Advanced Cell Diagnostics' RNAscope Technology Supports Biomarker-Selected Phase 2 Clinical Trial of Merrimack Pharmaceuticals' MM-121
March 09, 2015

HAYWARD, CALIFORNIA, March 9, 2015: Advanced Cell Diagnostics, Inc. (ACD) announced today that Merrimack Pharmaceuticals, Inc. is using ACD's RNAscope technology to select patients for its Phase 2 clinical trial of its product candidate MM-121. Merrimack will utilize RNAscope to identify patients with heregulin positive, locally advanced or metastatic non-small cell lung cancer, making this Merrimack's first MM-121 trial to include only patients with a high heregulin biomarker profile. In previous MM-121 Phase 2 clinical trials, heregulin-positive patients, determined by RNAscope, have demonstrated significant therapeutic benefits when treated with a combination of MM-121 and standard therapies.

“Our selection of the RNAscope-based heregulin test for this clinical trial is the culmination of multiple clinical studies in which we evaluated RNAscope. These trials have repeatedly demonstrated the potential of heregulin as a promising biomarker in predicting the therapeutic benefits of MM-121." stated Gavin MacBeath, Senior Vice President of Translational Research at Merrimack. "We believe that the high sensitivity and specificity that RNAscope provides are necessary to identify the patients most likely to benefit from MM-121in this Phase 2 clinical trial. RNAscope's ability to detect heregulin within the confines of tumor cells, compatibility with existing automation instruments and with small tissue specimens such as fine needle aspirates and core needle biopsies were all important considerations in our decision to work with ACD."

"We are delighted that Merrimack has selected RNAscope as the biomarker platform for their MM-121 clinical program. This marks the first of many examples of RNAscope's adoption to support the development of companion diagnostic tools for pharma and biotech companies. We believe that RNAscope's robust capabilities and open platform make it an ideal foundation on which to develop highly capable CDx solutions that maximize trial efficiency by enabling drug developers to more effectively zero-in on those patients most likely to benefit." said Dr. Yuling Luo, Founder, President and CEO of ACD.

For further information please visit www.acdbio.com.

About RNAscope
ACD's RNAscope represents a major technological advance in in situ RNA detection. This patented, breakthrough platform is the first to enable robust single RNA molecule detection in routine formalin-fixed, paraffin-embedded (FFPE) clinical specimens. RNAscope provides rich molecular and morphological information in a single assay to maximize the clinical utility of RNA biomarkers. This is especially true in cancer diagnostics due to the significant intra-tumor heterogeneity and the complex involvement of the tumor microenvironment in tumor growth and therapeutic response. Since its commercialization over three years ago, RNAscope has seen rapid adoption across the globe by all major pharma/biotech companies and leading academic institutions for drug target validation, translational research, and the development of clinical diagnostics and companion diagnostic tests. The RNAscope-based companion diagnostic test under development for Merrimack's MM-121 detects mRNA of heregulin, a ligand for the drug target of MM-121, ERBB3.


About Advanced Cell Diagnostics
Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology, developing cell and tissue based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope assays are currently used by all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.


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

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