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Leica Biosystems and Advanced Cell Diagnostics Partner

To Develop and Commercialize RNAscope-based Diagnostic and Companion Diagnostic Tests

Leica Biosystems and Advanced Cell Diagnostics

Leica Biosystems, a global leader in anatomic pathology solutions and workflow automation, and Advanced Cell Diagnostics, Inc. (ACD), a world leader in RNA biomarker analysis for precision medicine, today announced a comprehensive partnership to develop and commercialize tissue-based diagnostic tests based on ACD's RNAscope in situ hybridization (ISH) assays on Leica Biosystems' BOND clinical advanced staining instruments. The agreement supports Leica Biosystems' development and commercialization of fully automated RNAscope-based companion diagnostic (CDx) tests in partnership with biopharmaceutical companies.

The combination of ACD's RNAscope technology with Leica Biosystems' fully automated pathology solutions allows companies and laboratories in clinical markets to integrate the power of new RNA-based biomarker tests into the existing pathology workflow. These tests will be co-branded and commercialized exclusively by Leica Biosystems for use in clinical laboratories around the world.

The market-leading RNAscope LS probes and reagents, running on the Research Use Only BOND RX instrument will also be...

"We're very excited about the deepening partnership with Leica Biosystems. The adoption of RNAscope technology onto Leica Biosystems' clinical advanced staining instruments creates a new paradigm for tissue-based diagnostics," said Dr. Yuling Luo, President and CEO of ACD. "For the first time, diagnostic test developers in biopharmaceutical companies and pathology laboratories will be able to develop and commercialize novel tissue diagnostics with unprecedented ease, speed and performance."

Colin White, VP of Advanced Staining at Leica Biosystems added, “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. 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, transforming tissue-based biomarker analysis and providing breakthrough solutions for clinical diagnostics and precision medicine. The RNAscope LS assays jointly launched by ACD and Leica Biosystems in 2014 have been rapidly adopted by major biopharmaceutical companies and leading research institutions, 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.

About Leica Biosystems
Leica Biosystems is a global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. Leica Biosystems provides anatomic pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 7 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany.

About Advanced Cell Diagnostics
Advanced Cell Diagnostics, Inc. (ACD) is a world leader in RNA biomarker analysis for precision medicine, providing the most advanced RNA analysis solutions for cell and tissue based diagnostics in molecular pathology. Its proprietary award-winning RNAscope technology is capable of detecting and quantifying RNA biomarkers with single-molecule sensitivity and single-cell resolution in routine clinical specimens. The technology has been employed in hundreds of peer-reviewed publications by a rapidly growing customer base of thousands of active users, including all of the top global biopharmaceutical companies and world-leading academic institutions. ACD builds strategic alliances with its customers and partners to develop companion diagnostic tests for existing and emerging therapeutics. ACD also pursues internal programs to develop and commercialize proprietary cancer diagnostic tests.

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