The only reference laboratory in Quebec for the analysis of Harmony® prenatal DNA fetal screening Français
ovo labo, the medical analysis arm of clinique ovo, becomes the first Quebec-based laboratory to offer analysis services for the Harmony prenatal DNA-based test with the construction of two new laboratories in Montreal.
- The construction of the new laboratories responds to a growing demand for prenatal screening.
- The laboratories were built exclusively for the analysis of the Harmony prenatal tests.
- Harmony tests will now be analyzed by a team of accredited experts based in Quebec.
- With an accuracy rate for trisomy 21 detection of over 99.9%,1 the Harmony test is the first prenatal fetal DNA-based test to be approved by Health Canada.
- The Harmony test is used to assess the risk that the fetus may have trisomy 21, 18 and 13 or sex chromosome abnormalities, as well as being used to identify the sex of the fetus.
- Any pregnant woman can undergo a Harmony test, with a doctor's prescription, from the 10th week of pregnancy.
MONTREAL, May 2, 2023 /CNW/ - The clinique ovo is pleased to announce the inauguration of two new laboratories connected to its Montreal clinic, offering pregnant women a new option to access non-invasive Harmony prenatal screening – boasting the highest track record of accurate results in the category2 – and becoming the only laboratory in the province equipped to analyze Harmony in Quebec.
"We are extremely proud to launch these new laboratories in Montreal, joining our network of collection sites across the country, to offer better quality services to expectant mothers during the most important time of their lives, accompanied and supported by our experienced multidisciplinary teams," says Dr. Jacques Kadoch, founding member of the clinique ovo, where he holds the position of Medical Director, and Research Director at The Fertility Partners, the largest consortium of fertility clinics in Canada.
Approved by Health Canada, the Harmony test is a non-invasive prenatal genomic test (NIPT) that analyzes fetal DNA present in maternal blood and determines the likelihood of trisomy 21 (Down syndrome) as well as other common fetal aneuploidies. The test can also be used to identify the sex of the fetus. By offering Harmony test analysis services by experts here in Quebec, reliable results can be provided more quickly to local patients.
The accuracy rate for trisomy 21 detection with Harmony is over 99.9%.3
"It is thanks to this significant investment in both financial and human resources that the construction of these new laboratories has been made possible. Not only can we offer the Harmony screening test, but we can analyze it locally thanks to our specialized multidisciplinary team," concludes Dr. Jacques Kadoch. "My thanks goes to our passionate medical experts, guided by their commitment to excellence and the highest ethical standards, who strive to help women from all over Quebec realize their family dream."
In clinical guidelines published in September 2017, both the Society of Obstetricians and Gynecologists of Canada (SOGC) and the Canadian College of Medical Geneticists (CCMG) agreed that all pregnant women in Canada, regardless of age, should be offered prenatal screening for the most common aneuploidies, as part of routine consultations aimed at informed decision-making.4
In line with these guidelines, Quebec implemented a women's health strategy that includes the Quebec Prenatal Screening Program. This program, offered free of charge in the public health network,5 aims to make prenatal screening for trisomy 21, trisomy 18 and trisomy 13 accessible to pregnant women and couples across the province, but in order for non-invasive prenatal genomic testing to be covered by the Régie de l'assurance maladie du Québec (RAMQ), a pregnant woman must meet certain conditions.6 Screening with the Harmony test through the clinique ovo offers an alternative that complements services offered by the Government of Québec since it provides additional access for future mothers who may not meet these conditions.
More specifically, Harmony is available from the 10th week of pregnancy – earlier than in the public network – for women with a doctor's prescription, who are expecting a child or twins, who have undergone fertility treatment by in vitro fertilization or via the donation of sperm and/or oocytes, and for cases of surrogate pregnancy (surrogate mother). The Harmony test is covered by some private insurance plans and the results, obtained very quickly, provide important information in the early stages of pregnancy.
