Overview

MaterniT® 21 PLUS

Highly accurate answers to important questions.

Knowledge is empowering.

The MaterniT® 21 PLUS laboratory-developed test can tell you if you are having a boy or a girl, and screens for both common and rare chromosomal abnormalities. The test screens for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome), and many other conditions that can affect your baby’s health.



Test Details

MaterniT® 21 PLUS

Noninvasive prenatal testing for 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.

With the MaterniT® 21 PLUS laboratory-developed test, Sequenom Laboratories introduced a highly accurate noninvasive approach to assessing chromosome information with the ease of a maternal blood draw.

As early as nine weeks gestation, the MaterniT® 21 PLUS test reports simple-to-understand results within five days after the sample is received in the laboratory.

The results offers prenatal insight on:

  • Chromosome 21 (associated with Down syndrome)
  • Chromosome 18 (associated with Edwards syndrome)
  • Chromosome 13 (associated with Patau syndrome)
  • Fetal sex
  • Sex chromosome abnormalities
  • Additional information requested by your health care provider1, 2, 3  

While the results of the MaterniT® 21 PLUS 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. Sex chromosomal aneuploidies are not reportable for known multiple gestations. A patient with a positive MaterniT® 21 PLUS test result or presence of an Additional Finding should be referred for genetic counseling and offered invasive prenatal diagnosis for confirmation of test results. A negative MaterniT® 21 PLUS test 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 absence of an Additional Finding does not indicate a negative result. The MaterniT® 21 PLUS test is not intended to identify pregnancies at risk for neural tube defects or ventral wall defects. Testing for whole chromosome abnormalities (including sex chromosomes) and for subchromosomal 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 or subchromosomal abnormalities, which on occasion may be associated with benign or malignant maternal neoplasms. This test may not accurately identify fetal triploidy, balanced rearrangements, or the precise location of subchromosomal duplications or deletions; these 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

References

  1. Palomaki GE, Kloza EM, Lambert-Messerlian GM, Haddow JE, et al. DNA sequencing of maternal plasma to detect Down syndrome: An international clinical validation study. Genet Med. 2011;13(11):913-920.
  2. Palomaki GE, Deciu C, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Grody WW, Nelson SF, Canick JA. DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13, as well as Down syndrome: An international collaborative study. Genet Med. 2012;14(3):296-305.
  3. Mazloom AR, Dzakula Z, Oeth P, Wang H , et al. Noninvasive prenatal detection of sex chromosomal aneuploidies by sequencing circulating cell-free DNA from maternal plasma. Prenat Diagn. 

Overview

MaterniT® 21 PLUS

The pioneering NIPT is now the ideal average-risk NIPT—give patients the best possible care.

Information that empowers.

The MaterniT® 21 PLUS laboratory-developed test—the first commercially available NIPT—reports fetal sex, and both more common and rare fetal chromosomal abnormalities, from trisomies 21, 18, and 13 to fetal sex aneuploidies, trisomies 16 and 22, and select microdeletions.



Test Details

MaterniT® 21 PLUS

Fast and accurate noninvasive prenatal testing for chromosomal abnormalities.

Relevant

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For pregnancies at increased risk of fetal abnormalities, the MaterniT® 21 PLUS test delivers a comprehensive NIPT for the analysis of chromosomal regions including trisomies 21, 18, and 13, fetal sex, sex chromosome aneuploidies, and an enhanced sequencing series that examines seven clinically-relevant microdeletions.

Our research has been validated in the largest-of-its-kind, independently designed, analyzed, and published clinical study.

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

Core test results (trisomy 21, 18, and 13) are reported as a positive or negative; never a percentage, and never a maybe. With very low published (0.9%) and commercial (~1.5%) non-reportable rates, your patients can count on fast, clear answers and accurate results, and may avoid a retest or a potentially unnecessary invasive procedure.

While the results of the MaterniT® 21 PLUS 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 positive MaterniT® 21 PLUS test result should be referred for genetic counseling and offered invasive prenatal diagnosis for confirmation of test results. A negative MaterniT® 21 PLUS test result does not ensure an unaffected pregnancy. The MaterniT® 21 PLUS test is not intended to identify pregnancies at risk for neural tube defects or ventral wall defects. cfDNA testing for whole chromosome abnormalities (including sex chromosomes) and for subchromosomal 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 or subchromosomal abnormalities, which on occasion may be associated with benign or malignant maternal neoplasms. cfDNA testing may not accurately identify fetal triploidy, balanced rearrangements, or the precise location of subchromosomal duplications or deletions; 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.

The MaterniT 21 PLUS test has been validated in multiple, independently designed, analyzed, and published clinical studies, which tested samples from a cumulative total of more than 2,100 pregnant women. 1,2,3,4

Positive results Sensitivity Specificity
210 of 212 - trisomy 21 99.1% 99.9%
59 of 59 - trisomy 18 > 99.9% 99.6%
11 of 12 - trisomy 13 91.7% 99.7%
8 of 8 multiple gestations: -7 of trisomy 21 | 1 of trisomy 13 > 99.9% detection rate > 99.9% detection rate
Fetal sex 99.4% accuracy 99.4% accuracy
25 of 26 combined sex chromosome aneuploidies 96.2% 99.7%


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: maternit21-plus
Entry slug: heredit-universal
Last Segment: maternit21-plus
Entry slug: heredit-cf
NONINVASIVE PRENATAL TESTING
Last Segment: maternit21-plus
Entry slug: maternit-genome
Last Segment: maternit21-plus
Entry slug: maternit21-plus
active
Last Segment: maternit21-plus
Entry slug: visibilit
Last Segment 2: maternit21-plus
Entry slug 2: sensigene-rhd
PRENATAL DIAGNOSTIC TESTING
Last Segment 2: maternit21-plus
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. Palomaki GE, Kloza EM, Lambert-Messerlian GM, Haddow JE, et al. DNA sequencing of maternal plasma to detect Down syndrome: An international clinical validation study. Genet Med. 2011;13(11):913-920.
  2. Palomaki GE, et al. DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13, as well as Down syndrome: An international collaborative study. Genet Med. 2012;14(3):296-305.
  3. Canick JA, et al. DNA sequencing of maternal plasma to identify Down syndrome and other trisomies in multiple gestations. Prenat Diagn. 2012 Aug;32(8):730-4
  4. Mazloom AR, et al. Noninvasive prenatal detection of sex chromosomal aneuploidies by sequencing circulating cell-free DNA from maternal plasma. Prenat Diagn. 2013 Jun;33(6):591-7.