Natera, Inc. announced earlier at the Canaccord Genuity 42nd Annual Growth Conference in Boston that the company has proactively filed a pre-submission to the FDA for its Panorama® non-invasive prenatal test (NIPT) as part of the Q-Sub process. The company filed its pre-submission in June 2022 for fetal chromosomal aneuploidies and for 22q11.2 deletion syndrome. The pre-submission to the FDA follows the publication of results earlier this year from the SNP-based Microdeletion and Aneuploidy Registry Trial (SMART), the largest prospective NIPT study with confirmation of genetic outcomes, with more than 20,000 patients enrolled at 21 global medical centers.

In addition to SMART, Natera has a significant body of evidence supporting the performance of its Panorama test, including 26 peer-reviewed papers, studying over 1.3 million patients.