Menarini Silicon Biosystems has signed an agreement for the acquisition of the CELLSEARCH CTC business from American company Janssen Diagnostics LLC. At the moment of closing, the ownership of the only system already cleared by the Food and Drug Administration and CE marked for detecting Circulating Tumor Cells (CTC) in cancer patients starting from a liquid biopsy, will pass into the hands of Menarini Silicon Biosystems

Menarini acquires CELLSEARCH business from American group Janssen Diagnostics, pioneer in high-tech cancer diagnostics

Florence, 20^th December 2016 – Menarini Silicon Biosystems shall also take over the management of the clinical research and manufacturing plant and the CLIA-certified laboratory located in Huntingdon Valley, Pennsylvania, near Philadelphia, dedicated to cancer diagnostics.
Thanks to this acquisition, Menarini strengthens its presence in the field of technology for the analysis of CTCs in blood. Menarini Silicon Biosystems’ DEPArray technology for the evaluation of liquid and solid biopsies and the isolation of CTCs will be combined with the global technology which allows such cells to be retrieved and enumerated. The combination of the two technologies, CELLSEARCH and DEPArray, represents today the gold standard in the field of liquid biopsy, allowing both a mapping of the genome and analysis of the mutations of the tumor cells of each individual patient from a simple blood sample,  as well as a more rigorous prognosis and evaluation of the risk of recurrence of the disease with an unprecedented degree of precision. The possibility to single out the most suitable therapies for each patient will become more certain and the monitoring of any possible resistance to treatment shall become easier.

Florence, December, 20^th 2016 – Menarini acquires the CELLSEARCH business, from American company Janssen Diagnostics LLC. The aim is to enhance the DEPArray technology, pride of Menarini Silicon Biosystems for cancer diagnosis and result of Italian research, making it faster and more effective.

CELLSEARCH extracts the circulating tumor cells from the blood sample through a method cleared by the FDA. Up to date, the process would stop at this stage and it would only be possible to ‘enumerate’ the cells but not analyze them. It’s right here that the Italian technology will be introduced by means of Menarini's DEPArray system, capable of singling out these cells, already identified as cancer cells, one by one, so that both the genome and the mutations may be analyzed without any contamination and the most suitable drug treatment for each patient may be found, a ‘tailor made’ therapy which is truly precise and personalized.

Lucia Aleotti and Alberto Giovanni Aleotti,
Chairman and Vice Chairman of Menarini Group,
announce the acquisition of CellSearch
with Giuseppe Giorgini
Chairman and CEO di Menarini Silicon Biosystems

"This acquisition is an important milestone for Menarini Silicon Biosystems, that can now count on a clinical research and manufacturing plant in the USA and shall enhance its know-how through the expertise of American scientists engaged in top level studies in the field of oncological diagnostics" explained Lucia and Alberto Giovanni Aleotti, Chairman and Vice Chairman of the Menarini Group. "There are approximately 300 labs using CELLSEARCH CTC for liquid biopsies in the world today. Now, by flanking this technology with Menarini’s DEPArray, these laboratories and many others will be able to move on from a mere prognosis of survival to an analysis of the cancer genome with an extraordinary leap forward in being able to choose the right treatment for each patient."

CELLSEARCH  CTC is the only instrument capable of “retrieving” and enumerating circulating tumor cells which has, up to date, been validated by the Food and Drug Administration and bears the CE mark for In Vitro Diagnostics, in the wake of more than 400 scientific publications which have proven its effectiveness. The method allows scientists to count with an extremely high degree of precision the number of tumor cells that “detach” from the tumor and are directly related to a greater risk of metastasis. These cells could contain all the information needed to understand the genetic mutations of the tumor and identify molecular targets for personalized therapies.

“The CELLSEARCH technology, thanks to specific tumor cell markers and the magnetic separation of the tumor cells from all the other blood cells, allows us to ‘sift’ and identify those cells that have ‘detached’ from the primary tumor: if there are more than five of these then the prognosis is negative and there is a higher risk of mortality”- explained Giuseppe Giorgini, Chairman and CEO of Menarini Silicon Biosystems. “Once the circulating tumor cells have been identified by CELLSEARCH, the DEPArray technology steps in to isolate them, one by one, affording an analysis in a pure state through the most advanced genetic methods. The resulting sample is 100% pure and the genomic analysis can offer the maximum of its potential, together with greater simplicity in interpreting the data. All this is possible starting from a simple blood sample and in circumstances in which there are few circulating tumor cells.”

“Being able to identify the mutations of the single cells of each patient means we can understand if and which drug, or combination of drugs, can be more effective and helpful in that specific case", highlighted Giorgini. “Thanks to this test the oncologist will be able to evaluate the risk for each patient and his/her ability to respond to the therapies available. In those cases in which no treatment is already marketed for tumors with the mutations identified, it will be possible to opt to enroll the patient in a clinical trial if the specialist believes that a drug undergoing development might prove effective against tumors with mutations of the type observed. The use of the CELLSEARCH CTC test has already been cleared for the monitoring of metastatic breast, prostate and colorectal cancers, and will most probably be introduced for other tumor types: the synergy coming from the combined use of CELLSEARCH CTC and DEPArray, will provide users with an amazing yet easy to use instrument for the diagnosis and personalization of therapies, so as to optimize their effect against the diseased cells. All this means that the course of the disease may be assessed over time and information crucial to an effective monitoring of the same may be collected in order to evaluate the onset of any resistance to the drugs", concluded Giorgini.