CLIA

Under the deal, the partnership will combine Silicon Biosystems’ DEPArray digital-sorting technology with Macrogen’s next-generation sequencing capabilities 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 combination of Macrogen’s whole-genome, whole-exome and targeted sequencing capabilities with the DEPArray’s technology is expected to help resolve cellular heterogeneity of formalin-fixed paraffin-embedded (FFPE) biopsies and fine-needle aspiration (FNA) samples.

According to the company, the novel assays and procedures help to deliver pure cancer and tumor-negative control cells, as well as other key cellular elements such as tumor-infiltrating lymphocytes from FFPE tumor samples.

Silicon Biosystems president and CEO Giuseppe Giorgini said: "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."

Macrogen chairman Dr Jeong-Sun Seo said: "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 offers DNA sequencing, next generation sequencing, microarray analysis, oligonucleotide synthesis, DNA chip and genetically engineered mice services in around 120 countries.

Silicon Biosystems Menarini produces and markets DEPArray system, which allows researchers to automatically identify, quan¬tify and recover individual rare cells with single-cell precision.


Image: Silicon Biosystems and Macrogen to develop CLIA-certified genomic cancer assays. Photo: courtesy of Suwit Ritjaroon / FreeDigitalPhotos.net.