Northwestern Researchers Use Gold-Standard Liquid Biopsy Technology to Identify Potential New Biomarker

Bologna, Italy and Huntingdon Valley, Pa., MARCH 26, 2019 -- Menarini Silicon Biosystems, the pioneer of liquid biopsy technology, today announced that significant advances in research using the company’s CELLSEARCH^® and DEPArray^TM technologies will be presented at the upcoming annual meeting of the American Association for Cancer Research (AACR).

One presentation will cover research from Northwestern University that used the FDA-cleared CELLSEARCH Circulating Tumor Cell (CTC) Test to conduct CTC testing on metastatic breast cancer (MBC) patients.* The study was co-authored by Massimo Cristofanilli, M.D., F.A.C.P., Associate Director of Translational Research at Robert H. Lurie Cancer Center, Northwestern University. It will report on a significant correlation between high levels of co-expression of CCR5 and HER2 in CTCs. CCR5 has been associated with cancer stem cells and believed to drive metastatic process. The researchers suggest that CCR5 may contribute to more aggressive phenotype by upregulating HER2 expression. It is the first evidence of identifying CCR5 expression in CTCs as a potential new marker for MBC with potential therapeutic implications.

“This is an exciting study, as it provides evidence of CCR5 being a potential therapeutic target for breast cancer,” said Dr. Cristofanilli. “This observation is the basis of an upcoming clinical trial incorporating detection CCR5/CTC expression and in which we will target CCR5 with a specific antibody in the hopes of preventing metastasis and prolong disease control in patients with TNBC.”  

In addition, the Northwestern researchers will present a new application of the CELLSEARCH and DEPArray^TM NxT systems for the isolation of CTC clusters in MBC.** CTC-clusters are reported to have greater potential to form distant metastasis compared to individual CTCs. The novel Research Use Only workflow helps streamline the isolation of both single CTCs and CTC-clusters to facilitate genomic analysis for MBC patients.

“Our goal at Menarini Silicon Biosystems continues to be the improvement of patient care through innovative single-cell precision medicine technologies and solutions that provide actionable information for clinicians and researchers,” said Bob Roda, Chief Executive Officer of Menarini Silicon Biosystems. “Our expanding portfolio of technologies and solutions is helping researchers better understand cancers at the molecular level.”  

A study involving a collaboration between Menarini Silicon Biosystem researchers and scientists from Fraunhofer ITEM Regensburg will present a new application using the company’s DEPArray technology for marker-dependent single-cell isolation from malignant melanoma lymph nodes.

Another study will demonstrate a new approach to understanding tumor heterogeneity in classic Hodgkin lymphoma (cHL), starting from formalin-fixed paraffin-embedded (FFPE) samples and enabling cHL genome-wide genetic analysis at the single-cell level. In the future, these approaches could be used to help select individualized therapies for patients with these cancers.

Menarini Silicon Biosystems will also be introducing two new products for research use only: Ampli1™ OncoSeek, a targeted cancer panel, and MSBiosuite, a cloud-based bioinformatics platform.

Ampli1 OncoSeek is a panel that offers a targeted next-generation sequencing (NGS) assay comprised of 60 clinically-relevant oncology genes, which facilitates NGS library preparation from single cells isolated with the DEPArray technology.

MSBiosuite is a fully-automated, secure platform that enables customers without bioinformatics capabilities to easily analyze and interpret the NGS data generated by the DEPArray and Ampli1 molecular analysis kits. It provides a complete end-to-end solution for laboratory workflow from sample input through to processed results, including genetic interpretation for research use only, not for diagnostics purposes.

These products will be featured in a study that presents a complete solution to detect hotspot mutations and focal copy number alterations (CNA) that are needed for accurate tumor characterization. This targeted sequencing workflow is suitable for analyzing CTCs at a single-cell level, which assists researchers with understanding tumor heterogeneity.

To learn more about the Menarini Silicon Biosystems technologies, AACR attendees can visit Booth #2702. The AACR Annual Meeting will take place March 29-April 3, 2019 in Atlanta, Georgia.

About Menarini Silicon Biosystems

Menarini Silicon Biosystems, based in Bologna, Italy, and Huntingdon Valley (PA), USA, develops innovative 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^TM 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.

*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/.

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