January 26, 2016

NEWCASTLE UPON TYNE, UK & HAYWARD, CALIFORNIA, USA, January 26, 2016 – Leica Biosystems, a global leader in anatomical pathology solutions & 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 the 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 labs around the world.

The market-leading RNAscope LS probes and reagents running on the Research Use Only BOND RX instrument will also be upgraded as ready-to-use kits with streamlined software, to make the system more robust and easy to use. The RNAscope LS products will continue to be branded and commercialized exclusively by ACD. The availability of RNAscope technology on both research and clinical advanced staining platforms provides a seamless path for diagnostic test developers to translate their research to the clinic.

"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 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 molecule 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 adopted rapidly 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 customers' 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 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.Learn more about ACD and RNAscope technology at www.acdbio.com.

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 anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Leica’s 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. Visit www.leicabiosystems.com for more information.

Media Contact – ACD:
Steve Chen, Ph.D., Chief Operating Officer
+1 (510) 259-9802

Media Contact – Leica Biosystems:
Kristin O'Neill, Global Brand Marketing Manager
+1 847 821 3537

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