Pregnant women could soon be able to rely on the first Canadian-licensed non-invasive prenatal test
Canada NewsWire
LAVAL, QC, June 27, 2018
Trusted and Proven Harmony™ Test is seeking Health Canada Approval
- Class III* medical device license application submitted by Roche Diagnostics Canada
- Available in 100 countries with 1.4 million tests done to date
- 148,000 patients included in 48 peer-reviewed publications
LAVAL, QC, June 27, 2018 /CNW Telbec/ - With several provinces considering non-invasive prenatal testing as an addition or expansion to their prenatal screening programs (for trisomy 21, 13 and 18), Roche Diagnostics, division of Hoffmann-La Roche Limited, has formally asked Health Canada to review its trusted and proven Harmony test. In submitting a Class III medical device license application to Health Canada, the goal is for the Harmony test to obtain a conformity assessment by the federal regulatory body in terms of safety, effectiveness and quality.
With a license that could be granted in the coming months for Harmony, pregnant Canadian women would benefit from the first Health Canada-approved non-invasive prenatal test. In Europe, Harmony was the first prenatal test to receive, in 2016, the CE Marking designation (indication of conformity with health and safety standards for products sold within the European Economic Area.)i
As early as 10 weeks of pregnancy for women of all ages
Prenatal guidelines of the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the Canadian College of Medical Geneticists (CCMG) recommend that "all pregnant women in Canada, regardless of age, should be offered the option of a first trimester ultrasound and a prenatal screening test for the most common fetal aneuploidies (e.g., Down syndrome) and major congenital anomalies". ii
Harmony is a blood screening test for pregnant women that can be used as early as 10 weeks of pregnancy. By evaluating fetal DNA found in maternal blood, the test assesses the probability of trisomy 21 (Down syndrome) and other common fetal aneuploidies. It is proven to detect >99% of cases of trisomy 21, 97.4% of cases of trisomy 18 and 93.8% of cases of trisomy 13, with a rate of false positives of less than 0.1%. iii
Reimbursement
To date, non-invasive prenatal screening tests such as Harmony are reimbursed under certain conditions in Ontario (since 2015), British Columbia (since 2016) and Yukon (since 2017). In addition, the Quebec Government announced last April that in the year to come it will proceed with the public funding of such a test for pregnancies deemed high risk.
About the Harmony Non-Invasive Prenatal Test
Harmony is a widely prescribed non-invasive prenatal test among pregnant women of all ages with more than 1.4 million tests performed worldwide. Over 148,000 patients have been included in 48 peer-reviewed publications regarding the Harmony test iv, including the landmark NEXT study v published in The New England Journal of Medicine, and the PEGASUS vi study performed recently in Canada . These studies show that Harmony was statistically superior to the existing first-trimester screening practice for the detection of trisomy 21 in a general pregnancy population.
Harmony test results are intended for prenatal screening and are not intended to be the sole basis for diagnosis. Expectant parents should discuss positive results with their physician, who can recommend confirmatory testing when appropriate.
The Harmony Prenatal Test was developed by Ariosa Diagnostics, a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited clinical laboratory in San Jose, CA, USA.
About the Roche Group
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
HARMONY PRENATAL TEST and HARMONY are trademarks or registered trademarks of Ariosa Diagnostics, Inc. in the U.S.A. and other countries.
Non-Invasive Prenatal Testing (NIPT) based on fetal cell-free DNA analysis is not a diagnostic test. No irrevocable obstetrical decision should be made on a positive result generated from a Non-Invasive Prenatal Testing (NIPT) based on fetal cell-free DNA analysis, without confirmation by other invasive diagnostic testing. As of today, the test is not for sale as an In Vitro Diagnostic test in Canada.
