Only FDA-Cleared CTC test to join Company’s Portfolio of Diagnostics

Bologna, Italy and San Diego, CA, Dec 20, 2016 - Menarini-Silicon Biosystems today announced they have signed an agreement to purchase all the assets and relevant business related to the CELLSEARCH^® Circulating Tumor Cell (CTC) system from Janssen Diagnostics, LLC.  CELLSEARCH^® is used to help manage patients with metastatic breast, prostate, and colorectal cancers.  It is the only FDA-cleared CTC test, and has also been approved by China’s FDA for use in monitoring breast cancer patients. Financial details were not disclosed.

CELLSEARCH^® system will join Menarini-Silicon Biosystems’ family of advanced diagnostics, which includes the Company’s flagship DEPArray™ System.  DEPArray™ is a rare-cell detection and isolation technology that is used globally in a number of therapeutic areas, including oncology.  With both DEPArray™ and CELLSEARCH^® in its portfolio, Menarini-Silicon Biosystems will be able to provide CTC detection on an FDA-cleared platform, and give oncologists and researchers access to unparalleled molecular characterization capabilities.  Together, the two technologies provide a unique opportunity to advance next-generation, personalized medicine strategies.

“We are excited to welcome CELLSEARCH^® to the Menarini-Silicon Biosystems portfolio,” commented Lucia Aleotti, Chairman of Menarini Group and Giuseppe Giorgini, CEO, Menarini-Silicon Biosystems.  “The combined capabilities of CELLSEARCH^® together with our DEPArray™ System will enhance our potential to enable meaningful advances in the field of personalized medicine.” 

Under terms of the agreement, when the closing will occur, Menarini-Silicon Biosystems will seek to retain many of the Janssen Diagnostics employees in roles dedicated to CTCs, and assume operation of Janssen Diagnostics’ CLIA-certified laboratory in Huntingdon Valley, Pennsylvania. The two companies will work closely to transition the business across the many global markets where CELLSEARCH® is available.

About CELLSEARCH ^® Technology

Clinical data to date from 28 independent prospective studies involving more than 4,700 patients have validated the clinical performance and value of CELLSEARCH^® CTC testing to predict progression-free survival and overall survival both before and after therapy initiation.  CELLSEARCH^® data have been published in more than 100 peer-reviewed publications.

About the DEPArray™ System

DEPArray™ technology is recognized as the gold standard to isolate single CTCs from enriched blood, with data published in 19 peer-reviewed publications and mentioned in more than 30 review articles. The full synergy between CELLSEARCH^® enrichment and DEPArray™ sorting have been shown to deliver 100% pure cells suitable for very precise and reproducible downstream next-generation sequencing analysis. In addition, DEPArray™ technology has other applications that includes recovery and molecular characterization of pure cell populations from disaggregated formalin-fixed paraffin-embedded (FFPE) specimens, fresh tissues and fine needle aspiration samples.

About Menarini-Silicon Biosystems

Menarini-Silicon Biosystems Inc. is a Menarini Group company, with European headquarters in Bologna and American headquarters in San Diego, California. Menarini-Silicon Biosystems operates in the healthcare sector and in personalized medicine, through the development of technologies and products that help to understand the biological complexity of many pathologies thanks to the study of single cells. For more information www.siliconbiosystems.com

*The DEPArray™ system is for research-use only.