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  • Non-invasive prenatal testing (NIPT) analyses cell-free DNA in a pregnant woman�s blood to estimate the risk of foetal chromosomal abnormalities.

      Panorama�s unique Single Nucleotide Polymorphism (SNP)-based technology enables more comprehensive screening with greater accuracy in validation.

    Only Panorama distinguishes between maternal and foetal (placental) DNA

    Panorama has validated performance in both high and average risk pregnancies

    * PPV = positive predictive value. ** For the purposes of calculating PPV, high risk was defined as women  35 years old at delivery, and average risk was defined as women < 35 years old at delivery.

    Screens for:

    Singleton pregnancies  Trisomies 21, 18, 13  Monosomy X  Triploidy  Sex chromosome trisomies*  22q11.2 deletion syndrome (optional)  Additional microdeletion syndromes

    (optional)  Foetal sex (optional)

    Twin pregnancies  Zygosity  Trisomies 21, 18, 13  Foetal sex for each twin (optional)

    If screening reveals monozygotic twins, Panorama can additionally screen for:  Monosomy X  Sex chromosome trisomies*  22q11.2 deletion syndrome (optional)

    Egg donor or surrogate pregnancies  (Singleton pregnancies only)  Trisomies 21, 18, 13  Foetal sex (optional)

    *Reported when suspected

    Panorama: the next generation of NIPT

    Support every step of the way

    � You can offer Panorama as early as 9 weeks gestation.

    � Appropriate for singleton, twin, egg donor and surrogate pregnancies.

    � Patient can visit any Lancet Laboratories depot in South Africa.

    � Booking may be required.

    � For a comprehensive location listing please visit www.lancet.co.za/ locate-a-lab/

    � Panorama utilises SNP-based sequencing and Natera�s proprietary algorithms to deliver highly accurate and comprehensive results.

    � Results will be available within 7 � 10 working days.

    � Reports include risk score, PPV (if high risk) and foetal fraction to give you confidence in the results and the care plan for your patient.

    SEAMLESS INTEGRATION Into your workflow

    SAFE, EASY Sample collection

    ADVANCED TECHNOLOGY For results you can trust

    FAST, CLEAR REPORTING With support from our team

    Ordering Information Please contact us for more information, including how to order the Panorama Prenatal Screen. Contact us on 086 163 3337 (Operating Hours: Mon - Fri 08H00-17h00.) Or email at [email protected] For Genetic Counselling (pre/post), please contact Dr Karen Milstein, Clinical Geneticist at 086 152 6238 or email: [email protected]

    References: 1. Pergament et al. Single-nucleotide polymorphism-based noninvasive prenatal screening in a high-risk and low risk cohort. Obstet Gynecol. 2014 Aug;124(2 Pt 1):210-8. doi: 10.1097/AOG.0000000000000363. 2. Dar et al. Clinical experience and follow-up with large scale single-nucleotide polymorphism based noninvasive prenatal aneuploidy testing. Am J Ob & Gyn 2014; 211(5):527e1-527 e17. 3. Norton et al. Cell-free DNA Analysis for Noninvasive Examination of Trisomy. N Engl J Med 2015; 372:1589-1597. 4. Nicolaides et al. Validation of targeted sequencing of single-nucleotide polymorphisms for non-invasive prenatal detection of aneuploidy of chromosomes 13, 18, 21, X, and Y. Prenat Diagn. 2013;33(6):575-9. doi: 10.1002/ pd.4103. 5. Ryan et al. Validation of an enhanced version of a single-nucleotide polymorphism-based noninvasive prenatal test for detection of fetal aneuploidies. Fetal Diagn Ther. 2016;40(3):219-223. 6. Martin et al. Clinical experience with a single-nucleotide polymorphism-based non-invasive prenatal test for five clinically significant microdeletions. Clin Genet. 2018; 93(2):293-300. 7. Ravi et al. Validation of a SNP-based non-invasive prenatal test to detect the fetal 22q11.2 deletion in maternal plasma samples. PLoS One. 2018 Feb 23;13(2):e0193476. doi: 10.1371/journal.pone.0193476. 8. Wapner et al. Expanding the scope of noninvasive prenatal testing: detection of fetal microdeletion syndromes. Am J Obstet Gynecol 2015; 212(3): 332.e1-9. 9. ACOG and SMFM Joint Committee Opinion: Cell-Free DNA Screening for Fetal Aneuploidy, Number 640, Sept 2015. 10. Gregg et al. ACMG statement on noninvasive prenatal screening for fetal aneuploidy. Genet in Med May 2013; 15(5). 11. Curnow et al. Detection of triploid, molar, and vanishing twin pregnancies by a single-nucleotide polymorphism based noninvasive prenatal test. Am J Obstet Gynecol 2015; 212(1): 79.e1-79.e9. 12. Futch et al. Initial clinical laboratory experience in noninvasive prenatal testing for fetal aneuploidy from maternal plasma DNA samples. Prenat Diagn 2013;33:569-74. 13. Wang et al. Maternal mosaicism is a significant contributor to discordant sex chromosomal aneuploidies associated with noninvasive prenatal testing. Clin Chem 2014; 60(1):251-9. 14. Simon et al. Detection of a complete molar pregnancy by single nucleotide polymorphism-based noninvasive prenatal testing. Ultrasound Obstet Gynecol 2015; 46(4):506-7. 15. Nicolaides et al. Prenatal detection of fetal triploidy from cell-free DNA testing in maternal blood. Fetal Diagn Ther. 2014;35(3):212-7. doi: 10.1159/000355655. 16. Wright et al. A unified approach to risk assessment for fetal aneuploidies. Ultrasound Obstet Gynecol 2015; 45: 48� 54.doi: 10.1002/uog.14694 17. Canick et al.The impact of maternal plasma DNA fetal fraction on next generation sequencing tests for common foetal aneuploidies.Prenat Diagn. 2013 Jul;33(7):667-74. doi: 10.1002/pd.4126.

