OVERVIEW

VisibiliT™

Screen for the most common chromosomal abnormalities: trisomy 21 (Down syndrome) and trisomy 18 (Edwards syndrome), and identify if your baby is a boy or a girl.

Knowledge is empowering.

As early as ten weeks into your pregnancy, the VisibiliT™ laboratory-developed test can provide you with relevant genetic information about the most common chromosomal abnormalities, trisomy 21 (Down syndrome) and trisomy 18 (Edwards syndrome). The test can also tell you if you’re having a boy or a girl.



TEST DETAILS

VisibiliT™

The clear choice for screening chromosomal abnormalities.

Is my pregnancy at risk of a chromosomal abnormality?

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Anyone can have a pregnancy with a chromosomal abnormality—healthy women, mothers of all ages and all ethnicities can be at risk.

Performed as early as week 10 in your pregnancy, VisibiliT™ provides you with relevant genetic information about chromosomal abnormalities, including trisomy 21 (Down syndrome) and trisomy 18 (Edwards syndrome), and fetal sex. Results will indicate a low or high risk for each trisomy. A high risk result may warrant additional testing.

The VisibiliT™ test was designed to mirror the common fetal trisomies provided by current serum screening tests. However, VisibiliT™ offers a very low false positive rate compared to the 5% rate of prenatal serum screening.1

Your health care provider will get your test results back in about five days upon receipt of your sample to our laboratory.

While the results of the VisibiliT® test are highly accurate, discordant results, including inaccurate fetal sex prediction, may occur due to: placental, maternal, or fetal mosaicism or neoplasm; vanishing twin; prior maternal organ transplant; or other causes. This test is a screening test and not diagnostic; it does not replace the accuracy and precision of prenatal diagnosis with CVS or amniocentesis. A patient with a high risk score result should be referred for genetic counseling and offered invasive prenatal diagnosis for confirmation of test results. A low risk score result does not ensure an unaffected pregnancy nor does it exclude the possibility of other chromosomal abnormalities or birth defects which are not a part of this test. The test is not intended to identify pregnancies at risk for neural tube defects or ventral wall defects. Testing for whole chromosome abnormalities could lead to the potential discovery of both fetal and maternal genomic abnormalities that could have major, minor, or no clinical significance. Evaluating the significance of a positive or a non-reportable test result may involve both invasive testing and additional studies on the mother. Such investigations may lead to a diagnosis of maternal chromosomal abnormalities, which on occasion may be associated with benign or malignant maternal neoplasms. This test may not accurately identify fetal triploidy or balanced rearrangements which may be detected by prenatal diagnosis with CVS or amniocentesis. The ability to report results may be impacted by maternal BMI, maternal weight, maternal systemic lupus erythematosus (SLE) and/or certain pharmaceutical agents such as low molecular weight heparin (for example: Lovenox®, Xaparin®, Clexane® and Fragmin®). The results of this testing, including the benefits and limitations, should be discussed with a qualified health care provider. Pregnancy management decisions, including termination of the pregnancy, should not be based on the results of this test alone.



How it Works

Rest assured in five easy steps

Assess the following resources to learn more about your testing options, start the process with your physician and purchase a test.

Step 1


Explore
our genetic tests

Step 2


Talk
to your doctor

Step 3


Find
a blood draw location

Step 4


Understand
billing and insurance

Step 5

Schedule
genetic counseling


Reproductive Health

A comprehensive family planning test menu is available

Sequenom Laboratories is here for you throughout the process of understanding your genetic information.

We are the pioneer and innovation leader in family planning and prenatal testing. With the broadest suite of solutions addressing your needs from pre-conception planning to prenatal testing and invasive diagnostics, we deliver complete and accurate information when you need it.

PRE-CONCEPTION + PRENATAL CARRIER SCREENING
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NONINVASIVE PRENATAL TESTING
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Support

Committed to you

We will assist you through every testing decision.

Let Sequenom Laboratories’ knowledgeable and attentive support team guide you through your testing decisions, answer questions about billing and insurance, and provide you with personalized, live assistance.

If your test results indicate a chromosomal abnormality, our genetic counseling team is ready to explain the risk and answer your questions in terms you can easily understand. This in-depth, genetic counseling session with a board-certified genetic counselor is provided at no additional cost.

(877) 821-7266

CLIENTSERVICES@SEQUENOM.COM

OVERVIEW

VisibiliT™

Screen for fetal sex and chromosomal abnormalities such as trisomy 21 (Down syndrome) and trisomy 18 (Edwards syndrome).

Results made simple.

The VisibiliT™ laboratory-developed test has high sensitivity and specificity of greater than 99%, making it the trusted choice for noninvasive prenatal testing of patients looking for relevant genetic information about their pregnancy.



