Gain early insights into your prenatal health with Prenactive Noninvasive Prenatal Screen

The Prenactive NIPS Advantage

Prenactive NIPS safely and noninvasively screens for the most common chromosomal conditions affecting pregnancies. This screen can be done as early as 10 weeks gestation using a single maternal blood draw and offers high detection rates, low false positive rates, and the lowest test failure rate in the industry.1

What is noninvasive prenatal screening?

Noninvasive prenatal screening (NIPS), often referred to as noninvasive prenatal testing (NIPT), is a screening that helps determine the risk of your child being born with specific genetic conditions.

During pregnancy, fragments of DNA from the placenta are released into the mother’s blood stream. Using NIPS, these DNA fragments are sequenced and an assessment is made to determine if there is an increased or decreased risk for certain chromosomal abnormalities in the pregnancy. 

It is important to note that NIPS is a screening, meaning the results are not considered a final diagnosis. Your healthcare provider can help you understand your results and decide next steps, which may include confirmatory diagnostic testing.

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NIPS reduces the number of invasive confirmatory procedures performed in unaffected pregnancies. 2-6

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NIPS can provide accurate prenatal insights earlier than current screening and diagnostic tests. 7-8

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NIPS is more accurate than other screening tests and it carries no risk of miscarriage. 2-3, 7-9

Use cases in which early insights help our patients

Prenactive NIPS

Screens for the following:

Prenactive NIPS Plus

Screens for all of the aneuploidies reported on with Prenactive NIPS, with the addition of any of the following:

NIPS detections rates

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Down syndrome T21

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Edwards syndrome T18

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Patau syndrome T13

Benefits of NIPS

  • Proven superiority to traditional screening methods with higher detection rates, reduced false positive rates
  • Offers the highest reported detection rate for Down syndrome7
  • Offers the lowest reported false positive rate for Down syndrome7
  • Offers the broadest screening window (performed as early as 10 weeks gestation until term)7-8
  • Fast turnaround time1
  • Lowest published failure rate in the industry, 0.1%1,10-11

Genetic Counseling

SDxLabs board-certified genetic counselors are available to help you understand how noninvasive prenatal screening works, the conditions it screens for, and the possible results it could give. Post screening, our genetic counselors can help you understand results and assist in navigating next steps, such as options for diagnostic testing. Genetic counseling services may also be available through your healthcare provider. Speak with provider for additional details. Genetic counseling may be required for prior authorization.

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Making noninvasive prenatal screening available to all patients

We are committed to providing access to accurate and affordable screenings to help patients make informed choices about their health and their baby’s. Every situation is unique, and we don’t want cost to be a barrier to care. Learn more about financial assistance.

Clear, concise results

Each condition screened for with Prenactive NIPS is reported individually with “High-Risk” or “Low-Risk” results. High-risk results indicate an increased concern for this condition in the pregnancy and, [in trisomy 21, 18, and 13] a percentage (the positive predictive value) is given to indicate the chance the pregnancy is affected. Genetic counseling, ultrasound, and the option of diagnostic testing are recommended following a high-risk NIPS result. Low-risk results are very reassuring that the pregnancy is likely unaffected by that condition.

Limitations of the screen

Noninvasive prenatal screening (NIPS) is a screening; it is not a diagnostic test. False positive and false negative results may occur. Further confirmatory testing is necessary prior to making any irreversible pregnancy decisions. A negative result does not eliminate the possibility that the pregnancy has one of the conditions tested. This test does not screen for other chromosomal conditions such as triploidy, birth defects such as open neural tube defects, single gene disorders, or other conditions, such as autism. There is a small possibility that the test results might not reflect the chromosomal status of the pregnancy, but may instead reflect chromosomal changes in the placenta, a demised twin, or the mother, that may or may not have clinical significance.

