Plasma based non invasive prenatal testing (NIPT) by Next Generation Sequencing (NGS) is being adopted into clinical laboratories.
However, obtaining sufficient amounts of patient derived reference materials for proficiency testing, assay validations, and daily quality checks remains difficult. We developed a technology that amplifies and stabilizes NIPT reference materials derived from circulating cell free DNA (ccfDNA) from pregnant donors. Amplification of ccfDNA from maternal sources allows reference materials to be created that are fetal maternal matched and maintain fetal maternal ccfDNA size distribution. These characteristics signify that the material is compatible with a wide variety of NIPT assays while amplification allows enough material to be made for commercialization.
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