PGT-SR approved by NJ Department of Health

February 2019 Marks the approval of Genomic Prediction's PGT-SR (Preimplantation Genetic Test for Structural Rearrangement) testing, in addition to PGT-A, PGT-M, and PGT-P, meeting the IVF medical standards of the DOH. Our test is the only one in the world with this capability.

Genomic Prediction, Inc., a world leader in advanced methods for the genotyping of the human embryo, announces that the New Jersey Department of Health Clinical Laboratory Improvement Services have Approved Genomic Prediction's license to apply our test to human samples, after "blind sample" validation in accord with the industrial scientific principles and IVF medical standards of the New Jersey DOH, and a validation performed on a human cohort diagnosed with clinical Hypothyroidism, and a human cohort diagnosed with the monogenic disorder of Cystic Fibrosis, and human aneuploid cohort.

Genomic Prediction has pioneered a novel methodology for preimplantation genetic testing, utilizing proprietary methods for the genetic testing of the human embryo. The validation of the capability of this test to genotype human samples for both clinical aneuploidy, monogenic disorders, polygenic disorders, and now structural rearrangement (also known as chromosomal PGD) is critical to application in a clinical setting. This successful validation was required for the method to be properly licensed by the Department of Health.

This "proficiency testing" validation is in addition to and in parallel with Genomic Prediction's own embryo biopsy validation dataset and validation whitepaper for our gSEQ kit, and in addition to our many research papers on the competence of genomic prediction's models in human adults.

© Genomic Prediction, 2019