Natera’s test offerings are built upon a platform of cutting edge genetic science, advanced bioinformatics, and technical innovation. though laboratory-based diagnostics are a largely unregulated area, our philosophy is that all diagnostic tests that we offer undergo rigorous pre-clinical and/or clinical validation.
PreNATUS (Prenatal Non-invasive Aneuploidy Testing using SNPs)
This is a prospective blinded trial to validate clinical use of Parental SupportTM technology to detect genetic abnormalities (including down Syndrome) from free floating fetal DNA found in maternal blood during pregnancy. This study is sponsored by Natera with grant funding from the NIH, and is being lead by Chief Investigator Dr. Ronald Wapner at Columbia University Medical Center. Participating centers include:
Non-invasive Prenatal Diagnosis Validation
This is a retrospective trial to validate use of Parental Support technology to detect a broad group of chromosome abnormalities (including microdeletions) from free floating fetal DNA found in maternal blood during pregnancy. This study is actively recruiting patients that are carrying a fetus diagnosed with any chromosome abnormality by amniocentesis or CVS. Patients can participate by contacting Natera directly at info@natera.com.
IPSO (Impact of Parental Support on pregnancy Outcomes)
This is a prospective randomized controlled trial to determine whether aneuploidy PGD of embryos created during IVF improves pregnancy and implantation rates. The study is being conducted in collaboration with Ferring Pharmaceuticals and is partially supported by grant funding from the NIH. This study is actively recruiting patients. more information is available at clinicaltrials.gov.
First Use of Parental Support Technology for Single Gene Analysis Plus Aneuploidy Screening in Preimplantation Genetic Diagnosis
This is ongoing but no longer recruiting patients. The purpose of this study was to validate clinical use of Parental Support technology to detect specific genetic mutation(s) known to cause severe inheritable diseases in embryos produced by at-risk couples. This may be done while simultaneously testing these embryos for aneuploidy. This study was partially supported by grant funding from the NIH. more information is available at clinicaltrials.gov.
Phase II: Clinical Use of Parental Support to Detect Single Gene Mutations
This is ongoing but no longer recruiting patients. This study composed second phase validation of the Single Gene PGD study listed above. This study was partially supported by grant funding from the NIH. more information is available at clinicaltrials.gov.
Molecular Karyotyping of Products of Conception (POC) following Miscarriage
This study is complete. This was a prospective study conducted by Stanford University comparing molecular karyotyping using Parental Support technology with maternal cell contamination detection to traditional metaphase karyotype. Results were presented at the American Society of Reproductive Medicine meetings in 2010 and are currently submitted for publication.