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News

Ariosa Diagnostics, CHU de Quebec and Genome Canada launch study of non-invasive prenatal testing in Canada

Genome Canada : 14 August, 2013  (Company News)
A team of researchers led by CHU de Quebec and Universite Laval, has received CAN$10.5 million from Genome Canada, the Canadian Institutes of Health Research (CIHR), Genome Quebec and other partners to conduct a large-scale comparative effectiveness study on non-invasive prenatal screening techniques.


Dr Francois Rousseau and his team will examine current prenatal screening practices for chromosomal conditions, such as Down syndrome, among pregnant women in Canada in order to improve screening approaches and avoid unnecessary procedures.



Each year in Canada, about 450,000 women become pregnant and are offered Down syndrome prenatal screening using biochemical and ultrasound markers. The vast majority will be negative or low risk. However, for positive or high-risk results, those pregnant women are referred to amniocentesis, which is an invasive procedure done to confirm the screening result. Approximately five percent of all biochemical screening results are falsely positive, attributing to unnecessary invasive procedures that pose a 1 in 300 risk for miscarriage.



Genome Quebec is a strong supporter of public-private partnerships, such as the one developed between Ariosa Diagnostics and Dr Francois Rousseau's team. The PEGASUS: PErsonalized Genomics for prenatal Aneuploidy Screening USing maternal blood project, made possible through such partnerships in personalized medicine, will help meet women's healthcare needs by giving them access to safer prenatal screening tests, explains Marc LePage, Genome Quebec's President and Chief Executive Officer.



The research project aims at independently comparing the performances of different such approaches that involve various combinations of the available tools for screening of chromosomal conditions, as well as to evaluate the cost-effectiveness, the ethical and social aspects of this new technology and to identify and adapt the best implementation tools for users in the health care system. The researchers will recruit 5600 pregnant women (3600 at high-risk of trisomy conditions and 2000 at low-risk). Samples from these women will be tested in parallel using different screening approaches that involve genomic-based NIPT, but also existing or new biochemical and ultrasound screening tools. The samples will be analyzed without knowledge of the true status of the pregnancy outcome. This will provide a comprehensive evaluation of the most efficient ways to improve the prenatal screening techniques widely used today.



Ariosa Diagnostics is one of the major commercial partners for this project and will provide testing for part of this large sample that will include mainly low-risk women. The investigators have chosen the Harmony Prenatal Test as the commercially available NIPT assay to be included as one the various screening tests that will be compared.



Dr Rousseau, Leader of the Project, mentioned: "We are happy that Ariosa Diagnostics has joined this effort and provided a significant contribution to this Project. Ariosa's Harmony test is the most affordable commercial NIPT available, and it was chosen by the research team for this study because it is the most likely to be used in the Canadian context."



Dr Thomas Musci, Vice President of Clinical and Medical Affairs at Ariosa remarked: "Ariosa, as a core corporate value, is committed to furthering rigorous clinical and scientific study of cell-free DNA technology and the Harmony Prenatal Test in a variety of clinical settings and in a number of different countries. We are extremely pleased to support this collaboration with Genome Canada and fully support the goals of their research efforts."



Dr Serge Rivest, Director of the research Centre at the CHU de Qudbec, said: "The leadership of the researchers from CHU de Quebec Research Center was key in putting this exceptional academic team together to tackle one of the hottest clinical application of next-generation sequencing in the context of a population-based screening programme."


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