- Simple, Non-Invasive Blood Test Poses No Risk to Pregnant Woman and Fetus; Significantly Safer, More Comprehensive and More Inclusive Compared to Invasive Tissue Sampling Test
- Intended for All Pregnant Women, Not Just High-Risk Categories, at 10-14 Weeks of Pregnancy; Earlier Administration Potentially Leading to Higher Confidence and More Individualized Care
- Achievement Follows ARCEDI's Prior Non-Invasive Pregnancy Testing Innovations, Including Being the First Company to Identify Extravillous Trophoblasts as the Fetal Cell Types Circulating Within the Maternal Bloodstream
Vejle /PRNewswire/ - ARCEDI Biotech ApS, a company developing technologies for rare fetal cell detection for use in prenatal diagnostic applications, 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 overview of all 22 chromosome pairs and sex chromosomes of the fetus to identify the presence of a number of serious chromosome abnormalities that can cause syndromes, and it can also identify the sex of the baby from as early as week 12 of pregnancy. EVITA, developed through a 16-year-long public-private research collaboration with Denmark-based Aarhus University Hospital, is intended for use by all pregnant women via a simple blood-draw, not just women who fall into high-risk categories like with currently available gold-standard tests. EVITA will first become available to private fertility clinics in Denmark, beginning with the AAGAARD Fertility Clinic, Aarhus (a member of Virtus Health) on April 6, 2021.
"Launching the EVITA test is a significant milestone in our journey to create simpler, safer and more accurate non-invasive prenatal diagnostic testing (NIPT) so that all pregnant women have the opportunity to get a comprehensive genetic overview of the growing fetus without any risk to the mother or fetus," says Palle Schelde, Chief Executive Officer, ARCEDI Biotech. "I am grateful for the deep scientific collaboration and commitment to expectant mothers our team and partners exhibited that led to the creation of the EVITA test and the possibility of more confident pregnancies."
All women, between 10-14 weeks of their pregnancy, can take the EVITA test via a simple blood draw with no risk to themselves or the fetus. EVITA detects, identifies and isolates fetal cells in the mother's blood and uses DNA of cells to give a comprehensive genetic overview of the fetus. The test analyzes for serious chromosome defects that can cause common syndromes, such as Down syndrome, Edwards syndrome and Patau syndrome. Less frequent syndromes that can lead to genetic impairment and cause significant life-long impacts for the child are also detected.
After the test is conducted, geneticists analyze the fetal cells and a medical professional then follows up with pregnant women whose test results show chromosome aberrations. The result of the EVITA test is combined with an individual medical expert assessment of whether there are significant chromosome abnormalities. When deviations are detected that require extra attention, the pregnant woman is offered an interview with a doctor with expert knowledge of clinical genetics to discuss the outcome and next steps.
"The EVITA test is a groundbreaking and critical offering to the growing number of families that want to know the genetics of their unborn child in a manner that is completely safe for the pregnant mother and fetus, with no risk of miscarriage," says Johnny Hindkjær, Scientific Director and Laboratory Manager at the AAGAARD Fertility Clinic. "We are proud to be the first clinic worldwide to implement use of this testing option to all of our current and future patients. We are eager to begin testing with ARCEDI Biotech's EVITA test, as we expect high demand and want to help expectant mothers feel more informed during what can be a stressful time."
EVITA was designed as a safe alternative to invasive placenta tissue sampling [chorionic villus sampling (CVS)], the standard for many years, which requires the insertion of a long needle and can result in involuntary miscarriages in up to 0.5 percent of tested women. Additionally, the EVITA test will help to expand the number of pregnant women who can undergo prenatal genetic testing because all women, not just those who are considered high-risk, can take it. 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 approximately 1,800 pregnant women in this high-risk group receive a chorionic villus sampling (CVS) or a cell-free non-invasive prenatal testing (NIPT) test, a blood test which analyzes five chromosomes.
To date, OB/GYNs have been limited to either invasive testing options, such as CVS and amniocentesis, or NIPT, that are focused on the use of free floating fetal-DNA within the maternal blood, which do not allow medical professionals to fully micro-analyze the genetics of a fetus. Using the technology behind EVITA TEST COMPLETE, fetal cells go through whole genome amplification, which allows for a full genome analysis to determine a greater number of abnormalities without using invasive methods which have been known to cause miscarriages and fetal damage, including the gold-standards, CVS and amniocentesis.
ARCEDI is preparing to introduce the EVITA TEST COMPLETE to several other IVF clinics in Denmark during the fall of 2021. The Company also plans to engage regulatory authorities, potential future commercialization partners and potential future investors in the US, UK and EU in 2021 to accelerate global roll out and expansion in those markets.
About EVITA TEST COMPLETE™
The EVITA TEST COMPLETE™ (EVITA) is the first and only maternal blood test based on fetal cells on the market that examines every chromosome of the fetus and highlights any significant aberrations (gains and losses). The test reveals numerical aberrations and detects microdeletions and microduplications down to a size of five megabases. The chromosomal aberrations that are detected can cause syndromes such as Down syndrome, as well as a series of other lesser-known genetic syndromes that could lead to health complications later in life.
With ARCEDI's approach to chromosome testing, a medical expert evaluates each sample and determines whether there are any significant chromosomal and clinically relevant aberrations. EVITA can also identify the sex of the baby from as early as week 12 of pregnancy.
About ARCEDI Biotech
ARCEDI Biotech, established in 2005, is a Danish biotech company which has developed technology to isolate fetal cells from maternal blood samples with the potential to provide detailed genetic information about the fetus. The company's internal testing to date has identified fetal cells in every sample, a significant advancement over currently available technology. ARCEDI is currently performing a clinical validation study on 'high risk' pregnancies which will enable a comparison of results from cell-based analysis with the results from cell-free NIPT and CVS. ARCEDI is also researching the potential utility of its rare cell isolation technology in the early detection of trophoblastic diseases. For more information, please visit www.arcedi.com.