Natera, Inc., a global leader in cell-free DNA testing, 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.
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“NIPT has become the standard of care for prenatal screening,” said Steve Chapman, CEO of Natera. “We have a track record of proactively engaging with the FDA and believe there are benefits to working with the Agency on this technology.”
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.
Panorama screens for severe genetic disorders as early as nine weeks into pregnancy. The test uses a unique single-nucleotide polymorphism (SNP)-based technology to analyze fetal/placental DNA obtained through a blood draw from the mother. It is the only commercially available test that differentiates between maternal and fetal DNA to assess the risk of aneuploidies. Natera has published 26 papers, studying over 1.3 million patients, since the launch of Panorama. Panorama has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California.