Strategic Initiative

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Macrogen and Silicon Biosystems Menarini to Co-Develop CLIA-Certified Genomic Cancer Assays

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Additional Information

Additional Relevant Details 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.
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Strategic Initiative Date
Announcement Date:
Feb 12, 2016
Projected Implementation:
Q1, 2016
Relevance Tracked Until:
Q4, 2016
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Related Keywords Co-development, Clia-certified Genomic Cancer Assays, Deparray, Fnas, Low-cellularity Ffpe, Whole-genome, Whole-exome, Cancer And Tumor-negative Control Cells, Tumor-infiltrating Lymphocytes, Ffpe Tumor