Leica Biosystems, Nussloch, Germany, and Advanced Cell Diagnostics Inc (ACD), Hayward, Calif, have announced a comprehensive partnership to develop and commercialize tissue-based diagnostic tests based on ACD’s RNAscope in situ hybridization (ISH) assays and performed on Leica’s Bond advanced clinical staining instruments. The agreement supports Leica’s development and commercialization of fully automated RNAscope-based companion diagnostics in partnership with biopharmaceutical companies.
The combination of ACD’s RNAscope technology with Leica’s fully automated pathology solutions aims to integrate the power of new RNA-based biomarker tests into the existing pathology workflow. The tests developd under the partnership will be cobranded and commercialized exclusively by Leica for use in clinical laboratories around the world.
RNAscope LS probes and reagents, running on the research use only Bond RX instrument, will also be upgraded to ready-to-use kits with streamlined software. RNAscope LS products will continue to be branded and commercialized exclusively by ACD.
“We’re very excited about the deepening partnership with Leica Biosystems,” says Yuling Luo, PhD, president and CEO of ACD. “The adoption of RNAscope technology onto Leica Biosystems’ advanced clinical staining instruments creates a new paradigm for tissue-based diagnostics.”
“Leica Biosystems is excited to expand the successful partnership with ACD in order to better serve our customers, many of whom are already enthusiastic users of the RNAscope technology,” says Colin White, vice president of advanced staining at Leica Biosystems. “This partnership will create a powerful platform for the delivery of novel cancer diagnostics in a fully automated workflow environment.”
ACD’s RNAscope technology enables the visualization of target RNA molecules in any cell for tissue-based biomarker analysis. The RNAscope LS assays jointly launched by ACD and Leica Biosystems in 2014 have been adopted for use in preclinical and translational research and for patient selection in clinical trials. Building on this success and customer demand for robust, automated RNAscope tests for late-stage clinical trials and regulatory approval, the two companies will expand their partnership into clinical diagnostics with commercialization expected in the first half of 2016.