EnVISION Non-Invasive Prenatal® Screening
Understand Non-invasive Prenatal Test (NIPT) and Understand NIPT Results
Advancements in genetic testing have revolutionized the detection of fetal chromosomal abnormalities, utilizing the analysis of cell-free DNA (cfDNA) derived from the fetal placenta in maternal blood.
Recommendations for Testing
Recently updated clinical management guidelines from the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal Fetal Medicine (SMFM) unequivocally endorse Non-Invasive Prenatal Testing (NIPT) as the most sensitive and specific screening method for common fetal aneuploidies. These guidelines recommend that all pregnant women, irrespective of age or other risk factors, should be offered prenatal screening for fetal chromosomal abnormalities.
As an expecting mother, you have three options to consider regarding prenatal screening:
- Opting for no prenatal genetic testing or waiting until after your baby is born.
- Choosing prenatal genetic testing during pregnancy. If the screening results indicate a high risk for a genetic condition, consider diagnostic testing such as chorionic villus sampling (CVS) or amniocentesis.
- Bypassing prenatal genetic testing and directly opting for diagnostic testing, namely CVS or amniocentesis.
Non-Invasive Prenatal Testing or Cell-Free DNA Screening
NIPT is an optional blood test that can be conducted any time after 10 weeks of pregnancy. It provides information on the likelihood or risk of your developing baby having:
- Down syndrome (Trisomy 21)
- Edwards Syndrome (Trisomy 18)
- Patau Syndrome (Trisomy 13)
- Sex chromosome aneuploidy disorders
- Genetic conditions related to copy number changes such as 22q microdeletion syndrome
NIPT can also predict the gender of your baby in most cases, if desired.
NIPT Frequently Asked Questions
During pregnancy, a woman’s blood contains fragments of DNA, including cell-free DNA from the placenta, which shares genetic characteristics with the developing baby.
Analysis of these DNA fragments in the mother’s blood can indicate whether the baby has an increased or decreased likelihood of certain genetic conditions.
NIPT is a screening test that assesses whether your pregnancy is at a higher or lower risk for certain genetic conditions. However, it’s important to note that NIPT is a screening test and not a diagnostic test. If your NIPT results indicate a low risk, the chance of your baby having the condition is reduced but not eliminated. Conversely, if the results suggest a high risk, further diagnostic testing such as CVS or amniocentesis is recommended.
Your doctor may refer you to a Genetic Counselor to discuss your test results.
Diagnostic testing, such as CVS or amniocentesis, directly examines your developing baby’s DNA to conclusively determine the presence or absence of a genetic condition. These procedures involve inserting a fine needle into the abdomen to collect cells for DNA analysis.
The decision to undergo any prenatal genetic test is deeply personal and may vary from person to person. It’s essential to be well-informed about the advantages and limitations of NIPT and other prenatal testing options before making a decision.
NIPT Testing Options
EnVISION Prenatal® Screening
EnVISION Prenatal® Screening is a major advance in prenatal testing based on genome deep sequencing. It is a non-invasive screening test (NIPT) that enables assessment of over or under representation of chromosomes from maternal whole blood samples. The test is developed by Otogenetics using Illumina VeriSeq NIPT Solution with the VeriSeq Assay Software. The validated NIPT screening test provides the information for chromosomes 21, 18, 13, X and Y with increased risks for trisomy 21, 18, 13 and sex chromosome aneuploidies reported. Gender information is available for reporting. The test reports for both singleton and twin pregnancies. 22q11.2 microdeletions can be selected for analysis and reporting for singleton pregnancies.
EnVISION Prenatal® Screening has the lowest redraw rate and not-resulted rate. The redraw rate is 0.64%, the lowest in the industry. In addition, 87.5% of the redraws are resulted. The overall not-resulted rate is 0.08%, the lowest in the industry.
FAQ's Billing & Insurance FAQs
Every patient should have access to highly accurate and affordable genetic testing. Otogenetics is committed to work with each patient to reach payment solutions. These may include:
- Working with your insurance provider to verify coverage.
- Flexible payment options billed over several months.
- Financial assistance for patients who qualify.
We encourage patients to call us for all billing questions, and to discuss payment solutions.
Please call us toll free at 1-855-686-4363, option 1.
Otogenetics is committed to working with patients to ensure that everyone has access to testing without financial burden.
- Medicaid patients will NOT have patient out of pocket responsibility.
- We treat all out-of-network claims as if they are in-network.
- We will work with all insurers (primary and secondary policies) to maximize your qualified coverage.
Otogenetics testing service is covered by many insurance plans, the exact amount you owe may vary based on your individual plan and financial situation.
Here is our commitment to you regarding costs:
- We will reach out to you if we estimate your cost could be more than $50 (the average out of pocket Otogenetics patients pay).
- We will discuss the estimate with you, and review your affordability.
You may receive information from your insurer, known as an Explanation of Benefits (EOB), regarding the test you received from Otogenetics.
An EOB from your insurer is NOT A BILL.
A bill for the test(s) provided by Otogenetics comes ONLY from Otogenetics.
If there is any patient out of pocket cost after Otogenetics has exhausted all options for reimbursement coverage and financial assistance, Otogenetics will reach out to you, the patient.
Next Steps
To get started, talk to your healthcare provider about requesting a prenatal and/or carrier screen.
Your healthcare provider will take a blood draw and send it to our lab.
Otogenetics will analyze your DNA sample using our state-of-the-art technologies.
Once your screen is complete, your healthcare provider or a genetic counselor from Otogenetics may contact you to explain your results and answer any questions you have.