Proven performance in a
prenatal screen

Innatal noninvasive prenatal screening is backed by a peer-reviewed, high powered study.

We upgraded the Innatal® Prenatal screen in October 2018 with the latest sequencing technology and improved chemistry.

Data supporting top performance in this upgraded test was then published in the Journal of Medical Screening.1 Verification and validation of this test were conducted as prescribed by multiple peer-reviewed guidelines.2,3,4 This clinical study was blinded and adjudicated by a third party.

What did we find?

  • Innatal is a cfDNA prenatal screen you can trust.
  • Precise – Agreement of >99% for repeatability and reproducibility
  • Accurate – High concordance with known clinical outcomes
  • Sensitive – Proven to identify affected fetuses with >99% sensitivity
  • Specific – Proven to rule-out unaffected fetuses with >99% specificity
  • Limited failure – Clear answers the first time with a low failure rate (~1%)
Validation data was published in the Journal of Medical Screening (Sep. 2019). Read the manuscript
A summary of our verification and validation results. Download the data summary sheet

References

  1. Porreco et al. Evaluation of a novel screening method for fetal aneuploidy using cell-free DNA in maternal plasma. J Med Screen. 2019 Sep 11; [Epub ahead of print].
  2. Jennings et al. Recommended principles and practices for validating clinical molecular pathology tests. Arch Pathol Lab Med. 2009;133(5):743-55.
  3. Lacbawan et al. Verification of performance specifications of a molecular test: cystic fibrosis carrier testing using the Luminex liquid bead array. Arch Pathol Lab Med. 2012;136(1):14-9.
  4. Rehm et al. ACMG clinical laboratory standards for next-generation sequencing. Genet Med. 2013;15(9):733-47.