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Rosetta Genomics Signs On Two CLIA Labs To Distribute Its First microRNA-Based Dxs

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Rosetta Genomics said this month it has signed on clinical laboratory improvement amendments-certified laboratories at a pair of US medical schools to distribute its first microRNA-based cancer diagnostics.
 
Earlier in the month, Rosetta said it has submitted for approval to the New York State Department of Health its first test, which is designed to distinguish squamous from non-squamous non-small cell lung cancer.
 
If approved, the test, developed by Columbia University Medical College, will be sold nationwide through CUMC’s CLIA-certified High-Complexity Molecular Pathology Laboratory.
 
And last week, Rosetta said it has signed on the University of California-Irvine School of Medicine’s CLIA lab to develop and validate the lung cancer test, and to develop and validate two tests: one to distinguish mesothelioma from adenocarcinoma, and another to identify cancers of unknown primary origin.
 
Rosetta expects to submit these tests for regulatory approval in the US later this year, which may involve partnerships with CLIA-certified laboratories at other US medical schools or research institutions, Ronen Tamir, executive vice president for marketing and communications at Rosetta, told BTW last week.
 
“We’re aiming to have broad coverage in the US to make it easier for doctors and patients to have access to these tests,” Tamir said.
 
CUMC MPL
 
The CUMC MPL arrangement is academic tech transfer in reverse: instead of a university or non-profit research institute developing and licensing a technology to a company to market it, the CUMC MPL, which Tamir said acts “almost like a separate commercial body within the university,” has developed and validated the test and will commercialize it.
 
According to Tamir, “basically the test belongs to [CUMC MPL] from a CLIA point of view. The CLIA regulation states very clearly that the test has to be developed and validated in the lab that is going to perform it, market it, and sell it.”
 
Donna See, a health sciences licensing officer for CU Science and Technology Ventures, told BTW in an e-mail that the project is a good example of how companies and academics can work together to turn scientific discoveries into clinical services.
 
“This is not a typical technology transfer out-licensing deal, where a company licenses our technology and develops and sells it on their own,” See said. “This is different in that … we are able to assist in a very practical way with getting a needed service/product to patients.”
 

“We know that oftentimes hospitals prefer to use local or closer institutions, so this is why we went to UC-Irvine, to cover the West coast, and increase the capacity of the tests to be performed. And we will evaluate to see how we can increase this capacity further.”

In order to do this, Columbia had to obtain all necessary licenses including a license from Rosetta to use certain of its miRNA technology, See said.
 
Tamir and See declined to provide specific financial details around the licensing agreement or potential sale of a diagnostic product, although Tamir said that Columbia will “receive the sample, perform the test, bill the hospital or the doctor that sends them the test, and basically pay Rosetta after deducting expenses.”
 
Rosetta said that the test that Columbia hopes to offer classifies squamous cell carcinoma of the lung with a specificity of 90 percent and a sensitivity of 96 percent.
“The importance of accurately differentiating squamous cell from non-squamous NSCLC has recently been an issue of great interest and is gaining importance as new targeted therapies for NSCLC enter the market or proceed to late stages of development,” Dalia Cohen, chief scientific officer of Rosetta Genomics, said in a statement.
 
Rosetta, which has offices in Rehovot, Israel, and Jersey City, NJ, chose CUMC to develop and market the lung cancer test “first, because of its reputation, and second, because it is licensed in the state of New York,” Tamir explained.
 
The CUMC MPL provides nucleic acid-based testing in the fields of molecular oncology and molecular genetics. It has New York state permits for genetic testing, molecular oncology, molecular and cellular tumor markers, and virology, and currently performs more than 30,000 tests per year in these categories.
 
If New York State approves the lung cancer test, CUMC MPL will offer the tests to hospitals and individual doctors nationwide.
 
UC-Irvine
 
Under Rosetta’s agreement with the UC-Irvine School of Medicine, the university will help further develop and validate the lung cancer test, the mesothelioma/adenocarcinoma test, and a test for identifying the origin of a metastasis in patients presenting with CUP.
 
“This agreement is key to the successful implementation of our business strategy for our diagnostic products,” Rosetta CEO Amir Avniel said in a statement.
 
According to Tamir, the deal jibes with Rosetta’s belief “that oftentimes hospitals prefer to use local or closer institutions,” and UC-Irvine will be able to cover the West coast “and increase the capacity of the tests to be performed. And we will evaluate to see how we can increase this capacity further.”
 
Specific terms of the collaboration were not disclosed, but Tamir said that the arrangement would be similar to the CUMC deal.
 
Tamir also said that Rosetta will likely ink similar collaborations with more medical schools or research institutes in the future to continue expanding the availability of diagnostics based on its technology throughout the US, and that it very likely would be able to offer more than one test through each institution.
 
Rosetta stands to benefit financially as each test based on its technology is approved for sale at one or more CLIA labs, but a cut of its profit will also be returned to the universities or research institutions from which it has licensed intellectual property related to its core miRNA technology platform.
 
Tamir said that of the miRNAs listed in miRBase, the database of published microRNA sequences and associated annotation curated by the Wellcome Trust Sanger Institute, about 42 percent were discovered by Rosetta, for which the company has applied for patents.
 
Tamir also estimated that about 13 percent of the sequences were discovered in collaboration with Rosetta by Johns Hopkins University, which has taken an exclusive license to the miRNAs; and a smaller percentage was discovered by scientists at Rockefeller University and the Max Planck Institute, to which Rosetta has taken non-exclusive licenses. Rosetta will pay undisclosed royalties and milestone fees to these institutions as diagnostics based on its miRNA technology are brought to market.
 
Rosetta has also developed its own IP around its process for “very specifically, very quickly, and very accurately extracting the mRNAs and identifying them,” and for allocating mRNAs into specific disease areas, Tamir said.
 
“Basically licensing from other academic institutions is only a competitive matter,” he said.
 
To date, Rosetta has forged partnerships with CUMC in the area of leukemia and non-Hodgkin’s lymphoma; with New York University Medical Center to develop a line of early-detection diagnostics for melanoma, and lung cancer and mesothelioma; and with the Henry Ford Hospital in Detroit for brain cancer.
 
Tamir did not provide an update regarding the status of these development agreements.

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