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PreNatSure|NIPT

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Advantage of PreNatSure Prenatal Test

The PreNatSure Prenatal Test is a simple blood test that screens for the most common chromosomal abnormalities that can affect your baby’s future health. A sample can be drawn in your doctor’s office as early as the 10th week of pregnancy. It may help you avoid more invasive procedures, such as amniocentesis or chorionic villus sampling (CVS), which can pose risks to you and your baby. 

Is the PreNatSure Test right for me?

The PreNatSure Test offers parents-to-be a new choice to obtain important information about the health of their developing baby, simply, accurately and in the first trimester, with little or no risk to their pregnancy.This screening test is usually offered to pregnant women identified by their doctor to be at risk for fetal aneuploidy, which includes:

  • Advanced maternal age 35+ years and/or
  • Your serum screen is “positive” or abnormal
  • Your ultrasound reveals abnormalities with fetal growth and/or development
  • You have a  personal  or  family  history  suggestive  of Trisomies 21, 18, 13

Please consult your doctor for PreNatSure testing.

What kind of conditions can the PreNatSure Test detect?

The PreNatSure Prenatal Test looks for too few or too many copies of chromosomes. Missing or extra copies of chromosomes are called “aneuploidies” and are often associated with mental or physical disabilities with different levels of severity. The most commonly seen aneuploidies include Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome), and Trisomy 13 (Patau syndrome), all of which can be screened with the PreNatSure Test.

Your test report will include one of three possible results  for Chr- 21, 18, and 13:

  • No Aneuploidy detected —This means the correct number of chromosomes was found.         
  • Aneuploidy detected —This means too many or too few copies of one of the chromosomes have been identified. This result can indicate a chromosome abnormality. Your provider may advise a diagnostic test for confirmation.
  • Aneuploidy suspected —This is a borderline result, which occurs infrequently, and suggests there might be too many copies of a chromosome present. Your provider may advise a diagnostic test for confirmation.

What are my current testing options?

Today, there are a number of genetic testing options  available  for expectant women and their health care providers. Traditional screening tests are used to predict the chance of a pregnancy having certain chromosomal conditions. Some screening tests require more than one office visit to perform multiple blood draws and ultrasound examinations at very specific times during pregnancy. Results from screening tests usually provide a “risk score” (such as 1 in 500 or 1 in 50) that describes the chance of a baby developing a certain chromosome problem. These tests do not provide definitive answers and can have a relatively high rate of “false negative” or “false positive” results. But not all screening tests are the same in terms of accuracy and convenience.

Diagnostic tests, such as amniocentesis or CVS, can accurately determine whether a pregnancy has trisomy 21 (Down syndrome) or other chromosomal conditions. However, the invasive nature of these procedures poses a risk of complications, including miscarriage. The new test PreNatSure-prenatal screening is safer, quicker and more accurate is the choice for advance screening.

Why should I choose the PreNatSure Test over other tests?

The PreNatSure Test provide early information about chromosomal health of your unborn baby—providing the reassurance of reliable answers no other screening test can be compared to similar options, the PreNatSure Prenatal Test offers accurate information, rather than calculating chances or risk scores. And, it does not carry the risk of complications that invasive procedures do. It also:

  • Uses a simple, single blood draw from your arm— just 1 tube of blood is all that’s needed.
  • Can be drawn conveniently in your doctor’s office— as early as 10 weeks.
  • Provides reliable answers about the most common chromosomal abnormalities.
  • Has the lowest test failure in its class (0.1%)1—which means there is no need for additional blood draws and the inconvenience of another office visit.
  • Delivers results fast—results are usually sent to our partner laboratory in 2-4 weeks after sample receipt. 

How does the PreNatSure Test work?

A sample of your blood is drawn, and the cfDNA  is extracted to analyze millions of DNA fragments per sample and count the number of chromosomes present. It then uses a special SAFeR™ calculation method to determine if there are too many or too few copies of these chromosomes in your baby.

What do my PreNatSure Test results mean?

Your results will tell your doctor whether trisomies 21, 18 or 13 are highly likely to be present in your pregnancy. In the case of a positive result, your health care provider will discuss your results as well as further testing options to consider. It is recommended that no irreversible clinical decisions be made based on these screening results alone. If a definitive diagnosis is desired, chorionic villus sampling or amniocentesis should be considered.

How do I know I can trust the PreNatSure Test?

The performance of the PreNatSure Prenatal Test was evaluated in a major validation study that involved more than 60 leading US medical research and teaching institutions. The study findings were reviewed and published in the leading journal read by obstetricians and gynecologists.3 A second study, published subsequently, presented the test’s performance under regular clinical conditions and found similar results.

Do normal PreNatSure Test results mean that my baby will be perfectly healthy?

The PreNatSure Prenatal Test is a highly accurate noninvasive advanced screening test. No test, however, can guarantee a baby will not have any medical issues. The PreNatSure Test addresses aneuploidies of chromosomes 21, 18, 13. It does not test for or report 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, in your baby.

Genetic counseling before and after testing is recommended. Results of Aneuploidy Detected or Aneuploidy Suspected are considered positive, and women who receive such results should be offered invasive prenatal procedures for confirmation. A negative test does not ensure an unaffected pregnancy. CVS and amniocentesis provide definitive diagnostic information, but their invasive nature is a potential concern. The reassurance of reliable answers— simply, safely, sooner.

A simple non-invasive blood test

  • Safe from procedural risks of invasive procedures (amniocentesis/CVS)
  • Lowest test failure rate among noninvasive prenatal tests
  • Fast results—usually sent to the laboratory within 2 weeks after sample receipt