The collaboration will combine Silicon Biosystems' DEPArray digital-sorting technology with Macrogen's high-throughput next generation sequencing capabilities in order to develop tests certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 by the Centers for Medicare & Medicaid Services (CMS) of the US.
The certification, which is applicable to all clinical lab-testing performed on humans, helps ensure accuracy, reliability, and timeliness of test results.
Silicon Biosystems demonstrated the benefits of its DEPArray digital sorting toward obtaining “100% pure tumor and stromal cells for genetic profiling of FFPE tumor samples,” in the February 2016 edition of Scientific Reports, according to the company’s president and CEO Giuseppe Giorgini.
"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,” he added. “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."
According to Jeong-Sun Seo, M.D., Ph.D., chairman of Macrogen, precision medicine based on advanced genomic and oncological technology has been the company’s goal since its inspection.
“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," he said.
Macrogen is currently running two systems of HiSeq X Ten, providing whole-genome sequencing services worldwide. Under the collaboration, the company may also provide technical support for the somatic variant analysis of cancer cells by using its NGS expertise, as well as its clinical research capabilities.