13-11-2017 PRESS RELEASE


– Comparative Non-Invasive Alternative to Invasive “Gold-Standard” Testing –

Vejle, Denmark, November 13, 2017 – ARCEDI Biotech ApS, a company developing technologies for rare fetal cell detection for use in prenatal diagnostic applications, today announced that the Company’s non-invasive prenatal testing technology based on fetal cells enriched from maternal blood will be implemented at hospitals within the Central Denmark region and further holds potential for worldwide implementation. ARCEDI’s cell-based technology provides a viable alternative to existing non-invasive as well as commonly used invasive prenatal testing options including Chorionic Villus Sampling (CVS) and amniocentesis for the detection of aneuploidy and subchromosomal aberrations and abnormalities.

“The gold-standard for prenatal testing is an invasive procedure that poses a potential risk to the fetus,” said Niels Uldbjerg, MD, Consultant and Professor, Department for Women’s Disease and Birth, Aarhus University Hospital. “The only non-invasive alternative we’ve had available until now is cell-free non-invasive prenatal testing (cfNIPT) which currently has a limitation in providing detailed genetic information about the fetus. We are excited that the cell-based non-invasive test has the potential to offer expectant families accurate information only seen through an invasive procedure.”

“The historic launch of ARCEDI Biotech’s cell-based technology in Denmark is a culmination of our commitment to develop a safe, effective, and accurate alternative to existing non-invasive and invasive prenatal testing options,” said Palle Schelde, ARCEDI Biotech’s Chief Executive Officer. “We are excited that the company’s technology is ready for implementation paving the way for commercialization. We hope to work with an established diagnostic company, who recognize the game-changing potential of our technology, to implement into worldwide clinical practice and create a new gold-standard for prenatal testing.”

“The continued validation of our cell-based non-invasive technology is vital as ARCEDI enters into its first launch in Denmark,” added Ripudaman Singh, PhD, MBA, ARCEDI Biotech’s Chief Technology Officer. “In order to evaluate its accuracy, we are currently conducting a validation study where the results obtained from chromosomal microarray (CMA) on fetal cells enriched from maternal blood are compared with CMA on CVS. We will also be performing cfNIPT on the samples to compare the two non-invasive methods for prenatal testing.”

Pregnant women who were determined to have high-risk pregnancies (defined as greater than 1:300) and had already opted to receive invasive prenatal testing were asked to participate in the validation study. In the study, 30 mL of blood was drawn from participants during gestational ages of 10-13 weeks. Fetal trophoblast cells were enriched using proprietary antibodies on a magnetic activated cell sorting (MACS) system and subsequently stained with a cocktail of fluorescent antibodies. Fetal cell DNA was whole genome amplified and subsequently analyzed by CMA.

“The results from the validation study thus far are promising,” said Dr. Ida Vogel, Consultant, Department of Clinical Genetics and Centre for Prenatal Diagnostics, Aarhus University Hospital. “It is truly ground breaking that cell-based testing may be able to identify not only chromosomal aneuploidies, but also smaller aberrations, such as microduplication and translocation, that currently can only be viewed through CVS and other invasive procedures.”

Prior to the validation study and launch, ARCEDI has reported the steps taken to establish fetal gene expression profiles and generate knowledge of the type of fetal cells circulating in maternal blood as well as the biomarkers they express. Initially, fetal cells were isolated using either a no-enrichment method or through the depletion of maternal leucocytes using a MACS platform. Once assessed, these cells showed an over-expression of endothelial and placental genes in fetal cells compared to the maternal cells.

A second, more targeted gene expression array analysis of 198 circulating fetal cells was then completed which revealed that more than half of the overexpressed genes in the fetal cells were specific in extravillous trophoblasts (EVTs). This provided ARCEDI with the cell type to target for cell-based testing.

About ARCEDI Biotech

ARCEDI Biotech, a Danish biotech company, 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.


Cooper Zajac
Argot Partners
(212) 600-1902