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.
NIPS reduces the number of invasive confirmatory procedures performed in unaffected pregnancies. 6,10,11,12
NIPS can provide accurate prenatal insights earlier than current screening and diagnostic tests. 6,10,11,13
NIPS is more accurate than other screening tests and it carries no risk of miscarriage. 6,14,11,10
Use cases in which early insights help our patients
At Maria’s 12-week ultrasound, the pocket of fluid at the back of the baby’s neck, called the nuchal translucency, measured larger than expected. This finding is associated with an increased risk for chromosomal abnormalities. The patient was offered the option of invasive diagnostic testing, NIPS, or to return in 4 weeks for a follow-up ultrasound. Maria was very anxious to learn more about her pregnancy but was hesitant to proceed with an invasive procedure without knowing more. She elected to do NIPS so she could quickly and safely get more information about the health of her pregnancy and could use this information to help her decide if invasive diagnostic testing was needed.
Family History Concerns
Janet and Tom have a 2-year-old son, Tyler, and they were excited to be expecting their second baby. Tyler was born with Down syndrome, a fact they did not know until delivery. Because of the family history, there was an increased risk for other pregnancies to also have chromosomal conditions. Reflecting on their experience of receiving a diagnosis of a genetic condition just after giving birth, in this pregnancy they would prefer to know ahead of time about any genetic conditions in the baby so they could be prepared.
It’s Samantha’s first pregnancy and she was both nervous and excited. She wanted to share the news with her friends and family but knew that many pregnancies miscarry due to chromosomal conditions. She decided to wait until she was 10 weeks pregnant and do NIPS because a negative result would give her confidence that her pregnancy is progressing appropriately, and she could share her happy news. She also knew that if the results did show an increased risk for a condition, she and her partner would want privacy as they navigate their next steps.
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
Down syndrome T21
Edwards syndrome T18
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 syndrome4
- Offers the lowest reported false positive rate for Down syndrome4
- Offers the broadest screening window (performed as early as 10 weeks gestation until term)4-6
- Fast turnaround time1
- Lowest published failure rate in the industry, 0.1%1-3
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.
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
- Taneja PA, Snyder HL, de Feo E, et al. Noninvasive prenatal testing in the general obstetric population: clinical performance and counseling considerations in over 85 000 cases. Prenat Diagn. 2016;36(3):237-243.
- McCullough RM, Almasri EA, Guan X, et al. Non-invasive prenatal chromosomal aneuploidy testing--clinical experience: 100,000 clinical samples. PLoS One. 2014;9(10):e109173.
- Ryan A, Hunkapiller N, Banjevic M, 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.
- Practice Bulletin No. 163: Screening for Fetal Aneuploidy. Obstet Gynecol. 2016;127(5):979-981.
- Gregg AR, Skotko BG, Benkendorf JL, et al. Noninvasive prenatal screening for fetal aneuploidy, 2016 update: a position statement of the American College of Medical Genetics and Genomics. Genet Med. 2016;18(10):1056-1065.
- Bianchi DW, Parker RL, Wentworth J, et al. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014;370(9):799-808.
- ACOG guidelines recommend NIPT for all pregnancies regardless of risk (2020). GenomeWeb. Retrieved from https://www.genomeweb.com/molecular-diagnostics/acog-guidelines-recommend-nipt-all-pregnancies-regardless-risk#.Y8hH2HbMKUk.
- Practice bulletin no. 163: Screening for fetal aneuploidy. Obstet Gynecol. 2016;127(5):e123-137.
- American College of Obstetricians and Gynecologists. Screening for fetal aneuploidy. Practice bulletin no. 163. Obstet Gynecol. 2016;127(5):e123-e137.
- Chudova DI, Sehnert AJ, Bianchi DW. Copy-number variation and false positive prenatal screening results. N Engl J Med. 2016;375(1):97-98. 8
- Gil MM, Quezada MS, Revello R, Akolekar R, Nicolaides KH. Analysis of cell-free DNA in maternal blood in screening for fetal aneuploidies: updated meta-analysis. Ultrasound Obstet Gynecol. 2015;45(3):249-266.
- Larion S, Warsof SL, Romary L, Mlynarczyk M, Peleg D, Abuhamad AZ. Association of combined first-trimester screen and noninvasive prenatal testing on diagnostic procedures. Obstet Gynecol. 2014;123(6):1303-1310.
- Platt LD, Janicki MB, Prosen T, et al. Impact of noninvasive prenatal testing in regionally dispersed medical centers in the United States. Am J Obstet Gynecol. 2014;211(4):368.e1-368.e7.
- Benn P, Borrell A, Chiu RWK, et al. Position statement from the Chromosome Abnormality Screening Committee on behalf of the Board of the International Society for Prenatal Diagnosis. Prenat Diagn. 2015;35(8):725-734.