Offer EVITA TEST COMPLETE in your clinic
EVITA TEST COMPLETE is the first and only cell-based NIPT that screens all 23 chromosome pairs for possible aneuploidies and genome-wide copy number variations as well as specific microdeletion syndromes with enhanced sensitivity.
Samples are analyzed in Denmark using patented technology.
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Offer EVITA TEST COMPLETE in your clinic
EVITA TEST COMPLETE is the only NIPT test that screens all 23 chromosome pairs for possible aneuploidies and genome-wide copy number variations with resolution down to 1 Mb, as well as specific microdeletion syndromes with enhanced sensitivity down to 0.4 Mb.
Samples are analyzed in Denmark using patented technology, and results are reviewed by Danish genetic specialists ensuring clinical accuracy and reliability.
How EVITA TEST COMPLETE works
Watch the video to learn about the technology behind EVITA TEST COMPLETE.
EVITA TEST COMPLETE vs. traditional NIPTs
Watch how EVITA TEST COMPLETE differs from traditional NIPTs in detecting genetic abnormalities prenatally.
How to start offering EVITA TEST COMPLETE to the pregnant women
Requesting EVITA TEST COMPLETE requires a simple 3 step process
After entering the required information, you will receive a confirmation email.
Upon registration, we will contact you to finalize your account and provide the required information.
We will send you test kits (EN ISO 13485:2016) and instructions for ordering more EVITA TEST COMPLETE.
Offer EVITA TEST COMPLETE
For new clinic partners.
For already registered clinic partners.
If you have any questions, send us an email at contact@arcedi.com.
Step-by-step guide to the EVITA TEST COMPLETE
The EVITA TEST COMPLETE requires a simple 5 step process
The test kit the clinic receives contains everything needed to carry out the blood sampling.
The clinic takes a blood sample from the pregnant woman – 30 ml is drawn.
The blood sample is sent to ARCEDI, which processes the sample (isolates the fetal cells and prepares fetal DNA for analysis).
Clinical Genomics Specialists carry out genetic analysis and give the results to the clinic in the form of a short report.
In the event of a normal test result, the clinic notifies the parent(s) via a phone call, followed by a short report.
If the test indicates a risk of a chromosomal abnormality in the fetus, the clinic will advise and guide the parents to have a consultation with a specialist. This often includes a placental or amniotic fluid biopsy at the hospital to confirm the findings.
Want to know more about NIPT?
EVITA TEST COMPLETE versus other NIPTs
EVITA TEST COMPLETE is a cell-based Non-Invasive Prenatal Test. There are other types of tests called cell-free Non-Invasive Prenatal Test which are available on the market today, but EVITA TEST COMPLETE is the only one that:
- Is based on the analysis of whole and pure fetal cells with the complete fetal genome.
- Screens the entire genome for aneuploidies and any pathogenic (disease causing) deletions and dulpications as small as 1 million base pairs (Mb)* in size in .¤
- Additionally, it screens selected regions associated with known syndromes for even smaller pathogenic deletions and duplications ≥ 0.4 Mb.¤
- Can be used by all pregnant women regarless of their own genetics or BMI.
The differences between the various prenatal test types can be seen below.
* Human chromosomes come in different sizes, the largest being Chromosome 1 (249 Mb), and the smallest Chromosome 21 (54 Mb)
¤ These syndromes are from the DECIPHER database (Grade 1), and are reported according to the Danish national prenatal reporting guidelines.
The combination of complete insight into possible chromosomal abnormalities along with the fact that the test is completely risk-free makes EVITA TEST COMPLETE the safest choice.
Sensitivity and specificity
EVITA TEST COMPLETE, has been developed together with researchers from Aarhus University Hospital. Between 2018 and 2023 a clinical validation study was conducted in the Central Region on 344 pregnancies.
The results are published in the journal; Prenatal Diagnosis: How does cell-based NIPT perform against chorionic villus sampling and cell-free NIPT in detecting trisomies and copy number variations? A clinical study from Denmark.
Based on this published data, and recent unpublished data, sensitivity and specificity have been calculated for cbNIPT, EVITA TEST COMPLETE:
- Sensitivity is a measure of how many with abnormal genetics are correctly identified as abnormal in the test
- Specificity is a measure of how many with normal genetics are correctly identified as normal in the test.
