All about the verifi® prenatal test
Background / introduction to chromosomal abnormalities:
Chromosomes are structures which carry all of our genetic information and serve as the blueprint for how we grow and develop. Humans typically have 46 chromosomes, arranged into 23 pairs. The first 22 pairs are numbered (1-22) and are the same in males and females. The remaining pair is the sex chromosomes; males have one X and one Y sex chromosome, while females usually have two X sex chromosomes. The most common aneuploidies seen at birth are trisomy 21 (three copies of chromosome 21, instead of the usual two copies), trisomy 18 (three copies of chromosome 18), trisomy 13 (three copies of chromosome 13), and sex chromosome aneuploidies (a change in the usual number of X or Y chromosomes.) Examples of sex chromosome aneuploidies include Turner syndrome (only one X chromosome in a female) and Klinefelter syndrome (an extra X chromosome in a male).
What is the verifi® prenatal test?
The verifi® prenatal test was developed by Verinata Health, Inc. The verifi® prenatal test measures genetic material (or DNA) from a pregnant woman's blood to look for too few or too many copies of chromosomes in the mother and baby. Missing or extra copies of chromosomes are referred to as "aneuploidies" and may be related to conditions in pregnancy such as trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), or trisomy 13 (Patau syndrome).
The test can also look for other conditions caused by missing and extra copies of other types of chromosomes, called sex chromosomes (X and Y).
Trisomies occur when three, instead of the usual two, copies of a chromosome are present. Sex chromosome aneuploidies are conditions in which there is a change from the usual 2 copies of sex chromosomes in males (XY) or females (XX). All of these conditions may cause mental or physical defects, with different levels of severity.
This test is available for singleton and twin pregnancies.1
1 The verifi® prenatal test for chromosomes 21, 18, and 13, is available for singleton and twin pregnancies. Sex chromosomes aneuploidy testing is available for singleton pregnancies only. An optional test for twin pregnancies tests for the presence of the Y chromosome, which can provide information about fetal sex.
How does it work?
A sample of your blood is drawn and the genetic material is tested. This test uses a technology called "massively parallel DNA sequencing" to count the number of copies of these chromosomes, and then uses a calculation method to determine if there are too many or too few copies of these chromosomes present in your fetus.
How do I know if this test is right for me?
This test is usually offered to pregnant women identified by their doctor to have a chance of fetal aneuploidy. The verifi® test offers a new choice to women to have information about their pregnancy, as accurately as possible from a simple blood draw, with little or no risk to their pregnancy.
This screening test may be an option for you to consider if:
You have a confirmed singleton or twin pregnancy of at least 10 weeks gestational age, and meet any of the following criteria:
- You are considered to be of advanced maternal age (35 years or older (singleton pregnancy) or 32 years or older (twin pregnancy) at time of delivery)
- You have an abnormal or "positive" serum screen
- Your ultrasound shows concerns or abnormalities with fetal growth and/or development
- You have a personal or family history of chromosomal aneuploidies for trisomies 21, 18, 13, or other sex chromosome aneuploidies
I don't have an increased risk for Down syndrome, but I am really worried about it. Can I have this test?
Our validation studies were performed on women considered to be at increased risk for certain chromosomal conditions, including Down syndrome. Professional medical societies, including the American College of Obstetricians and Gynecologists, have issued committee opinions supporting the use of this test in high risk women. Please discuss your testing options with your healthcare provider, who will determine the best options and recommendations for you.
What are my current testing options?
There are various screening and diagnostic options available for the common chromosomal conditions. Current screening options can tell you the chance (for example, 1 in 50 or 1 in 5000) of your pregnancy having a certain chromosome problem, but they do not provide a definitive answer. Current invasive procedures (such as a CVS or amniocentesis) can provide a more definitive answer.
What are the advantages of the verifi® prenatal test over my current options?
In comparison to other testing options, the verifi® prenatal test provides more accurate information than calculating chances (risk scores), and does not carry the risk of complications that an invasive procedure can have.
- Uses just a simple, single blood draw from your arm
- Can be performed as early as 10 weeks
- Tests for trisomies 21, 18, and 13
- Tests for sex chromosome conditions or the presence of a Y chromosome (if this option is ordered by your healthcare provider)
How do I know the verifi® prenatal test is effective?
To document the performance of the test, Verinata Health conducted a major scientific study with more than 60 leading US medical research and teaching institutions. The clinical information presented in this study was reviewed and was published in the leading journal read by obstetricians and gynecologists.
