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Recent development have allowed for a new type of screening test: cell free fetal DNA in maternal blood. This new generation of tests isolates the fetus’s DNA (genetic material) directly circulating in the mother’s blood. DNA is then analyzed in the laboratory providing the most accurate screening profile currently available.
harmony™ is a non-invasive prenatal screening test which allows for the risk assessment of trisomies 21, 18 and 13 as well as the screening of sex chromosome abnormalities in the fetus. Harmony is performed on a maternal blood sample as of the 10th week of pregnancy. Screening tests for sex chromosome abnormalities and the determination of fetal sex is available upon written request from your attending physician. harmony detection rate for trisomies 21, 18 and 13 is over 99% and at 92% for sex chromosome abnormalities.
If the results of the harmony™ test are positive (high risk of a trisomy), an invasive diagnostic test will be recommended to confirm the results.
The harmony™ test is done on a simple maternal blood sample as early as the tenth week of pregnancy. Available in 5 to 11 business days, the results will indicate the risk (low or high) of the fetus having one of the conditions screened for by the test. If the risk is high, your doctor will continue to follow you and may recommend that you undergo prenatal diagnostic testing. The results of a fetal DNA test on maternal blood alone are not sufficient grounds for a medical abortion. For patients presenting with a high risk of one of the conditions screened for by the harmony™ test, a FISH test on the amniotic fluid will be offered free of charge further to an amniocentesis. In a small proportion of cases (< 4%), the test results will be inconclusive. This does not mean that the fetus has or does not have the condition, but rather that the test results were not accurate enough to determine the risk level, or that not enough of your baby’s DNA was detectable in your blood.
The harmony™ test is offered to patients with single or twin pregnancies, having had fertility treatments with or without donor sperm or eggs. The test cannot be done before the tenth week of pregnancy. The patient is responsible for ensuring the gestational age and progress of the pregnancy, as well as the number of fetuses, before proceeding with the test. Therefore, it is recommended that she have an ultrasound before undergoing the harmony™ test.
If the Fetal DNA test Harmony fails to show a result, a partial refund will be offered.
