Collaboration Aims to Integrate Digital Sorting with Next Generation Sequencing (NGS) of Formalin-Fixed Paraffin-Embedded Biopsies and Fine-Needle Aspiration Samples

SAN DIEGO, Calif., and SEOUL, South Korea, February 12, 2016 — Silicon Biosys­tems Menarini and Macrogen, Inc. today announced they will form a partnership to provide clinical assays and innovative procedures for precision medicine in cancer.

The goal of the collaboration is to combine Silicon Biosystems’ DEPArray™ digital-sorting technology with Macrogen’s high-throughput Next Generation Sequencing capabilities toward the development of tests certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 by the Centers for Medicare & Medicaid Services (CMS) of the United States. Applicable to all clinical lab-testing performed on humans, an objective of CLIA certification is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.

The partnership will combine Macrogen’s whole-genome, whole-exome, and targeted sequencing capabilities with the DEPArray’s power to resolve cellular heterogeneity of formalin-fixed paraffin embedded (FFPE) biopsies and fine-needle aspiration (FNA) samples, delivering 100% pure cancer and tumor-negative control cells, as well as other key cellular elements such as tumor-infiltrating lymphocytes from FFPE tumor samples.

“In the February 2016 edition of Scientific Reports (Nature), we demonstrated the super­ior benefits of DEPArray digital sorting toward obtaining 100% pure tumor and stromal cells for genetic profiling of FFPE tumor samples,” explained Giuseppe Giorgini, president and CEO of Silicon Biosystems. “Pure cells provide exact answers about all kinds of genomic variation and instability from the level of targeted cancer panels up to the whole genome level, making DEParray sorting and sequencing an unparalleled tool for precision patient stratification. Furthermore, through DEPArray sorting we can help rescue samples with very low number of tumor cells, like FNAs and low-cellularity FFPE. We believe that Macrogen, with its proven NGS expertise, is an ideal partner to make such benefits available to patients and pharmaceutical companies through combined services provided in a CLIA environment.”

Jeong-Sun Seo, M.D., Ph.D., chairman of Macrogen Inc. said, “Precision medicine based on advanced genomic and oncological technology has been Macrogen’s vision since its establishment. This collaboration between Macrogen and Silicon Biosystems Menarini for the development of tumor-cell specific cancer somatic variants analysis will bring the critical benefit of precision medicine to cancer patients in urgent need sooner than we expected.”

Macrogen is currently running two systems (20 instrument units) of HiSeq X Ten, providing whole-genome sequencing service worldwide. Macrogen also has a CLIA-certified laboratory, MCL, in Rockville, Maryland. Macrogen is expected to provide technical support for the somatic variant analysis of cancer cells by using its NGS expertise as well as clinical research capabilities.

About Macrogen

Macrogen, Inc., based in Seoul, Korea, is a world leading service provider in high-quality genetic analysis and has enjoyed stable and steady growth since 1997. Macrogen Inc. has been dedicated to providing a reliable and efficient service of DNA sequencing and bioinformatics with profound knowledge and unbeatable amount of experience over 17 years. The company's diverse offerings include DNA sequencing, next generation sequencing, microarray analysis, oligonucleotide synthesis, DNA chip and genetically engineered mice services. Macrogen serves over +17,000 customers from academic research and industry in 120 countries around the globe, and it has subsidiary companies in the U.S., Japan and Europe, headquartered in South Korea. Find out more at www.macrogen.com

About Silicon Biosystems Menarini

Silicon Biosystems Menarini, based in San Diego, Calif., and Bologna Italy, is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics company based in Florence, Italy, with a heritage of over 130 years and over 16,000 employees in more than 100 countries. The company manufactures and sells the DEPArray system, which enables researchers to automatically identify, quan­tify, and recover individual rare cells with single-cell precision.

See www.siliconbiosystems.com for more information.

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