Vaccines and Molecular Diagnostics
The Centre de Recherche en Infectiologie (CRI) of Laval University has given rise to several commercial ventures, including two diagnostics companies, Infectio Diagnostic (now BD Diagnostics) and GenePOC; instrumentation developers Autogenomics and Silicon Kinetics; as well as Gealth, which developed the vaginal microbicide Invisible Condom® to protect women against HIV infection; Folia Biotech, which is developing vaccines against typhoid fever, influenza, and hepatitis C; Diapedex, a company pursuing R&D on immunomodulatory drugs to control inflammation; and Génocéan, which is applying metagenomics technology to the study of environmental microbiology.
Michel Bergeron, M.D., founding director of CRI describes the next generation of diagnostic products in development as microfluidic centripetal devices, which will automate all of the steps needed for sample preparation, PCR-based DNA amplification, and detection of infectious agents and will be used at the point of care.
Vaccine researchers at CRI are focusing on developing novel adjuvants as well as preventive strategies for leishmaniasis and HIV. Additional research programs target the diagnosis, pathogenesis, and treatment of viral respiratory infections, host-pathogen interactions induced by bacteria, viruses, and protozoa, and the emerging science of glycobiology and the immunomodulatory role of glycoproteins.
DiagnoCure, which develops diagnostic tests and provides cancer-specific laboratory services, is awaiting the results of a large-scale clinical trial of its PCA3 marker for prostate cancer. DiagnoCure has successfully launched a commercial product on the U.S. market—the Previstage™ GCC molecular colorectal cancer staging test.
Previstage detects guanylyl cyclase 2C (GCC), a marker expressed by colorectal tumors that is predictive of recurrence risk, the firm says. An NIH-sponsored study published in February demonstrated a significant association between GCC expression and colorectal cancer prognosis in patients whose lymph nodes showed no signs of metastatic disease on histologic examination. GCC expression in the lymph nodes indicates the presence of cancer cells and is an independent marker of time to recurrence and reduced disease-free survival. The assay can reportedly detect a single cancer cell in up to 10 million normal cells.
About 27% of the “node-negative” patient specimens tested using Previstage are found to be positive for metastatic disease. The company expects interim data in 4Q09 from a five-year prospective study to evaluate whether GCC can detect cancer recurrence following curative surgery or chemotherapy.
DiagnoCure licensed the commercialization rights to its PCA3 urinary marker for prostate cancer to Gen-Probe.
The Progensa® PCA3 assay is used to help determine the need for a repeat biopsy in men with an elevated PSA level and an initial negative biopsy result (approximately 75% of prostate biopsies following elevated serum PSA readings are negative). Gen-Probe’s FDA submission will follow completion of an ongoing 500-man pivotal clinical study.
DiagnoCure acquired the rights to a family of molecular markers called the Shc proteins, and the company is developing Shc protein assays for use in predicting aggressiveness/recurrence risk and response to chemotherapy in five main tumor types, including breast and colon. John Schafer, president and CEO of DiagnoCure, recently reported that at mid-year DiagnoCure had about $20 million in the bank and was exploring strategic alliances in Europe and Asia.
BD Diagnostics, through its BD GeneOhm™ platform, is developing nucleic acid-based diagnostics for the detection and identification of infectious organisms, particularly drug-resistant strains infecting patients in healthcare settings.
BD acquired GeneOhm Sciences in 2006, which had previously acquired Infectio Diagnostics, a spinoff from the Infectious Diseases Research Center at Laval University Hospital. BD’s product portfolio includes five rapid, PCR-based assays for detecting Group B Streptococcus, methicillin-resistant Staphylococcus aureus (MRSA) in nasal specimens, C. difficile toxin B gene in stool specimens, and vancomycin-resistant Enterococcus, and for differentiating Staphylococcus aureus and MRSA in positive blood cultures.
In May 2009, BD announced an agreement with HandyLab, to commercialize the BD GeneOhm assays on a new automated BD MAX™ platform based on HandyLab’s Jaguar instrument. The bench-top Jaguar system provides fully automated clinical sample preparation, nucleic acid extraction, and microfluidic real-time PCR amplification and detection.