How accurate is this test?
Please talk to your healthcare provider regarding the performance data of this test. Your healthcare provider can discuss the limitations and benefits of all testing options with you.
I would like the test as soon as possible. How soon can I get it?
The verifi® prenatal test is available as early as 10 weeks of pregnancy. You can take the test up until the end of pregnancy.
I would like this test instead of an amniocentesis. Is this possible?
This test provides you with another option for testing, which is very accurate and safe. You should speak to your healthcare provider about this test. You and your provider can discuss the benefits, limitations, and risks of all available testing to decide what the best choice might be for you.
Can I get it in my area?
The verifi® prenatal test is available in all 50 states. Please check with your health care provider, or call us at 1-855-BMOMKND.
Do I have to come to your laboratory?
No, your blood sample for the verifi® prenatal test can be collected in your healthcare provider's office. After the blood draw, your blood sample will be sent to our California-based laboratory by your health care provider or by the lab where your blood is drawn. Our laboratory is CAP-accredited and certified under CLIA as qualified to perform high complexity clinical laboratory testing. The verifi® prenatal test results will be sent directly to your healthcare provider's office. For more information, please visit: www.verinata.com/our-lab.html
Do I need to be a certain age for this test?
In most cases, you have to be at least 18 years old to be able to consent to the test. You should discuss testing with your health care provider.
What do my verifi® test results mean?
Your results will tell your doctor whether or not trisomies 21, 18, 13 or sex chromosome abnormalities (if these were ordered) are highly suspected in this pregnancy. In the case of a positive result, your health care provider may discuss what the results mean to you and your fetus as well as further testing options for your pregnancy.
Your test report will include one of three possible results for chromosomes 21, 18, and 13: No Aneuploidy Detected, Aneuploidy Detected, or Aneuploidy Suspected (Borderline Value). Sex Chromosomes will be reported as No Aneuploidy Detected, or Aneuploidy Detected. In the case of a twin pregnancy, the Y chromosome presence will be reported as Detected or Not Detected.
- A No Aneuploidy Detected test result means that this test identified the expected number of copies of chromosomes reported
- An Aneuploidy Detected test result means that this test identified too many or too few copies of one of the chromosomes as seen on the report. This can indicate either a trisomy or a sex chromosome aneuploidy
- An Aneuploidy Suspected test result means that this test identified more copies than expected of the chromosomes reported. This means that your provider should follow up on this result to obtain more information
The verifi® prenatal test is a highly accurate advanced screening test that is non-invasive. Genetic counseling before and after testing is recommended. Results of "Aneuploidy Detected" or "Aneuploidy Suspected" are considered positive and patients should be offered invasive prenatal procedures for confirmation. A negative test does not ensure an unaffected pregnancy. Chorionic villus sampling and amniocentesis provide definitive diagnostic information, but may pose harm to the fetus.
Can you tell if my baby is a boy or a girl?
If the sex chromosome option is selected, and no sex chromosome conditions (aneuploidies) are reported, then fetal sex will be reported in the result. If the sex chromosome option is not selected, then fetal sex will not be reported. For twin pregnancies, fetal sex may be reported, if this option is selected. Please let you health care provider know if you do not wish to know this information.
Can this test tell who the father of my baby is?
No. The verifi® prenatal test is not a paternity test.
Do normal verifi® prenatal test results mean that my baby will be perfectly healthy?
No test can guarantee a baby will not have any medical issues. The verifi® prenatal test only tests for aneuploidies of chromosomes 21, 18, 13, and sex chromosomes, if ordered. It does not test for all genetic and non-genetic problems that may be present in a baby. If the test result is "No aneuploidy detected", indicating a negative result, it does not completely rule out all potential problems with chromosomes 21, 18, and 13, or all sex chromosome aneuploidies in your baby.
How quickly will I get my results?
Your results will be sent to your healthcare provider. Your healthcare provider will usually receive your results within 3-6 business days.
Does insurance cover the verifi® prenatal test?
The verifi® prenatal test has been added to a list of in-network tests with Aetna, Cigna, and United Healthcare. This means that if you are a member of Aetna, Cigna, or United Healthcare, that the verifi® prenatal test is now a benefit on many plans. Members pay the lowest cost determined by their plan. The best way to confirm if the verifi® prenatal test is covered by your particular insurance plan is to contact your insurance provider. Please see our website at www.verinata.com/billing-faqs.html for an updated list of health insurance plans with in-network status. You may need to provide specific information to your insurance plan regarding the testing being performed.