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Menarini-Silicon Biosystems Completes Acquisition of Janssen CTC System

NEW YORK (GenomeWeb) – Bologna, Italy-based Menarini-Silicon Biosystems said today that it has completed the purchase of all assets and relevant business from Janssen Diagnostics related to the Cellsearch circulating tumor cell system.

Financial terms of the asset acquisition were not disclosed.

With the acquisition, Menarini-Silicon has entered the US diagnostics market and takes ownership of the Cellsearch circulating tumor test, which the firm said is the first and only clinically validated blood test cleared by the US Food and Drug Administration for detecting and enumerating circulating tumor cells.

The China Food and Drug Administration has approved the test for monitoring metastatic breast cancer patients.

Under the agreement with Janssen, Menarini-Silicon Biosystems will assume operations of Janssen's CLIA-certified laboratory in Huntingdon Valley, Pennsylvania, and it will lead business operations in the US and the rest of the world outside Europe. In Europe, A. Menarini Diagnostics will lead business operations. Both Menarini-Silicon and A. Menarini are wholly owned subsidiaries of European in vitro diagnostics firm The Menarini Group.

The test helps clinicians manage patients with metastatic breast, prostate, and colorectal cancers. It is performed at a reference laboratory and runs on 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 the prognosis is favorable, Menarini-Silicon said.

Menarini-Silicon noted that the acquisition supports its strategic objective of developing companion diagnostics that accelerate the validation of personalized therapies and the selection of patients more likely to respond to targeted drug treatment.

The current deal relates to business operations in the US and Europe. At a later stage, the firm expects to close a deal that relates to business operations in the rest of the world.

The Cellsearch product line product line includes the Celltracks Autoprep System, the Cellsearch Analyzer II, and the Cellsearch CTC kit. All will become part of the firm's growing advanced diagnostics portfolio, which includes its flagship DEPArray NxT research-use-only system. Its digital cell-sorting and isolation system, complemented by 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 firm said.

Menarini-Silicon's CEO Giuseppe Giorgini noted that integrating Cellsearch with DEPArray provides an end-to-end workflow solution for the enumeration, isolation, and molecular characterization of CTCs. "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," he added.

Integrating Cellsearch enrichment with DEPArray sorting has been shown to deliver 100 percent pure cells suitable for precise and reproducible downstream next-generation sequencing analysis, the firm said. DEPArray technology also has other applications that include recovery and molecular characterization of pure cell populations from disaggregated formalin-fixed paraffin-embedded specimens, fresh tissues, and fine-needle aspiration samples.

To date clinical data from 28 independent prospective studies involving more than 4,700 patients have validated the clinical performance and value of the Cellsearch CTC test in predicting progression-free survival and overall survival both before and after therapy initiation, the firm said.