September 2010 Clinical Laboratory News: Industry Profiles

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September 2010: Volume 36, Number 9 


Rules-Based Medicine Receives Award to Develop Cancer Biomarker Assays

Rules-Based Medicine announced it has received an award for about $3 million that will be used to finance the research and development of more than double the number of cancer-associated biomarker assays in its new OncologyMap product. The funding is a Company Commercialization Award from the Cancer Prevention and Research Institute of Texas. According to RBM, the money will be used to carry out a 3-year plan to develop and validate multiplexed immunoassays that measure 150 to180 blood-based biomarkers that the National Cancer Institute thinks may be associated with cancer. The firm believes the final product will include the largest number of quantitative immunoassays available for discovering and approving new diagnostic, prognostic, and companion diagnostic tests for cancer.

Protagen, Mikrogen to Collaborate on Array-based Dx

Protagen announced it will team up with Mikrogen, a German diagnostics firm, to develop an infectious disease diagnostic based on Protagen’s UNIarray platform. “The cooperation with Protagen secures Mikrogen the access to an important and novel technology platform,” said Erwin Soutschek, co-founder and managing director of Mikrogen. The firms have conducted a sufficient study for identifying typical autoantibody signatures in infectious diseases that maybe useful for diagnostic tests. 

Roche Obtains License for PI3K Biomarker

Roche Molecular Diagnostics has acquired a global co-exclusive license from Qiagen for phosphoinositide 3-kinase (PI3K), a biomarker for cancer. The firm hopes to develop real-time and endpoint polymerase chain reaction (PCR) diagnostic assays for PI3K to operate on its cobas 4800 System. “Given the demonstrated predictive value of these biomarkers, developing assays that identify clinically relevant mutations is an area of high priority for Roche,” said Paul Brown, president and CEO of Roche. The firm has a number of programs in the works to develop real-time PCR assays that detect mutations in the PI3K oncogene. Roche also plans to make the PCR assay available to pharmaceutical partners for use in clinical trials. 

Cepheid Files Countersuit against Abaxis Regarding Reagent Patents

Cepheid has filed a countersuit against Abaxis stating that it did not violate any of Abaxis’, patents and that Abaxis filed its suit “without reasonable basis and in bad faith.” Cepheid denies that it breached the licensing agreement, including all of its royalty obligations. According to Cepheid, it was in the process of disclosing the information regarding its current process of manufacturing to Abraxis, which it said was not covered by the patents-in-suit, when Abaxis filed the suit. Abaxis claims that Cepheid has been infringing a suite of patents covering reagents through the sale of its Xpert MRSA test. In the suit, Cepheid also refuted that it has infringed any of the other patents named in the suit, which had been licensed by Abaxis to Cepheid in September 2005. Cepheid is also seeking that the court declare all the patents invalid for failing to meet conditions of patentability established by U.S. law.

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