Evita Test Complete

Please note that rescan/resampling is not possible December 18th till January 1st (both days included)

From week 10+0-14-6

Up to 30 minutes

Price: DKK 14500,- (Not eligible for discount).* 

If you have the test done after 11 AM it will get sent to the lab the following day.

Please note: Can be done on Monday-Thursday only. It isn’t possible to book Evita online – you need to call or write us.

Try our guide to see which NIPT test is right for you here.

In addition, cell-based NIPT can detect deletions and duplications, which are small losses or extra copies of subsets of chromosomes. This can lead to various syndromes, including:

• 1p36 deletion:
  • Can cause heart malformations, seizures and developmental delays.
• Wolf-Hirschhorn syndrome:
  • Caused by deletions on chromosome 4, resulting in striking facial features, growth retardation, developmental disabilities and epilepsy.
• Cri-du-chat syndrome:
  • Caused by a deletion on chromosome 5 and is named because of characteristic crying sounds. It causes severe developmental disabilities.
• Williams syndrome:
  • Caused by a deletion on chromosome 7 and is characterized by developmental delay, risk of heart defects and significant growth problems.
• Prader-Willi and Angelman syndromes:
  • The test can detect these syndromes, which are caused by deletions on chromosome 15. Prader-Willi causes early significant growth problems and later obesity and developmental disability. Angelman causes developmental disabilities, learning disabilities, lack of language and characteristic movement disorders.
• 22q11 deletion syndrome:
  • Can cause heart defects, immune problems and developmental delay in particular.

The above areas are reviewed with special attention due to their frequency. It is because of their frequency that the syndromes have been given names.

However, one of the great advantages of cell-based NIPT is that it examines the entire genomic material and not just a limited list of syndromes. It can identify significant deletions down to 2 million base pairs (>2 Mb) and duplications down to 5 million base pairs (>5 Mb) across the entire genome. This means that EVITA TEST COMPLETE can also find syndromes that have not yet been named. In comparison, similar tests on the market can only go down to about 7 Mb.

EVITA TEST COMPLETE is first-movers on a patented technology that is constantly evolving and the method is still being developed and improved. Our goal is to be as precise as a placenta biopsy.

Since EVITA TEST COMPLETE examines whole, isolated fetal cells, it is free from the influence of the pregnant woman’s DNA and her BMI or any cancers. This is an issue with other cf-NIPTs on the market and can lead to a high risk of false-positive results.

It is important to note that although the EVITA TEST COMPLETE is a detailed method, it is a screening method. This means that a non-normal result should always be followed up with a placenta sample.

EVITA TEST COMPLETE is the only privately offered NIPT test where all processes from blood sample to result report take place in Denmark and where you as a customer have the opportunity to contact the company behind and get answers to all your questions and the test is therefore also covered by Danish law and GDPR.

How does an EVITA TEST COMPLETE work?

A blood sample is taken, which is analyzed with special technology and assessed by a specialist geneticist. Within 12 business days after the blood sample is taken, you will receive a response. In this response, it is also possible for you to find out the sex of the baby at no extra cost. The test can be taken at gestational age 10+0 and 14+6.

As fetal cells in the pregnant woman’s blood are extremely rare, in a small number of samples (6%) there may not be enough fetal cells in the blood sample to perform the chromosome study. In these cases, you will be offered a new blood sample (free of charge and only within gestational age 10+0-14+6), after which the number of samples for which chromosome analysis of the fetus cannot be completed drops to only 2%.

EVITA TEST COMPLETE’s analysis method

ARCEDI Biotech previously analyzed DNA from fetal cells using a technology called microarray, but on August 15th 2024 we switched to analyzing DNA from fetal cells using sequencing (WGS)

WGS stands for “Whole Genome Sequencing.” It is a technology used to read the entire genom.

Microarray analysis is limited to predefined probes, while whole genome sequencing analyzes the entire genome.

The test takes 30 minutes and always includes a scan, a print with the scan results, one color photo of your baby and all the images and clips from the scan in Tricefy. You can buy extra color photos at the price of dkk 20/pc. It depends on the fetus’s age what we can see in the scan.

In case the NIPT test cannot be performed due to fetal issues, or if you change your mind after receiving counseling, and before your consultation is over, you will get charged for an Early Scan (not eligible for discount).

If your test come back with insufficient amount of whole cells we offer a redraw for free. If the second round shows insufficient material we consider it not possible to go through with the test and you will get a refund.

You are a candidate for Evita if:

• You are between pregnancy weeks 10+0 and 14+6 weeks
• You are expecting singleton
• You have had a previous pregnancy with chromosome anomalies
• You are not comfortable with the 12 week risk assessment
• You have received fertility treatment, egg donation or have experienced miscarriages
• There are contraindications to CVS or AC such as placenta previa or increased risk of miscarriage
• You just want the extra security

You are not a candidate for the test if:

• You are less than 10+0 or more than 14+6 weeks pregnant
• You have experienced “vanishing twin”
• You are expecting twins or more

EVITA TEST COMPLETE is not yet validated for

– 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 all chromosomes)
– Balanced translocations (swapping of chromosome material between two different chromosomes, but the total amount of       chromosomes is unchanged)
– Uniparental disomy (UPD) (two copies of a chromosome are inherited from only one parent)

EVITA TEST COMPLETE is clinically validated in Denmark

EVITA TEST COMPLETE, also known as cell-based NIPT (cbNIPT), was developed together with researchers from Aarhus University Hospital and has been running as a clinical validation study in the Central Denmark Region in 2018-2023 on 344 women. The results have been published in the journal Prenatal Diagnosis.

 

 

If you need more information you are very welcome to contact us. Either way you will receive counselling prior to the test when you arrive at the clinic.

Glossary:

• Aneuploidy: An aberration in the chromosome set (karyotype) in the form of too many or too few chromosomes. Normally we have 46 chromosomes in our cells – 23 from the mother and 23 from the father. These are arranged in pairs. The chromosomes consist of DNA and determine – among other things – our appearance and gender (XX for girl and XY for boy). In aneuploidies, the number of chromosomes is altered (e.g. 45 or 47). The consequence of the aneuploidy depends on which chromosome pair is affected. Examples of aneuploidies are Down’s Syndrome and Turner’s Syndrome.
• Trisomy 21, Down’s Syndrome – an additional chromosome 21, i.e. 3 where there should have been 2 (tri = 3). One of the most common forms of developmental impairment.
• Trisomy 18, Edward’s syndrome – an additional 18th chromosome. Malformations and severe mental retardation. Short lifespan. Rare.
• Trisomy 13, Pataus syndrome – an additional 13th chromosome. Malformations and severe mental retardation. Short lifespan. Rare.
• Turner’s Syndrome – missing or altered sex chromosome (X) in girls.
• Microdeletions – Microdeletions are caused when a chromosome is missing a small piece. The severity of problems caused by a microdeletion is determined primarily by the size and location of the deletion.
• Microduplications – Microduplications are caused by the copying of a small piece of a chromosome in each cell. Can cause autism spectrum disorders, learning disabilities, heart defects and other anomalies.
• Placenta biopsy (Chorion Villus Sample (CVS)* – invasive test where small pieces of the placenta are retrieved through a thin needle in the mother’s abdomen for chromosome analysis. Possible from week 10.
• Amniocentesis (AC)* – invasive test where amniotic fluid is retrieved through a thin needle in the mother’s abdomen for chromosome analysis. Possible from week 16.

*Invasive diagnostic tests are not performed at Spire. It is your own responsibility to take your results to the relevant health care center if needed – but we are happy to help you along in this process!

*Prices are subject to change