NOTE: in Quebec, women enjoy freedom of choice. Regardless of their decision following a positive result for trisomy 21, they can still take fill advantage of the advice and services within both the public and private networks to guide them through their journey. At ovo, when a high risk of trisomy 21 is detected following analysis of the Harmony test, the pregnant woman receives care by the clinic's multidisciplinary experts: doctors, geneticists, genetic counselors, clinical biochemists, perinatal counselors, nursing assistants, etc.
- The Quebec Institute of Statistics estimates the number of births in 2022 at 75,000 across the province.7
- The risk of trisomy increases with age. However, young women are not immune to giving birth to a child with Down syndrome.8 9
- While children with trisomy 21 have a higher risk of health problems, it is possible that some children with trisomy 21 have few or no health problems.10
The clinique ovo is a Quebec company that has been working in the field of reproductive and obstetric health for 20 years now. We stand out not only by our expertise, but also by our warm, human and personalized service in all our areas of development. For more information, visit www.cliniqueovo.com.
Approved in 2019 by Health Canada and available in Canada since 2013, HARMONY is a widely prescribed non-invasive prenatal test for pregnant women aged 18 and over, with more than 2.4 million tests performed to date worldwide. More than 268,000 patients are included in 72 peer-reviewed scientific publications,11 including the landmark NEXT study published in the New England Journal of Medicine.12 These studies conclude that the HARMONY test is statistically superior to current practice for first trimester screening for Down syndrome. The Harmony non-invasive prenatal test is based on fetal DNA analysis and is considered a screening test prenatal, not as a diagnostic test. The Harmony test does not screen for possible chromosomal or genetic conditions other than those expressly identified in this document. All women should discuss their results with a healthcare professional, who can recommend diagnostic and confirmatory tests, when appropriate.
® HARMONY is a trademark of Roche. All other product names and trademarks belong to their respective owners.
1Stokowski et al. Prenat Diagn. 2015 Oct; DOI: 10.1002/pd.4686.
2Norton M, et al. N Engl J Med. 2015 Apr 23;372(17):1589-97
3Stokowski et al. Prenat Diagn. 2015 Oct; DOI: 10.1002/pd.4686.
4Audibert F et al. J J Obstet Gynaecol Can. 2017 Sep;39(9):805-817. doi: 10.1016/j.jogc.2017.01.032.
5https://www.quebec.ca/sante/conseils-et-prevention/depistage-et-offre-de-tests-de-porteur/programme-quebecois-de-depistage-prenatal
6https://www.msss.gouv.qc.ca/professionnels/documents/pqdp/Formation_professionnels_COVID19_2020-06-11.pdf
7https://statistique.quebec.ca/fr/produit/tableau/naissances-deces-et-mariages-par-mois-et-par-trimestre-quebec
8https://www.msss.gouv.qc.ca/professionnels/perinatalite/programme-quebecois-de-depistage-prenatal-de-la-trisomie-21/trisomie-21/
9https://www.quebec.ca/sante/conseils-et-prevention/depistage-et-offre-de-tests-de-porteur/programme-quebecois-de-depistage-prenatal
10https://www.msss.gouv.qc.ca/professionnels/perinatalite/programme-quebecois-de-depistage-prenatal-de-la-trisomie-21/trisomie-21
11https://www.rochecanada.com/en/media/roche-canada-news/harmony-test-the-first-non-invasive-prenatal-test-approved-by-health-canada.html/
https://harmonytest.roche.com/global/en/nipt-test-cfdna-clinicians/harmony-difference/the-harmony-nipt-test-cfdna-difference.html
12Norton M, et al. N Engl J Med. 2015 Apr 23;372(17):1589-97 - Harmony test references: https://harmonytest.roche.com/global/en/nipt-test-cfdna-clinicians/harmony-difference/nipt-test-cfdna-references.html
SOURCE Clinique ovo
For more information on the new lab and the Harmony test, please contact: Chloe Plenet, Communications Director, [email protected], 514 798-2000 ext. 108
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