The first weeks and months of pregnancy are generally characterized by excitement, nervousness, and a lot of questions. At the top of the list for many pregnant people is “Is my baby okay?”.

Across Canada, government health programs offer prenatal screening to help answer that question; however, depending on where you live, initial results may not be available until after the 16th week of pregnancy. In Québec, for example, this traditional screening is a multi-step process, with an initial result available midway through pregnancy. In the last decade, the NIPT has emerged as a new prenatal screening option that can provide results earlier.

Roche Diagnostics has a long-standing commitment to women’s health. As part of that mandate, we brought the Harmony NIPT to Canada in 2013. Since then, Harmony has been trusted by over 100,000 pregnant Canadians and their doctors.1

The Harmony test can provide important answers earlier in a pregnancy than the traditional screening. That information gives parents more time to prepare for the future and can ensure that they get the care they need from their healthcare provider (including genetic counselling) at an earlier stage in the pregnancy.

NIPTs—like Harmony—test the baby’s DNA present in the mother’s bloodstream. That means they can tell:

• a baby’s probability of having trisomy 21 (Down syndrome), trisomy 18, or trisomy 13, as well as other chromosomal conditions; and

• the baby’s sex.

Choosing an NIPT, such as Harmony, means results you can trust as early as 10 weeks, rather than waiting until you are halfway through your pregnancy.

The Harmony test is a simple blood test, available as early as 10 weeks.

• Trisomy 18

• Trisomy 13

• 22q11.2 deletion syndrome*

• Sex chromosome aneuploidies

• The Harmony test can also detect the baby's sex starting at Week 10.

*The 22q11.2 test is not part of the Health Canada approval of the Harmony prenatal test and is performed at a CLIA-approved laboratory in the United States. This test must be requested at the time of the order and cannot be added after submission of the original test requisition/specimens.

The Harmony test is available across Canada.
Harmony may be covered by your insurance. Check with your provider for details.

• Harmony is available for all pregnancies. Regardless of risk factors, pregnant people over age 18 can choose to have the Harmony test. The Harmony test is available for singleton and twin pregnancies, including those conceived by in vitro fertilization (IVF) and/or with an egg donor.

• The Harmony test can be performed as early as 10 weeks! The test itself requires only a single blood draw, with results ready 7-10 business days later.

• Harmony has been trusted by more than 100,000 pregnant Canadians and their pregnancy care providers and has been available in Canada since 2013.1

• The Harmony test is highly accurate. It correctly detects trisomy 21 (Down syndrome) in 99% of cases and has a false-positive rate of 3 in 100 for traditional prenatal screening in Québec).2,3

Although pregnancy comes with a lot of questions, the Harmony test can provide reliable information that helps families prepare for the future.

References

1. Roche Canada. Data on file.

2. Norton EM et al. N Engl J Med. 2015;372(17): 1589-97.

3. Programme Québécois de dépistage prenatal de la trisomy 21. Health and Social Services Québec. Available from: