Simple, non-invasive blood test poses no risk to the pregnant woman or the fetus; significantly safer, more comprehensive and more meaningful compared to the invasive test with tissue samples
Intended for all pregnant women, not just for high risk categories, in the 10th to 14th week of pregnancy; earlier administration may lead to increased confidence and more personalized care
Success follows previous non-invasive pregnancy testing innovations from ARCEDI, including being the first to identify extravillous trophoblasts as the fetal cell types circulating in the maternal bloodstream
VEJLE, Denmark, 7. April 2021 / PRNewswire / – ARCEDI Biotech ApS, a company developing technologies to detect rare fetal cells for use in prenatal diagnostics, today announced the launch of EVITA TEST COMPLETE ?? (EVITA), the first prenatal genetic blood test to identify and isolate fetal cells in maternal blood. EVITA provides a complete look at all 22 pairs of chromosomes and sex chromosomes in the fetus to help identify the presence of a number of serious chromosomal abnormalities that can cause syndromes, and it can also determine the baby’s sex from as early as 12 weeks of gestation. EVITA was established in a 16-year public-private research collaboration with the Danish university hospital Aarhus and is intended for use by all pregnant women via a simple blood draw, not just women who fall into high risk categories such as the gold standard tests currently available. EVITA will initially be available to private fertility clinics in Denmark, starting with the AAGAARD fertility clinic, Aarhus (a member of Virtus Health) on 6. April 2021.
The launch of the EVITA test marks a significant milestone in our journey to develop simpler, safer and more accurate non-invasive prenatal diagnostic tests (NIPT) so that all pregnant women have the opportunity to have a comprehensive genetic overview of the growing fetus without putting the mother or fetus at risk, “says Palle Schelde, Chief Executive Officer, ARCEDI Biotech. ?? I am grateful for the intensive scientific collaboration and commitment to expectant mothers that our team and partners have shown and that has led to the development of the EVITA test and the possibility of safer pregnancies. “
All women between 10-14 weeks of pregnancy can take the EVITA test with a simple blood sample without any risk to themselves or the fetus. EVITA detects, identifies and isolates fetal cells in the mother’s blood and uses the cells’ DNA to provide a comprehensive genetic overview of the fetus. The test analyzes for severe chromosome defects that can cause common syndromes such as Down syndrome, Edwards syndrome, and Patau syndrome. Less common syndromes that can lead to genetic impairment and have significant lifelong effects on the child are also recognized.
After the test is done, geneticists analyze the fetal cells and a medical professional then follows up with pregnant women whose test results show chromosomal aberrations. The result of the EVITA test is combined with an individual medical expert assessment of whether there are significant chromosomal abnormalities. If deviations are found that require special attention, the pregnant woman will be offered a consultation with a doctor who is knowledgeable in clinical genetics to discuss the outcome and next steps.
The EVITA test is a breakthrough and critical offering for the growing number of families who want to learn about the genetics of their unborn child in a way that is completely safe for the pregnant mother and fetus, without the risk of miscarriage “says Johnny Hindkjær, Scientific Director and Laboratory Manager of AAGAARD Fertility Clinic.” We are proud to be the first clinic in the world to introduce the use of this testing option for all of our current and future patients. We look forward to working with the EVITA -Test by ARCEDI Biotech to begin as we expect high demand and want to help expectant mothers to feel better informed during this often stressful time. “
EVITA was proposed as a safe alternative to invasive placental tissue harvesting [Chorionzottenbiopsie (CVS)] developed, the long-standing standard that requires the insertion of a long needle and can lead to unwanted miscarriages in up to 0.5 percent of the women tested. In addition, the EVITA test will help expand the number of pregnant women who can undergo prenatal genetic testing because all women, not just those who are considered to be high risk, can take the test. Currently, of the 60,000 births per year in Denmark, three percent of pregnancies have fetuses with one or more genetic defects, which means that around 1,800 pregnant women in this high-risk group received a chorionic villus sampling (CVS) or a cell-free non-invasive prenatal test (NIPT), a blood test that analyzes five chromosomes.
Up until now, OB / GYNs have been limited to either invasive testing options like CVS and amniotic fluid testing or NIPT, which focus on the use of free-floating fetal DNA in maternal blood that does not allow medical professionals to fully micro-analyze the genetics of a fetus. With EVITA TEST COMPLETE’s technology, fetal cells are subjected to whole genome amplification, which allows full genomic analysis to identify a greater number of abnormalities without using invasive methods known to cause miscarriage and fetal damage, including gold standards CVS and amniocentesis.
ARCEDI is preparing to launch the EVITA TEST COMPLETE in several other IVF clinics in Denmark in autumn 2021. The company also plans to meet with regulatory agencies, potential future commercialization partners, and potential future investors in the in 2021 USATo liaise with the UK and the EU to accelerate global rollout and expansion in these markets.
Information on EVITA TEST COMPLETE ??
The EVITA TEST COMPLETE ?? (EVITA) is the first and only maternal fetal cell-based blood test on the market that examines every chromosome in the fetus and highlights significant aberrations (gains and losses). The test reveals numerical aberrations and detects microdeletions and microduplications up to a size of five megabases. The chromosomal aberrations discovered can cause syndromes such as Down syndrome, as well as a number of other lesser-known genetic syndromes, which can lead to health complications later in life.
In the ARCEDI approach to chromosome testing, a medical professional evaluates each sample and determines whether there are significant chromosomal and clinically relevant aberrations. EVITA can also determine the sex of the baby from the 12th week of pregnancy.
Information on ARCEDI Biotech
ARCEDI Biotech, founded 2005, is a Danish biotech company that has developed a technology to isolate fetal cells from maternal blood samples that can provide detailed genetic information about the fetus. The company’s internal testing to date has identified fetal cells in every sample, a significant advance over currently available technology. ARCEDI is currently conducting a clinical validation study in “high risk” pregnancies that will enable the results of cell-based analysis to be compared with those of cell-free NIPT and CVS. ARCEDI is also exploring the potential utility of its rare cell isolation technology for the early detection of trophoblastic diseases Diseases, please visit www.arcedi.com for more information.
Media contact in the company:
Herr Palle Schelde, CEO
Tel.: +45 2964 1545
Email: [email protected]
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