TEST DETAILS

VisibiliT™

Built on experience, the simply relevant choice for reliable cell-free DNA testing.

A track record of success

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Since Sequenom Laboratories launched noninvasive prenatal testing (NIPT) in 2011, several hundred thousand women worldwide have benefited. Many have avoided potentially unnecessary invasive procedures while gaining important information about the health of their pregnancies.

As compared to serum screening, VisibiliT™ is validated to match or exceed sensitivities at much lower rates of false positives.1


  Sensitivity Specificity
Trisomy 21 >99% (21 of 21) 95% CI (80.8-100%) >99.9% (1048 of 1048) 95% CI (99.5-100%)
Trisomy 18 >99% (10 of 10) 95% CI (65.6-100%) >99.9% (1048 of 1048) 95% CI (99.5-100%)
Fetal Gender 99.3% accuracy (1041 of 1048) 95% CI (98.6-99.7%) 99.3% accuracy (1041 of 1048) 95% CI (98.6-99.7%)

Our test can be utilized as early as ten weeks gestation.1 The results are provided in approximately five days from receipt of the sample in the laboratory.

While the results of the VisibiliT™ test are highly accurate, discordant results, including inaccurate fetal sex prediction, may occur due to: placental, maternal, or fetal mosaicism or neoplasm; vanishing twin; prior maternal organ transplant; or other causes. Cell-free DNA (cfDNA) testing does not replace the accuracy and precision of prenatal diagnosis with CVS or amniocentesis. A patient with a VisibiliT™ high risk score should be referred for genetic counseling and offered invasive prenatal diagnosis for confirmation of test results. A low risk score VisibiliT™ result does not ensure an unaffected pregnancy. The VisibiliT™ test is not intended to identify pregnancies at risk for neural tube defects or ventral wall defects. cfDNA testing for whole chromosome abnormalities could lead to the potential discovery of both fetal and maternal genomic abnormalities that could have minor, or no, clinical significance. Evaluating the significance of a positive or a non-reportable test result may involve both invasive testing and additional studies on the mother. Such investigations may lead to a diagnosis of maternal chromosomal abnormalities, which on occasion may be associated with benign or malignant maternal neoplasms. cfDNA testing may not accurately identify fetal triploidy or balanced rearrangements; these may be detected by prenatal diagnosis with CVS or amniocentesis. The ability to report results may be impacted by maternal BMI, maternal weight, and/or maternal systemic lupus erythematosus (SLE). The results of this testing, including the benefits and limitations, should be discussed with a qualified health care provider. Pregnancy management decisions, including termination of the pregnancy, should not be based on the results of this test alone.



How it Works

Give your patients the easiest path to peace of mind

Step 1


Explore
our genetic tests

Step 2


Talk
to your doctor

Step 3


Find
a blood draw location

Step 4


Understand
billing and insurance

Step 5

Schedule
genetic counseling


Reproductive Health

The most comprehensive family planning tests available

Sequenom Laboratories is here for you throughout the process of interpreting genetic information.

We are the pioneer and innovation leader in prenatal and family planning testing. With the broadest solution suite addressing your patient’s needs from pre-conception planning to noninvasive prenatal testing and invasive diagnostics, we deliver complete and accurate information.

PRE-CONCEPTION + PRENATAL CARRIER SCREENING
Last Segment: visibilit
Entry slug: heredit-universal
Last Segment: visibilit
Entry slug: heredit-cf
NONINVASIVE PRENATAL TESTING
Last Segment: visibilit
Entry slug: maternit-genome
Last Segment: visibilit
Entry slug: maternit21-plus
Last Segment: visibilit
Entry slug: visibilit
active
Last Segment 2: visibilit
Entry slug 2: sensigene-rhd
PRENATAL DIAGNOSTIC TESTING
Last Segment 2: visibilit
Entry slug 2: nextview-array


Support

Committed to patients

We will assist you in interpreting your patients’ genetic information.

Sequenom Laboratories health care providers receive consistent, knowledgeable, and attentive support with live assistance from clinical, sales, billing, and laboratory personnel to address your needs quickly. In-house billing associates and highly efficient turnaround times allow for faster answers and greater patient satisfaction.

When needed, Sequenom Laboratories genetic counselors are available for your patients who test positive, at no additional cost. Counseling provides access to board-certified genetic counselors who are skilled at explaining genetic risks in terms patients can understand. Best of all, these genetic counseling sessions allow you to increase the excellence of care your patients receive.

877.821.7266

CLIENTSERVICES@SEQUENOM.COM

References

  1. Screening for fetal chromosomal abnormalities. ACOG Practice Bulletin; Number 77, January 2007.