The Panorama® non-invasive prenatal test (NIPT) has been pre-submitted to the FDA as part of the Q-Sub process, Natera, Inc., a leader in cell-free DNA testing, announced earlier today at the Canaccord Genuity 42nd Annual Growth Conference in Boston. In June 2022, the business submitted their pre-submission for 22q11.2 deletion syndrome and foetal chromosomal aneuploidies.
“NIPT has become the standard of care for prenatal screening”, “We have a track record of proactively engaging with the FDA and believe there are benefits to working with the Agency on this technology.”
Steve Chapman, CEO of Natera
The SNP-based Microdeletion and Aneuploidy Registry Trial (SMART), the biggest prospective NIPT research with confirmation of genetic outcomes, with more than 20,000 patients enrolled at 21 global medical facilities, published data earlier this year. This led to the pre-submission to the FDA. Along with SMART, Natera has a substantial amount of research to back up the effectiveness of its Panorama test, including 26 peer-reviewed articles looking at more than 1.3 million patients.
As early as nine weeks into a pregnancy, Panorama does screenings for severe genetic abnormalities. The test analyses fetal/placental DNA collected from a blood sample from the mother using a special single-nucleotide polymorphism (SNP)-based technique. To determine the likelihood of aneuploidies, it is the only commercially available test that distinguishes between maternal and foetal DNA. Since the debut of Panorama, Natera has published 26 articles that examine more than 1.3 million patients. Natera, the CLIA-certified laboratory conducting the test, has developed Panorama and determined its performance characteristics. US Food and Drug Administration clearance or approval for the test are not yet available (FDA). CLIA certification, ISO 13485 certification, and CAP accreditation.