Research Adds to Growing Evidence of Clinical Utility of CTCs for the management of Metastatic Breast Cancer Patients

Bologna, Italy and Huntingdon Valley, Pa., NOVEMBER 29, 2018 -- Menarini Silicon Biosystems announced today that new data utilizing the company’s CELLSEARCH® Circulating Tumor Cell Test will be presented at the upcoming 2018 San Antonio Breast Cancer Symposium (SABCS).

A total of 21 studies will be presented: 20 posters and an oral communication reporting results of a large French multicenter phase 3 trial (STIC CTC trial) investigating the clinical utility of circulating tumor cells (CTCs) in the management of hormone receptor-positive metastatic breast cancer patients.

"Physicians have been using CELLSEARCH in their clinics since it was first cleared by the FDA in 2004, and the number of studies presented during the conference underscores the longstanding value of CTCs,” said Bob Roda, President and CEO of Menarini Silicon Biosystems Inc., makers of the CELLSEARCH System. “Furthermore, the STIC CTC trial results represent the first valuable step toward clinical utility demonstration, and we look forward to the continued involvement of our technology in additional prospective trials.”

Oral Presentation details:

Thursday, December 6 - General Session 3

Title: Clinical utility of circulating tumor cell count as a tool to choose between first line hormone therapy and chemotherapy for ER+ HER2- metastatic breast cancer: Results of the phase III STIC CTC trial

Authors: Francois-Clement Bidard, William Jacot, Sylvain Dureau, E. Brain, T. Bachelot, H. Bourgeois, A. Goncalves, S. Ladoire, H. Naman, F. Dalenc, Joseph Gligorov, Marc Espie, Christelle Levy, Jean-Marc Ferrero, Doriane Loirat, Paul H. Cottu, Veronique Dieras, Cecile Simondi, Berger Frederique, Catherine Alix-Panabieres, Jean-Yves Pierga

Program #: GS3-07, Abstract: 1097
Location: Hall 3, Time: 11:00-11:15 a.m.

CTCs are cancer cells that are released and disseminated into the bloodstream and lymphatic system by advanced cancers. A liquid biopsy uses a sample of blood to detect circulating tumor markers (i.e. CTCs, ctDNA or exosomes) and provides a minimally invasive alternative to a solid tumor biopsy — especially when suspected cancer tissue is not accessible.

CELLSEARCH is the first and only clinically validated blood test cleared by the FDA for detecting and enumerating circulating tumor cells (CTCs) as an aid for physicians to manage patients with metastatic breast, prostate and colorectal cancers. The test is also approved by the National Medical Products Administration (NMPA) for use as an aid in monitoring metastatic breast cancer patients.

The CELLSEARCH System is the most extensively studied CTC technology, with research published in more than 450 peer-reviewed publications. To date, clinical data from 28 independent prospective studies involving more than 4,700 patients have validated the clinical value of CELLSEARCH CTC testing to predict progression-free survival and overall survival both before and after therapy initiation.

Providing valuable information to help physicians make a patient management decision, the CELLSEARCH CTC test is performed at a reference laboratory using the CELLSEARCH 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 learn more about the CELLSEARCH System, SABCS attendees can visit Menarini Silicon Biosystems at Booth #413. For more information on the full intended use and limitations of CELLSEARCH System, please refer to the Instructions for Use on http://documents.cellsearchctc.com/.

SABCS will be held at the Henry B. Gonzalez Convention Center, San Antonio, Texas, Dec. 4-8, 2018.

About Menarini Silicon Biosystems
Menarini Silicon Biosystems, based in Bologna, Italy, and Huntingdon Valley (PA), USA, develops technologies and products that help researchers understand the biological complexity of disease through the study of single cells. The company manufactures and markets the DEPArray NxT, the only image-based digital cell-sorting and isolation platform that enables clinical researchers to conduct molecular analyses on live or fixed cells with single-cell precision. In 2017 Menarini Silicon Biosystems purchased all the assets and relevant business related to the CELLSEARCH® Circulating Tumor Cell (CTC) System. The integration of CELLSEARCH and DEPArray provides an end-to-end workflow solution* for the enumeration, isolation, and molecular characterization of CTCs from a simple blood test in the clinical research setting. This will help drive the clinical utility and correlation of CTCs with the effectiveness of specific therapies. Menarini Silicon Biosystems is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics company headquartered in Florence, Italy, with a heritage of over 130 years and over 17,000 employees in more than 100 countries.

*The workflow described is for research use only. Not for use in diagnostic procedures. The performance characteristics and safety and effectiveness of the workflow have not been established and are not cleared or approved by the FDA.