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

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.