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Harmony

Harmony is validated for pregnant women of any age or risk categories* and trusted by clinicians worldwide. AS EARLY AS 10 WEEKS, the Harmony Prenatal Test screens for the risk of trisomy 21, 18, and 13.

 

Test Information

Harmony

Harmony is validated for pregnant women of any age or risk categories* and trusted by clinicians worldwide. AS EARLY AS 10 WEEKS, the Harmony Prenatal Test screens for the risk of trisomy 21, 18, and 13.

The Harmony Prenatal Test, developed and validated by Ariosa Diagnostics Inc, analyses circulating cell-free foetal DNA extracted from a maternal blood sample, from as early as 10 weeks gestation, to predict the risk of Down syndrome (trisomy 21) and two other genetic conditions – Edward syndrome (trisomy 18) and Patau syndrome (trisomy 13). Harmony Prenatal Test can also be used to evaluate X and Y sex chromosome aneuploidies such as Turner and Kleinfelter syndromes.

This test assesses the risk of trisomy 21 with unsurpassed accuracy and is validated for use in pregnant women, of any age or risk category, with blinded clinical studies in more than 22,000 women and over 350,000 pregnancies tested worldwide. In contrast, conventional prenatal screening methods using serum proteins and ultrasound have a higher false positive rate. The greater accuracy and lower false positive rate of the Harmony Prenatal test, compared to conventional tests, minimises the chance that invasive follow up procedures, such as CVS or amniocentesis, would be unnecessarily recommended.
Detection and False-Positive Rates of Conventional Trisomy 21 Tests versus Harmony*

 

Reference:

*ACOG Practice Bulletin No. 77. Obstet Gynecol 2007;109:217-27

Clinical Trial

For a summary of the clinical studies behind this test refer to the Clinical Studies Abstract.

Results

Results are available within about 10 business days of a patient’s sample being collected at any of Australian Clinical Labs' collection sites.
Samples are tested by Australian Clinical Labs in Australia.

Genetic Counselling

Genetic counselling will be offered to all women whose test result is positive. This service may be provided, at your doctor’s discretion, in one of the following ways:
• Your doctor may choose to provide the genetic counselling themselves;
• By the Australian Clinical Labs allied genetic counselling service (no additional fee applies);
• By referral from your doctor to a local genetic counselling service.

Cost

This test is not currently covered by Medicare or private health insurers in Australia.
The out-of-pocket expense for this test is $430.
Importantly, you must bring with you a completed Harmony Prenatal Test request and payment form.

Request Form

Harmony Prenatal Test request and payment form.