Syndromes EVITA TEST COMPLETE screens for
EVITA TEST COMPLETE screens all fetal chromosomes for aneuploidies (gain or loss of a complete chromosome eg. Downs syndrome is caused by an extra copy of chromosome 21) and deletion and duplication syndromes, also called copy number variations (CNVs), where parts of a chromosome are duplicated or deleted. Fortunately, deletion and duplication syndromes are rare, but can occur anywhere within the different chromosomes. Some deletions and/or duplications are more frequent and have a syndrome named after them, while others are rarer and often de novo (new) but can still be serious.
EVITA TEST COMPLETE tests for aneuploidies and any pathogenic (disease causing) deletions and dulpications as small as 1 million base pairs (Mb)* in size in .¤
Additionally, smaller pathogenic deletions and duplications ≥ 0.4 Mb in selected regions associated with known syndromes are reported.¤
* Human chromosomes come in different sizes, the largest being Chromosome 1 (249 Mb), and the smallest Chromosome 21 (54 Mb)
¤ These syndromes are from the DECIPHER database (Grade 1), and are reported according to the Danish national prenatal reporting guidelines.
Genomewide, pathogenic copy number variations
- > 1 Mb for deletions
- > 1 Mb for duplications
Number errors (loss or increase of an entire chromosome)
All aneuploidies on the autosomal chromosomes – i.e. chromosomes 1-22.
For example:
- Trisomy 21 – Downs syndrome
- Trisomy 18 – Edwards syndrome
- Trisomy 13 – Pataus syndrome
Number errors of the sex chromosomes
- X0 – Turner syndrome
- XXY – Klinefelters syndrome
- XYY – Jacobs syndrome
Selected deletions and duplications (≥0.4 Mb) in regions associated with known syndromes.
- Prader-Willi syndrome (type 2)
- Angelman syndrome (type 2)
- Williams syndrome
- 1p36 microdeletion syndrome
- Cri-du-chat Syndrome (5p deletion)
- Wolf-Hirschhorn syndrome
- 22q11 deletion syndrome (Velocardiofacial / DiGeorge syndrome)
- Smith-Magenis syndrome
- 2q33.1 deletion syndrome
- 2q37 monosomy
- Sotos syndrome
- 9q subtelomeric deletion syndrome
- Potocki-Shaffer syndrome
- ATR-16 syndrome
- Rubinstein-Taybi Syndrome
- Miller-Dieker syndrome (MDS)
- NF1-microdeletion syndrome
- 17q21.31 recurrent microdeletion syndrome (Koolen de Vries syndrome)
- 22q13 deletion syndrome (Phelan-Mcdermid syndrome)
Test restrictions
EVITA TEST COMPLETE is not yet a diagnostic test, it is a screening test like the other NIPT tests. Thus, a positive test finding of an anomaly needs to be confirmed with a followup invasive diagnostic test. A positive screening result means that a fetus has a high risk of having a specific genetic chromosomal abnormality. Consequently, any medical decisions regarding the screening test results should only be taken after a discussion with a medical doctor or specialist health care professional.
In a small number of maternal blood samples (5%), not enough fetal cells can be found to carry out the chromosome examination. In this case, a new blood test (within the gestational age of 10+0 -14+6) is offered. After this point, the number of samples where a chromosome examination of the fetus cannot be completed drops to 2%. If still unsuccessful at this point in time a refund is provided.
Development work is ongoing for clinical validation of EVITA TEST COMPLETE for:
- Deletions/duplications below 5 million DNA base pairs in size
- Twin pregnancies
- Monogenic diseases (mutation in a single gene, e.g. cystic fibrosis)
- Mosaicism (a small fraction of cells in the placenta or fetus have a chromosomal abnormality)
EVITA TEST COMPLETE cannot be used to test for:
- Polyploidy (more than two of each kind of chromosomes)
- Balanced translocations (exchange of chromosomal material between two different chromosomes, but the total amount of the chromosomes is unchanged
- Uniparental disomy (UPD) (two copies of a chromosome are inherited from only one parent)
Do you need additional information?
If you are interested in becoming our next clinic partner or if you would like further information about the test, contact ARCEDI (the Danish company that developed the test).
You can call us on weekdays from 9.00am to 15.30 on +45 93 96 00 00.
Alternatively, you can send us an email at: contact@arcedi.com.
We look forward to hearing from you.