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References | ||
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* All in vitro diagnostic instruments (IVDI) that Roche plans to market in Canada require registration with Health Canada. The classification (I, II, III or IV) of a registration is based on the risk of the IVDI. The higher the risk, the higher the classification is required. | ||
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IVDI in Class III are those whose use poses a moderate risk to public health or a high risk to the person. Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs): https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html | ||
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i |
Roche (2016), "Harmony® Prenatal Test for assessment of Down syndrome and other chromosomal disorders receives CE mark", https://www.prnewswire.com/news-releases/harmony-prenatal-test-for-assessment-of-down-syndrome-and-other-chromosomal-disorders-receives-ce-mark-300336275.html | |
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ii |
SOGC (2017), "Guideline Provides Maternity Care Providers with New Tools for Prenatal Screening and Testing", https://sogc.org/files/medPrenatalTestingweb.pdf. | |
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iii |
1.Norton et al. N Engl J Med. 2015 Apr 23;372(17):1589-97. 2. Norton et al. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8. 3.Ashoor et al. Ultrasound Obstet Gynecol. 2013 Jan;41(1):21-5. 4. Sparks et al. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9. 5.Verweij et al. Prenat Diagn. 2013 Oct;33(10):996-1001. 6. Nicolaides et al. Am J Obstet Gynecol. 2012 Nov;207(5):374.e1-6. 7. Ashoor et al. Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5. 8. Gil et al. Fetal Diagn Ther. 2014;35:204-11. 9. Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6. 10. Stokowski et al. Prenat Diagn. 2015 Oct; DOI: 10.1002/pd.4686. 11. Data on file with the manufacturer. | |
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iv |
1. Ashoor G et al. Fetal Diagn Ther. 2012;31(4):237-43. | |
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2. Ashoor G et al. Am J Obstet Gynecol. 2012;206(4):322.e1-5. | ||
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3. Nicolaides KH et al. Am J Obstet Gynecol. 2012;207(5):374 e1-6. | ||
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4. Norton ME et al. Am J Obstet Gynecol. 2012;207(2):137.e1--8. | ||
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5. Sparks et al. Am J Obstet Gynecol. 2012;206(4):319e1-9. | ||
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6. Sparks et al. Prenat Diagn. 2012;32(1):3-9. | ||
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7. Ashoor G et al. Ultrasound Obstet Gynecol. 2013;41(1):21-25. | ||
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8. Ashoor et al. Ultrasound Obstet Gynecol. 2013;41(1):26-32. | ||
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9. Brar et al. J Matern Fetal Neonatal Med. 2013;26(2)-143-45. | ||
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10. Fairbrother et al. Prenat Diagn. 2013: March 1-5. | ||
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11. Gil MM et al. Ultrasound Obstet Gynecol. 2013;42(1):34-40. | ||
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13. Wang et al. Prenat Diagn. 2013;33(7):662-6. | ||
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14. Gil MM et al. Fetal Diagn Ther. 2014;35(3):204-211. | ||
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15. Feenstra et al. Prenat Diagn. 2014;34(2):195-8. | ||
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16. Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6. | ||
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18. Nicolaides KH et al. Fetal Diagn Ther. 2014;35(1):1-6. | ||
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19. Struble et al. Fetal Diagn Ther. 2013;35(3):199-203. | ||
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20. Willems et al. Facts View Vis Obgyn. 2014;6(1):7-12. | ||
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21. Wallerstein et al. J Pregnancy 2014 | ||
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25. Hernández-Gómez et al. Ginecol Obstet Mex. 2015;83(5):277-288. | ||
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26. Norton ME et al. N Engl J Med. 2015;372(17):1589-1597. | ||
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29. Stokowski et al. Prenat Diagn. 2015;35(12):1243-1246. | ||
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30. Chen et al. Prenat Diagn. 2016;36(13):1217-1224. | ||
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31. Gil MM et al. Ultrasound Obstet Gynecol. 2016;47(1):45-52. | ||
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32. Gil MM et al. J Matern Neontal Med. 2016:November 1-7. | ||
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33. Kagan et al. Arch Gynecol Obstet. 2016;294(2):219-224. | ||
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34. McLennan et al. Aust NZ J Obstet Gynaecol. 2016;56(1):22-28. | ||
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36. Sarno et al. Ultrasound Obstet Gynecol. 2016;47(6):705-711. | ||
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37. Bevilacqua et al. Fetal Diagn Ther. 2017 Aug 23. | ||
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38. Bjerregaard et al. Dan Med J. 2017 Apr;64(4).pii: A5359. | ||
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39. Chan et al. BJOG An Int J Obstet Gynaecol 2017 | ||
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40. Jones et al. Ultrasound Obstet Gynecol. 2018 51:274-277.* | ||
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41. Kagan et al. Ultrasound Obstet Gynecol. 2017 Sep 19 | ||
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42. Kornman et al. Fetal Diagn Ther. 2017 Sep 6 | ||
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43. Langlois et al. Prenat Diagn. 2017 37(12)1238-1244 | ||
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44. Miltoft et al. Ultrasound Obstet Gynecol. 2017 Jun 22. | ||
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45. Richardson et al. Prenat Diagn. 2017 Dec 37(13) 1298-1304 | ||
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46. Schmid et al. Fetal Diagn Ther. 2017 Nov 8 | ||
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47. Scott et al. J Matern Neonatal Med. June 8 2017:1-8. | ||
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48. Rolnik et al. Ultrasound Obstet Gynecol. 2018 Jan 10. | ||
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v |
Norton M, et al. N Engl J Med. 2015 Apr 23;372(17):1589-97 | |
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vi |
Langlois et al. Prenat Diagn. 2017 Dec;37(12):1238-1244 | |
SOURCE Roche Diagnostics
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