Panorama AI See more with - The most widely used NIPT is now powered by Artificial Intelligence - Innermost Healthcare
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The only SNP-based NIPT delivers The #1 NIPT is now powered more insights and greater accuracy by Artificial Intelligence Panorama’s single nucleotide polymorphism (SNP)–based non-invasive prenatal test (NIPT) is: Panorama AI leverages artificial intelligence (AI) to learn from the more than • A rigorously validated NIPT 2 million tests already processed by Natera. • The only NIPT that distinguishes mother’s DNA from baby’s DNA for aneuploidies • The approach that creates unique, clinically validated capabilities Panorama AI combines AI with Natera’s proprietary SNP-based methodology to improve result-calling on difficult-to-call cases. • Maintaining industry-leading accuracy while significantly lowering “no-call” rates • Increasing accuracy for 22q11.2 deletion detection1 Highest #1 for a reason13 clinical PPVs TESTS across all age Lowest false negative rate groups Highest fetal sex accuracy 2M+ performed D CY AN RELIAB URA ILI C TY AC Mother PATIENTS 1.3M+ Adverse pregnancy Panorama T Zygosity G A outcome risk T G detection EVERY RES Advantages C studied T A TIO N assessment C UNIQUE CLINICAL NTI SNP VALUE1–27 SNP TARGETS UL RE 13,392 Vanishing T FE M TT IF twin and A Individual D ER S IN T triploidy S G TW fetal sex A T G detection G T C Baby PUBLICATIONS Maternal X Fetal 23+ mosaicism fraction of detection each twin SNPs Panorama evaluates SNPs— the 1% of our DNA that makes us different from one another.
Panorama AI was validated in SMART, “No-calls” provide actionable information the largest prospective NIPT study 1,5,6 SMART showed that, for Panorama, patients with “no-call” results after redraw have significantly higher rates of adverse outcomes—compared to baseline or patients with a call after redraw.6 CLINICAL UTILITY OF “NO-CALLS” Adverse pregnancy outcome rates for Panorama (prior version) Panorama AI further enriches this 16.5% high-risk group, making the “no-call” 14.8% after redraw group highly actionable.6,13 Consider the following for this group: 9.6% • Increased surveillance for pre-term SNP-based Microdeletion 8.3% labor and preeclampsia and Aneuploidy RegisTry PATIENTS SITES OUTCOMES 3.9% 2.9% 20,000+ 21 ~90% 2.0% 0.3% 0.3% “Patients with failed cfDNA should have follow-up surveillance.” global centers IUFD*/Stillbirth/SAB* PTB* 99.9% 83% 53% ACTIONABLE PERFORMANCE Panorama AI has increased sensitivity and 0.00% Sensitivity5 Sensitivity5 PPV5 0.00% 2.00% 4.00% After 1st draw After redraw >2X the positive predictive value (PPV) for “No-call” rate Panorama (prior version) Panorama AI Full A–D deletion Full & nested 22q11.2 deletions, enhancing the impact of (2.5 Mb+) deletions (0.5 Mb+) this screen, given the number of prenatal/ neonatal interventions for this disorder.5 *Most other studies of this kind rely on observational assessment, not genetic diagnostic testing. *IUFD=intrauterine fetal demise; SAB=spontaneous abortion; PTB=pre-term birth
Panorama maintains industry-leading Every pregnancy deserves Panorama performance and clinical value in singleton pregnancies “...[NIPT is] the most sensitive and specific screening test for the common aneuploidies...should be discussed and offered to all patients regardless of maternal age or baseline risk.”30 ACOG PRACTICE BULLETIN 226 Combined FNR in validation studies (T21, T18, T13) Fetal sex error rate in validation studies Panorama ACOG guidelines highlights, including unique capabilities of SNP-based NIPT Natera1–4 0.87% Zero errors (n = 1,309) Panorama's areas of unique Array-NIPT14–16 1.33% 1 in 748 (n = 748) ACOG PRACTICE BULLETIN 226 HIGHLIGHTS30 PANORAMA SNP-BASED COUNTING- BASED NIPT clinical value NIPT1-4,7-12 METHODS14,15,18-20,23-25 WGS1-NIPT18–21 1.89% 1 in 169 (n = 3,733) “Cell-free DNA [NIPT] can be performed in WGS2-NIPT23-26 2.4% 1 in 77 (n = 508) twin pregnancies” Other WGS-NIPTs No published validation data No published validation data “...one laboratory method which uses SNP analysis Twins reports zygosity as well as individual fetal fractions.” differentiation “[In twin gestations,] it is possible that an aneuploid fetus would contribute less fetal DNA, therefore masking the aneuploid result.” Panorama provides unique information Highlights known sources of false positives for most NIPTs: • Vanishing twin • Maternal mosaicism Addressed Not addressed Every result to appropriately triage high-risk “Of the [NIPT] methods, the [SNP-based] method can identify triploidy.” matters twin pregnancies “...the lower prevalence of fetal trisomies in younger patients results in...a lower PPV...” Robust clinical PPVs published Analytical PPVs available Accuracy and reliability Zygosity is key in appropriately managing twin pregnancies and monitoring for such conditions Trisomy 21 PPVs by age groups, shown in a large, 1M patient outcomes study12,13,31,32 Only Panorama NIPT can detect zygosity Trisomy 21 PPVs by age groups as twin-twin transfusion syndrome (TTTS): 95.0 97.6 ZERO 90.6 92.7 • One-fifth of monochorionic twins are misidentified PPVs by ultrasound.28 errors in Strong clinical evidence • One-sixth of misidentified cases that are referred zygosity detection7* with robust PPVs, to fetoscopic centers reach stage IV TTTS, and regardless of age. one-fifth suffer fetal/neonatal demise.29 Only Panorama reports individual fetal fractions** According to ACOG and SMFM, divergent fetal fraction in dizygotic twins can make it difficult to 7% detect aneuploidy in a twin with low fetal fraction of dizygotic twins h ave highly
