorge said it would take about a year to validate the tests’ efficacy using QPCR in an independent set of tumor samples. “Afterward, the test could be available to reference labs,” he wrote. “Sales of kits will require regulatory approval, which will take longer.”
He said Stratagene is not aware of any marketed molecular diagnostic tests covering bladder cancer. “The closest test is Genomic Health’s breast cancer predictive test,” he said.
Building On Established Molecular Dx Partnerships
The eventual sale of the cancer tests may benefit from a joint development and licensing pact Stratagene signed last month with Merck subsidiary Rosetta Inpharmatics to create an automated instrument that can isolate nucleic acids from clinical samples (see BioCommerce Week 8/16/2006). The companies intend to jointly develop an instrument and a single-use consumable that Stratagene will manufacture and sell to its current customer base and to potential customers in the pharmacogenomics market.
“While we anticipate healthy revenue from the sales of this automated solution in 2007, we foresee substantial long-term revenue potential as the adoption of nucleic acid biomarkers in standard medical practice begins to take place toward the end of the decade,” Sorge said during the firm’s second-quarter conference call last month.
The Aros alliance fits in with Stratagene’s strategy of developing diagnostic kits in house while it pursues external development deals with larger diagnostic partners, including Bayer Healthcare and Focus Diagnostics.

“The Aros test provides additional predictive power, and when used in conjunction with the grade score is very predictive of progression.”

Focus is developing diagnostic assays based on Stratagene’s FullVelocity quantitative PCR technology under a deal inked in December (see BioCommerce Week 12/8/2006). Herndon, Va.-based Focus, which operates a national reference lab that offers more than 1,200 infectious disease tests, received a non-exclusive license to the FullVelocity technology, and Stratagene said it intends to help the company develop molecular diagnostic kits and products. Stratagene will manufacture any diagnostic products that arise from the collaboration, and Focus will commercialize them globally.
Stratagene hopes to begin testing assays for regulatory clearance early next year and to launch some of the products in 2007, Sorge said during the conference call.
Under the collaboration signed with Bayer in March, the German diagnostics giant will sell customized versions of Stratagene’s Mx3005p instruments to clinical labs for molecular diagnostics testing worldwide (see BioCommerce Week 3/8/2006). Bayer is currently funding software development for the instruments, and will begin developing instruments based on Stratagene’s technology in the latter part of 2006.
Sorge noted in his e-mail this week that Stratagene has not yet made any commitments to commercialize Aros’ technology with any partners. ”However, several companies have expressed an interest in cancer tests in general” from the firm, he said.

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