Photo Credit: Roche Diagnostics

Harmony® Test: The first non-invasive prenatal test approved by Health Canada

Saturday, November 9, 2019 8:00:00 AM

- Canadian women now have access to an approved non-invasive prenatal test. -

(Roche Diagnostics) - Pregnant women can rely on the HARMONY test, the first non‑invasive prenatal test approved by Health Canada.

As early as the 10th week of pregnancy, the HARMONY test can analyze fetal cell-free DNA in a sample of the mother's blood and determine the probability of trisomy 21 (Down syndrome) and other common fetal aneuploidies.

The HARMONY test is the only test of its kind to be recognized by Health Canada as meeting its requirements of safety, effectiveness and quality. The HARMONY test is also CE-marked in Europe.

"With this first Health Canada license* granted for a non-invasive prenatal test, Roche is setting a new standard. Pregnant women and health care professionals can now rely on the only test having met the Medical Devices Bureau of Health Canada's rigorous requirements. This is an important recognition about the HARMONY test's consistent technical and clinical performance,'' says Tonino Antonetti, Executive Director, Regulatory Affairs & Quality Management, at Roche Diagnostics, Division of Hoffmann-La Roche Limited, in Canada.

Recognized and proven

With over 59 peer-reviewed publications, Harmony is the most proven non-invasive prenatal test. In clinical studies, it has been shown that Harmony can detect > 99% of trisomy 21 cases, 97.4% of trisomy 18 cases and 93.8% of trisomy 13 cases, with a false positive rate of less than 0.1%.i This non-invasive prenatal test is available in more than 100 countries worldwide to pregnant women of ages 18 years and older.

Screening programs across Canada

In the clinical practice guideline published in September 2017, 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, through an informed counselling process, the option of a prenatal screening test for the most common fetal aneuploidies''. ii

Non-invasive prenatal screening tests are currently reimbursed under certain conditions in Ontario (since 2015), British Columbia (since 2016) and Yukon (since 2017). In April 2018, the Quebec Government announced that it would, in the year to come, move forward with public funding for such a test in high-risk pregnancies.

About the Harmony Non-Invasive Prenatal Test

The Harmony non-invasive prenatal test is validated for pregnant women of 18 years and older with more than 1.4 million tests performed worldwide. Over 218,000 samples have been included in 59 peer-reviewed publications regarding the Harmony test iii, including the landmark NEXT study iv published in The New England Journal of Medicine. These studies show that the Harmony test was statistically superior to the existing first-trimester screening practice for the detection of trisomy 21.

The Harmony non-invasive prenatal test is based on cell-free DNA and is considered a prenatal screening test, not a diagnostic test. Harmony does not screen for potential chromosomal or genetic conditions other than those expressly identified in this document. All women should discuss their results with their healthcare provider who can recommend confirmatory, diagnostic testing where appropriate.