Offer EVITA TEST COMPLETE in your clinic

EVITA TEST COMPLETE is the only NIPT test on the market today, which is based on intact fetal cells and which examines all 23 pairs of chromosomes of the fetus for possible abnormalities. A blood sample from a pregnant woman is analyzed with a patented technology and evaluated by a geneticist in Denmark.

Modelfoto

Modelfoto

OFFER EVITA TEST COMPLETE IN YOUR CLINIC

EVITA TEST COMPLETE is the only NIPT test on the market today, which is based on intact fetal cells and which examines all 23 pairs of chromosomes of the fetus for possible abnormalities. A blood sample from a pregnant woman is analyzed with a patented technology and evaluated by a geneticist in Denmark.

How EVITA TEST COMPLETE works

Step-by-step guide to the EVITA TEST COMPLETE

The EVITA TEST COMPLETE requires a simple 5 step process

1. Receive the test kit

The clinic receives a test kit (EN ISO 13485:2016) that contains everything needed to carry out the blood sampling

2. The blood test is performed

The clinic takes a blood sample from the pregnant woman – 30ml is drawn.

3. Send off the blood sample

The blood sample is sent to ARCEDI, which processes the sample (isolates the fetal cells and prepare fetal DNA for analysis)

4. Genetic analysis

The Clinical Genetics Department at Aarhus University Hospital carries out a genetic analysis and gives the results to the clinic in the form of a short report

5A. A normal result

In the event of a normal test result, the clinic notifies the parent(s) via a phone call, followed by a short report.

5B. A special result

If the test shows a high risk of chromosomal abnormalities in the fetus, the clinic will support the parent(s) by offering an in-depth discussion with a specialized health personnel and advice to attend a consultation and have a placental biopsy or amniotic fluid sample taken in hospital to confirm the finding.

When should the test be undertaken?

An EVITA TEST COMPLETE must be carried out between weeks 10+0 and 14+6. The test results must be sent from the laboratory after no more than 12 working days

Want to know more about NIPT?

EVITA TEST COMPLETE is a cell-based Non-Invasive Prenatal Test. There are several variations of the test 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
  • Examines all fetal chromosomes for genetic defects and disease causing deviations down to 5 million DNA base pairs
  • Can be used by all pregnant women regardless of their own genetics or BMI.

The differences between the various prenatal test types can be seen below.

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.

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, 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.

EVITA TEST COMPLETE screens all fetal chromosomes for the gain or loss of 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  but can still be serious.

For EVITA TEST COMPLETE, any pathogenic (disease causing) copy number variation greater than 5 million DNA base pairs in size will be reported. This could, for example, be:

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

  • Turner’s syndrome
  • XXY – Klinefelters syndrome
  • XYY syndrome

Deletions/duplications* (loss or increase of subsets of a chromosome)

  • Prader Willi syndrome,
  • Angelman syndrome,
  • Cat-eye Syndrome,
  • 1p36 microdeletion syndrome
  • Cat Cry Syndrome

 

* These are examples of deletions or duplications over 5 million DNA base pairs in size, but this is
not a complete list of deletions/duplications that EVITA TEST COMPLETE can detect. Copy number
variations can occur anywhere on the various chromosomes, and EVITA TEST COMPLETE will
report any disease-causing copy number variations over 5 million DNA base pairs in size.

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)

Are you our next clinic partner?

There are already more than 15 clinics that carry out the EVITA TEST COMPLETE in Denmark. 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 61 71 25 57.

Alternatively, you can send us an email at: loha@arcedi.com.

We look forward to hearing from you.