Chromosome test of the fetus - completely risk-free with blood test

Press release
6.4. 2021

Danish biotech company: 
Launch of pioneering blood test with genetic profile of the fetus

The Danish biotech company, Arcedi Biotech, announces the launch of Evita test completeTM, a technology that will revolutionize the choices available for pregnant women who want to get a clear genetic overview of their unborn child. The test looks for serious chromosomal aberrations – using nothing else than a blood sample. 

Most women agree that a needle prick is much more tolerable than a needle inserted through the stomach when it comes to prenatal diagnostic testing. And for this very reason, the Danish biotech company, Arcedi Biotech, expects to attract considerable international interest and high demand for the new test announced by the company today.  

For the first time in history, pregnant women and their families can get a genetic profile of all 22 chromosome pairs and sex chromosomes of the fetus. It is a giant leap forward in health technology because the test is based on a simple blood draw from the mother and therefore poses no risk whatsoever to the fetus. 

Peace of mind in pregnancy
“Our aim is for the test to give peace of mind in pregnancy. It is the result of 16 years of public-private research collaboration. It’s the story of high-level scientific research, passionate enthusiasts, thousands of hours looking through the microscope, and patient capital,” says Palle Schelde, Chief Executive Officer of Arcedi Biotech and one of the researchers on board from the start.

Commenting on the public-private collaboration and the resulting test, Ida Vogel, Clinical Professor in Prenatal Diagnostic Testing at Aarhus University and Aarhus University Hospital, says: “Throughout our research collaboration, we have been driven by a strong, common wish to revolutionize prenatal diagnostic testing. Together we have reached a significant milestone and have laid the foundation to deliver a series of important results in future.” 

Placenta tissue sampling (chorionic villus sampling, CVS)
Chorionic villus sampling (CVS) has been the standard for many years, and despite the relatively low risk of miscarriage, prenatal diagnostic testing is exactly what many pregnant women fear. Evita test completeTM could become an alternative to chorionic villus sampling (CVS). The test identifies a number of chromosomal aberrations which today can only be found by taking a sample of tissue from the placenta. Chromosomal aberrations can cause syndromes such as Down's syndrome, Edwards syndrome, Patau syndrome, and a series of other genetic conditions that could have serious consequences for the child later in life. 

To begin with, the test will be offered to pregnant women against payment. The Aagaard Clinic in Aarhus will be the first clinic offering the test in Denmark. Here, all women – regardless of whether they are in a high-risk group  or patients at the clinic – can buy the test if they want to know the genetic profile or any chromosomal aberrations of their unborn child. 

”The test is a unique and groundbreaking offer for the growing number of families wanting to know the genetics of their unborn child. It gives peace of mind in pregnancy, and we expect high demand for the test, because all women – with no risk of miscarriage – can be informed of the child’s chromosomes,” says Johnny Hindkjær, Scientific Director at the Aagaard Clinic. 

Identification of fetal cells in maternal blood
Evita test completeTM is based on years of work to identify and isolate fetal cells in maternal blood – and use the DNA of the cells to give a clear genetic overview of the fetus. Many told us that it wasn’t possible, but we succeeded, and are now able to launch the test thanks to our team of about 25 researchers. 

The scientific work began more than 20 years ago when a research team – headed by the late Professor Steen Kølvraa – committed itself to crack the code to identify and isolate fetal cells in maternal blood. 
Read the story of how the research efforts began 

The future 
”The public-private collaboration is a success, and it is the focal point of our future business. Geneticists at Aarhus University Hospital analyze the fetal cells in the blood sample, and the public health services follow up with the pregnant woman in case chromosomal aberrations are detected. In capacity as private company, we offer technology and expert knowledge and a ready-made concept that can ensure a global rollout of the test. It’s a strong match,” says Palle Schelde. 

Our ambition is to make the test widely available through several fertility clinics, starting with Denmark and moving on to Europe and the USA.

Further information: 
Palle Schelde, Chief Executive Officer, Arcedi Biotech, tel: +45 29 64 15 45, email: ps@arcedi.com. Read more about Evita test completeTM (www.evitatest.com )

Facts:
Pregnancies:
•    60,000 annual births in Denmark.
•    97 percent of pregnancies are characterized as normal.
•    In 3 percent of pregnancies, the fetus has one or several genetic deviations.  
About Evita test completeTM 
•    Evita test completeTM is the first blood sample test in the world that gives a complete overview of all of the child’s chromosomes (22 chromosome pairs + 2 sex chromosomes). 
•    The test costs DKK 12,000 and is taken at weeks 10-14 of pregnancy.
•    Evita test completeTM is combined with an individual medical expert assessment of whether there are significant chromosome aberrations.  
•    If deviations requiring extra attention are detected, the pregnant woman is offered an interview with a doctor with expert knowledge of clinical genetics to discuss the outcome and next steps. 
•    The test looks for serious chromosomal aberrations that can cause syndromes such as Down's syndrome, Edwards syndrome, Patau syndrome, and serious chromosomal aberrations that could have serious complications for the child later in life.
 
Present offer to pregnant women:
•    Every year, an estimated 1,800 women in Denmark are in a high-risk group. Today, they are offered a chorionic villus sampling (CVS) or cell-free NIPT test (a blood sample, which provides answers to five chromosome pairs). 
About Arcedi Biotech (www.arcedi.com ):
•    ARCEDI Biotech is a Danish biotech company which is built on a public-private collaboration based on a common interest in genetic mapping of the fetus.
•    The company is headquartered at Aarhus University Hospital and consists of a team of about 25 researchers and highly specialized staff.
•    The Bagger-Sørensen family has served as partner in the company since 2013.