Advancing prenatal testing requires an adequate supply of reference materials with clinical and genetic diversity. Using patient remnant samples for assay controls is not a viable or scalable option. Development of assays and routine testing for trisomies and microdeletions requires highly characterized reference materials to ensure the quality of testing.
This poster from SeraCare describes the development and clinical performance of reference materials for prenatal and preimplantation testing that appear suitable for a range of currently available PGT-A and NIPT methods. The reference material methodology can be applied to emerging genetic testing methodologies designed for rare disease testing.
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