Tailored Resources to support you and your patients Education Ordering Results Pre- and post- Patient-friendly materials Flexible options based Clear, actionable reports, test genetic and information sessions, around your needs. served with a side of information covering basic genetics For more information expert guidance sessions to specific tests contact your local Natera Regional Manager Access to board-certified genetic counselors, available to all providers and patients Panorama screens for: Singleton Twin If screening Egg-donor pregnancies pregnancies reveals or surrogate • Trisomies 21, 18, 13 • Zygosity monozygotic pregnancies • Monosomy X • Trisomies 21, 18, 13 twins, Panorama (singleton • Triploidy can additionally pregnancies • Fetal sex for each twin • Sex chromosome (optional) screen for: only) trisomies* • Monosomy X • Trisomies 21, 18, 13 • 22q11.2 deletion • Sex chromosome • Fetal sex (optional) syndrome (optional) trisomies* • Additional • 22q11.2 deletion microdeletion syndrome (optional) syndromes (optional) • Fetal sex (optional) References 1. Dar et al. Multicenter prospective study of SNP-based cfDNA 10. McKanna T et al. Ultrasound Obstet Gynecol. 2019;53(1): 24. Bianchi et al. Obstet Gynecol. 2012 May; 119(5):890-901 screening for aneuploidy with genetic confirmation in 18,497 73–79 25. Bianchi et al. N Engl J Med. 2014;370:799-808 pregnancies. Society of Maternal-Fetal Medicine, SMFM. 11. Martin KA et al. Am J Obstet Gynecol. MFM 2020;2:100152 26. Verinata white paper. Analytical validation of the Verifi Virtual Meeting. Oral Presentation. Jan 25-30, 2021 12. DiNonno W. et al. J Clin Med. 2019 Aug; 8,1311 prenatal test. 2012 2. Pergament et al. Obstet Gynecol. 2014 Aug; 124(2 Pt 1):210-8 13. Natera internal data on file 27. Commercial protocol not validated; Illumina marketing 3. Nicolaides et al. Prenat Diagn. 2013 June; 33(6):575-9 14. Stokowski et al. Prenat Diagn. 2015 Dec; 35(12):1243-6 materials cite “Srinivasan et al. Am J Hum Genet. 2013 Feb 7; 4. Ryan et al. Fetal Diagn Ther. 2016;40(3):219-223 15. Jones et al. Ultrasound Obstet Gynecol. 2018 Feb;51(2): 92(2): 167–176” which does not match number of reads used 5. Dar et al. Multicenter prospective study of SNP-based 275-276 in commercial testing cfDNA for 22q11.2 deletion in 18,290 pregnancies with genetic 16. Hooks et al. Prenat Diagn. 2014;34(5):496-499 28. Blumenfeld et al. J Ultrasound Med. 2014 Dec;33(12):2187-92 confirmation. Society of Maternal-Fetal Medicine, SMFM. 17. Schmid et al. Fetal Diagn Ther. 2017, DOI: 29. Baud et al. Ultrasound Obstet Gynecol. 2014; 44: 205–209 Virtual Meeting. Oral Presentation. Jan 25-30, 2021 10.1159/000484317 30. ACOG Practice Bulletin 226. Obstet Gynecol. 2020 6. Norton et al. Perinatal and genetic outcomes associated with 18. Palomaki et al. Genet Med. 2011 Nov; 13(11):913-20 Oct;136(4):859-867. no call cfDNA results in 18,497 pregnancies. Society 19. Palomaki et al. Genet Med. 2012 Mar; 14(3):296-305 31. Myriad Women’s Health website accessed Oct 23 2019 of Maternal-Fetal Medicine, SMFM. Virtual Meeting. Oral 20. Porreco et al. Am J Obstet Gynecol. 2014;211:365.e1-12 32. Progenity Innatal Clinician Guide. Presentation. Jan 25-30, 2021 21. Mazloom et. al. Prenat Diagn. 2013 Jun;33(6):591-7 7. Norwitz et al. J Clin Med. 2019 Jun; 8:937 22. Tynan et al. Society for Maternal-Fetal Medicine, SMFM. 8. Hedriana H et al. Prenat Diagn. 2020 Jan;40(2):179-184 Las Vegas, Nevada. Jan 23-28, 2017 9. Nicolaides et al. Fetal Diagn Ther. 2014;35(3):212-7 23. Sehnert et al. Clin Chem. 2011 Jun;57(7):1042–1049 201 Industrial Road, Suite 410 | San Carlos, CA 94070 | 1.650.249.9090 | Fax 1.650.730.2272 | www.natera.com The tests described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA is exercising enforcement discretion of premarket review and other regulations for laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. Panorama TM is a non-invasive prenatal test (NIPT) based on cell-free DNA analysis and is considered a prenatal screening test, not a diagnostic test. Before making any treatment decisions, all women should discuss their results with their healthcare provider, who can recommend confirmatory, diagnostic testing where appropriate. PAN_MD_BR_PanoramaAI_INTL_20200208_NAT-8020396 *Reported when suspected
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