Lab21 expects to launch first CE-marked companion dx using the technology this year.
Lab21 acquired a worldwide license to use Cooperative Diagnostics’ real-time PCR technologies for the development of specific biomarker-based tests in the fields of oncology and infectious diseases. The firm says it plans to launch the first CE-marked companion diagnostic assay using the technology during the first half of 2012.
Initial work indicates that Cooperative Diagnostics’ technology significantly reduces assay development times and generates assays that perform better than existing gold standards in terms of sensitivity and specificity, claims Berwyn Clarke, Ph.D., Lab21 CSO. “We expect the technology to deliver a substantial number of new assays in the first 12 months, and that it will be of significant interest to pharmaceutical companies needing to fast-track companion diagnostic development.”
Cooperative Diagnostics has developed a suite of products for real-time PCR, including probes, primers, and hot-start technology for reducing non-specific amplification initiated during set-up. The firm offers its Simplex real-time PCR tests in kit form with ready-to-use master mix, which can be used on most instrumentation, as well as a real-time PCR custom-design service for assays ranging from infectious diseases to specific cancer marker diagnostics.
Molecular diagnostics firm Lab21 provides diagnostic services for clinicians and the pharma industry through its clinical laboratories division that has fully accredited laboratories in the U.S. and U.K., and is also developing a portfolio of molecular assays and infectious disease tests for screening blood supplies.