Frequently asked questions about NIPS

References

  1. Taneja, P. A., Snyder, H. L., de Feo, E., Kruglyak, K. M., Halks-Miller, M., Curnow, K. J., & Bhatt, S. (2016). Noninvasive prenatal testing in the general obstetric population: Clinical performance and counseling considerations in over 85 000 cases: NIPT in the general obstetrics population. Prenatal Diagnosis, 36(3), 237-243. https://doi.org/10.1002/pd.4766
  2. Bianchi, D. W., Parker, R. L., Wentworth, J., Madankumar, R., Saffer, C., Das, A. F., Craig, J. A., Chudova, D. I., Devers, P. L., Jones, K. W., Oliver, K., Rava, R. P., Sehnert, A. J., & CARE Study Group. (2014). DNA sequencing versus standard prenatal aneuploidy screening. The New England Journal of Medicine, 370(9), 799-808. https://doi.org/10.1056/NEJMoa1311037
  3. Chudova, D. I., Sehnert, A. J., & Bianchi, D. W. (2016). Copy-number variation and false positive prenatal screening results. The New England Journal of Medicine, 375(1), 97-98. https://doi.org/10.1056/NEJMc1509813
  4. Gil, M. M., Quezada, M. S., Revello, R., Akolekar, R., & Nicolaides, K. H. (2015). Analysis of cell‐free DNA in maternal blood in screening for fetal aneuploidies: Updated meta‐analysis. Ultrasound in Obstetrics & Gynecology, 45(3), 249-266. https://doi.org/10.1002/uog.14791
  5. Platt, L. D., MD, Janicki, M. B., MD, Prosen, T., MD, Goldberg, J. D., MD, Adashek, J., MD, Figueroa, R., MD, Rodis, J., MD, Liao, W., PhD, Sehnert, A. J., MD, Snyder, H. L., MS, & Warsof, S. L., MD. (2014). Impact of noninvasive prenatal testing in regionally dispersed medical centers in the united states. American Journal of Obstetrics and Gynecology, 211(4), 368.e1-368.e7. https://doi.org/10.1016/j.ajog.2014.03.065
  6. Larion, S., Warsof, S. L., Romary, L., Mlynarczyk, M., Peleg, D., & Abuhamad, A. Z. (2014). Association of combined first-trimester screen and noninvasive prenatal testing on diagnostic procedures. Obstetrics and Gynecology (New York. 1953), 123(6), 1303-1310. https://doi.org/10.1097/AOG.0000000000000275
  7. Practice Bulletin No. 163: Screening for Fetal Aneuploidy. (2016). Obstetrics and gynecology, 127(5), e123–e137. https://doi.org/10.1097/AOG.0000000000001406
  8. Gil, M. M., Accurti, V., Santacruz, B., Plana, M. N., & Nicolaides, K. H. (2017). Analysis of cell-free DNA in maternal blood in screening for aneuploidies: Updated meta-analysis: Cell-free DNA in screening for aneuploidies. Ultrasound in Obstetrics & Gynecology, 50(3), 302-314. https://doi.org/10.1002/uog.17484
  9. Benn, P., Borrell, A., Chiu, R. W. K., Cuckle, H., Dugoff, L., Faas, B., Gross, S., Huang, T., Johnson, J., Maymon, R., Norton, M., Odibo, A., Schielen, P., Spencer, K., Wright, D., & Yaron, Y. (2015). Position statement from the chromosome abnormality screening committee on behalf of the board of the international society for prenatal diagnosis: Chromosome abnormality screening statement. Prenatal Diagnosis, 35(8), 725-734. https://doi.org/10.1002/pd.4608
  10. McCullough, R. M., Almasri, E. A., Guan, X., Geis, J. A., Hicks, S. C., Mazloom, A. R., Deciu, C., Oeth, P., Bombard, A. T., Paxton, B., Dharajiya, N., & Saldivar, J. (2014). Non-invasive prenatal chromosomal aneuploidy testing - clinical experience: 100,000 clinical samples. PloS One, 9(10), e109173-e109173. https://doi.org/10.1371/journal.pone.0109173
  11. Ryan, A., Hunkapiller, N., Banjevic, M., Vankayalapati, N., Fong, N., Jinnett, K. N., Demko, Z., Zimmermann, B., Sigurjonsson, S., Gross, S. J., & Hill, M. (2016). Validation of an enhanced version of a single-nucleotide polymorphism-based noninvasive prenatal test for detection of fetal aneuploidies. Fetal Diagnosis and Therapy, 40(3), 219-223. https://doi.org/10.1159/000442931

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