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Predictive Biosciences Licenses DNA Biomarker FGFR3 for Bladder Lexington, MA - December 11, 2009 - Predictive Biosciences today announced it has entered into a licensing agreement with Paris-based Institut Curie, Centre National de la Recherche Scientifique (CNRS), and the Assistance Publique - Hôpitaux de Paris (AP-HP), for exclusive rights to diagnostic use of Fibroblast Growth Factor Receptor 3 (FGFR3), an important and well-established DNA biomarker strongly associated with the presence of bladder cancer. Financial terms of the licensing agreement were not disclosed. Predictive is developing and plans to commercialize a non-invasive urine-based diagnostic test for bladder cancer that will combine detection of FGFR3 mutations and matrix metalloproteinase (MMP) protein biomarkers. The combination of these DNA and protein biomarkers can enhance ability of the assay to determine, with high sensitivity and high specificity, the presence or absence of all stages and grades of bladder cancer. The FGFR3 gene is located at chromosome 4p16.3 and mutations have been shown to be associated with early stage/early grade bladder cancer with up to 80 percent of low grade Ta tumors showing mutation. FGFR3 mutations have also been associated with a lower rate of bladder cancer recurrence and are detectable in the urine of bladder cancer patients, making this an attractive non-invasive DNA marker. Predictive believes that an FGFR3 assay could be used to detect lower stage/grade bladder cancers which have been difficult to detect with other biomarkers. “The combination of protein and DNA markers allows us to take advantage of both the high sensitivity of protein biomarkers and the exquisite specificity of DNA markers such as FGFR3,” said Anthony Shuber, co-founder and chief technology officer for Predictive. “We anticipate introducing, for the first time, a non-invasive diagnostic assay capable of determining with near 100 percent certainty that disease is or is not present, prior to directing patients toward invasive standard-of-care surgical procedures such as cystoscopy.” Predictive has recently initiated two large, prospective clinical trials in the U.S., each enrolling approximately 1,000 patients at multiple sites and expected to complete in 2010. One trial is designed to detect recurrent bladder cancer in previously diagnosed patients. The other is evaluating individuals with hematuria (blood in urine) to determine presence or absence of bladder cancer. Two recent publications – Predictive’s own research in the November issue of the Journal of Urology, and an article in the October 21 issue of the Journal of the American Medical Association – underscore the unmet need that exists for new, more effective and more cost-effective approaches to cancer screening, early detection and prevention; specifically, those that employ biomarkers to discriminate minimal-risk from high-risk disease. Predictive’s novel Clinical Intervention Determining Diagnostic™ (CIDD) platform for non-invasive cancer screening and management is directly addressing this need. “We are pleased to be taking this important step towards our goal of developing and commercializing a clinically valuable bladder cancer assay on a global basis. We look forward to extending our collaborations with key clinical sites and opinion leaders in urologic oncology,” said Eugene Chiu, vice president of business development for Predictive. “This unique FGFR3 DNA marker, in-licensed from leading European cancer research institutions, will be leveraged by Predictive’s proprietary clinical approaches and assay development expertise,” he added “We are pleased to provide an exclusive license to FGFR3 to Predictive Biosciences, an emerging leader in the field of biomarker-based cancer diagnostics. We are confident that the company’s development of non-invasive assays employing FGFR3 can lead to a significant improvement in patient care on both sides of the Atlantic,” said Damien Salauze, vice president of business development & licensing at Institut Curie, which represents the academic consortium owning the intellectual property on FGFR3. Predictive Biosciences continues to seek biomarker and diagnostic assay in-licensing opportunities to further expand its innovative portfolio of clinically valuable diagnostic assays, which integrate unique biomarker combinations of well-validated biomarkers such as FGFR3 with cutting-edge detection technologies. About Institut Curie About CNRS About Paris Public Hospital Authority About Predictive Biosciences ### Contacts: Media Contact: Predictive Biosciences, Inc.
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