    Disclaimer: This test was developed by Natera, Inc., a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). Natera and Panorama are trademarks of Natera Inc. used with permission.

    The next generation of non-invasive prenatal screening

    High Risk**

    Sensitivity

    Validation 1T21, T18, T13 and MX

    Clinical Outcomes 2T21, T18, T13 and MX

    Average Risk**

    Specificity PPV*(Aneuploidy Incidence)

    98.0% (98/100)

    99.5% (389/391)

    82.9% (2.4%)

    > 99% (5/5)

    100% (469/469)

    87.2% (1.0%)

    design done and printed by: ELECTRONIC LABORATORY SERVICES (PTY) LTD PRINT BUREAU

    corporate branding/brochures/sa/2018/B00055 physician fact sheet 630mmx297mm eng duplex labelnet jun2018.cdr | rev000

    ITEM CODE: B00055

  • Panorama targets single nucleotide polymorphisms (SNPs) in cell-free DNA (cfDNA)

    Measuring foetal fraction is critical for high confidence NIPT results Counting methodologies' ability to detect abnormalities decreases below 8% foetal fraction, which may

    16,17increase false negative results.

    Notes: * Representative comparison between expected and observed for a single chromosome.  Fraction of cfDNA that is foetal is a key component, with trisomy becoming easier to detect at higher foetal fractions.

    12  Excess maternal DNA could lower the sensitivity of the test.

    Disomy 21

    Trisomy 21

    Counting methods rely on the expected vs observed amount of DNA from the chromosome of interest. At lower foetal fractions, it is more challenging to see the difference between the usual two copies and the presence of a trisomy.

    Compared to First Trimester Screening, Panorama has higher sensitivity and lower false positive rates for the conditions screened.

    Highly accurate and comprehensive screening

    PPV: 91%* With NIPT, women will undergo invasive 10

    2testing to discover true positives.9

    * Specific to Trisomy 21

    A superior first-line screening test for all women

    PPV: 3 - 4% Maternal serum screening

    would require women to undergo 265 invasive testing to discover 9

    9true positives.

    Higher positive predictive value (PPV) = Less anxiety for patients

    TRADITIONAL SCREENING NON-INVASIVE PRENATAL TESTING (NIPT)

    Condition

    Trisomy 21 Down Syndrome

    79% 5%

    Trisomy 18 Edwards Syndrome

    80% 0.3%

    Trisomy 13 Patau Syndrome

    50% 0.3%

    1,4,5,6,7,8,15Panorama3First Trim. Screen

    Sensitivity False Positive Rate

    Sensitivity False Negative Rate

    Monosomy X Turner Syndrome Does not screen

    Triploidy Does not screen

    Female

    Optional Microdeletion Syndromes

    Does not screen

    Male Does not screen

    > 99% < 0.1%

    98.2% < 0.1%

    > 99% < 0.1%

    94.7% < 0.1%

    > 99%

    > 99.9% < 0.1%

    > 99.9% < 0.1%

    22q11.2 deletion DiGeorge syndrome

    Additional microdeletions (Angelman, Cri-du-chat, 1p36

    deletion & Prader-Willi)

    Does not screen

    Does not screen

    90.0% 0.07%

    93.8 - > 99% 0.07%

    9Discussing NIPT with your patients, per ACOG guidelines

    * Compared to serum screening

    Panorama�s advantages, when compared to traditional maternal serum screening

    Non-invasive method with more informative results

    �Testing for chromosome abnormalities is optional.�

    �If you would like to know the risk of your baby having a chromosome abnormality,

    screening options are available.�

    �If you want to know for sure about chromosome

    abnormalities you can opt for diagnostic testing.�

    Least Information

    B en

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