Silicon Biosys­tems Menarini, Macrogen to jointly develop genomic cancer tests

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 a 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.