Liquid Biopsy Test for Circulating Tumor Cells Marks Its First Entry into U.S. Diagnostics Market

BOLOGNA, Italy, and Philadelphia, PA, April 3, 2017 – Menarini-Silicon Biosystems, Inc. today announced it completed the agreement to purchase all the assets and relevant business related to the CELLSEARCH® Circulating Tumor Cell System from Janssen Diagnostics, LLC. Marking Menarini-Silicon Biosystems’ first entry into the U.S. diagnostics market, the acquisition includes the CELLSEARCH® Circulating Tumor Cell Test — the first and only clinically validated blood test cleared by the U.S. Food and Drug Administration for detecting and enumerating circulating tumor cells (CTCs) to help manage patients with metastatic breast, prostate, and colorectal cancers. The test is also approved by the China Food and Drug Administration for use in monitoring metastatic breast cancer patients.

Under the agreement, Menarini-Silicon Biosystems will assume operations of the seller’s CLIA-certified laboratory in Huntingdon Valley, PA. A. Menarini Diagnostics, a Menarini Group company, will operate the business in Europe, while Menarini Silicon Biosystems Inc. will lead the business in the U.S. and the rest of the world. Not all operations will be transferred simultaneously, the present closing relates to US and Europe while the closing for the rest of the world will follow at a later stage. Financial details were not disclosed.

Working closely with clinical investigators and pharmaceutical companies, the acquisition is part of the company’s strategic objective to develop companion diagnostics that allow selecting patients more likely to respond to targeted drug treatments, and that accelerate the validation of personalized therapies.

The CELLSEARCH® product line, which includes the CELLTRACKS® AUTOPREP SYSTEM, the CELLSEARCH® Analyzer II and the CELLSEARCH® CTC Kit, will join Menarini-Silicon Biosys­tems’ growing family of advanced diagnostics led by its flagship DEPArray™ NxT System (for research use only). The DEPArray NxT digital cell-sorting and isolation system, complemented by the Ampli1 kits, enable rare-cell isolation and genetic analyses, and are used worldwide in clinical research to achieve molecular characterization with single-cell precision.

“The integration of CELLSEARCH® and DEPArray provides an end-to-end workflow solution for the enumeration, isolation, and molecular characterization of CTCs,” added Giuseppe Giorgini, CEO of Menarini-Silicon Biosystems. “This will provide researchers and oncologists with access to unparalleled precision in the molecular characterization of CTCs from a simple blood test that will help drive their clinical utility and correlation with the effectiveness of specific therapies.”

CTCs Liquid Biopsy

CTCs are cancer cells that are released and disseminated into the blood stream and lymphatic system by advanced cancers. A liquid biopsy is a test to detect these cells that provides a minimally invasive alternative to a solid tumor biopsy — especially when suspected cancer tissue is not accessible. Providing valuable information to make a clinical decision, the CELL­SEARCH® CTC test is a blood test performed at a reference laboratory using the CELLSEARCH® Circulating Tumor Cell System. CELLSEARCH® CTC testing can be used throughout a given therapy to monitor a patient’s status by showing if their prognosis is favorable.

To date clinical data 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

Recognized by leading centers of excellence for delivering rare cells with 100% purity, the DEPArray is the only image-based digital cell-sorting and isolation platform that enables researchers and clinicians to conduct molecular analyses on live or fixed cells with single-cell precision. The technology represents the highest benchmark for isolating single CTCs from enriched blood, supported by data published in 24 peer-reviewed publications and mentioned in more than 30 review articles.

The integration of CELLSEARCH® enrichment and DEPArray sorting have been shown to deliver 100% pure cells suitable for very precise and reproducible downstream next-generation sequen­cing analysis. DEPArray technology has other applications that include 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 and A. Menarini Diagnostics

Menarini-Silicon Biosystems, Inc. develops technologies and products that help to understand the biological complexity of disease through the study of single cells. Moving single-cell analysis from bench to bedside, the company is focused on fulfilling the vision of precision medicine — disease prevention and treatment that considers each person’s genetic variability. The company is a wholly owned subsidiary of The Menarini Group with European headquarters in Bologna, Italy and U.S. headquarters in San Diego. Menarini Group with a heritage spanning 130 years and over 16,000 employees in more than 100 countries is a privately held multinational pharmaceutical, biotechnology and diagnostics company based in Florence, Italy. A. Menarini Diagnostics was founded in 1976 as a wholly owned subsidiary of The Menarini Group focused on the in vitro diagnostics European market, where it works through a network of fully owned affiliates. It is the biggest Italian company in the IVD market with approximately 800 employees. Menarini Diagnostics has always operated in different sectors of IVD market and over the years it has acquired strong competences especially in the cell pathology and oncology market. Today it is one of the main European players in the “solid biopsy” field with immunohistochemistry and histology systems and is now entering the “liquid biopsy” field with the highly innovative CELLSEARCH and DEPArray technologies.

For more information see www.menarinidiagnostics.com, www.siliconbiosystems.com and follow on Twitter@SiliconBio.