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Exceptional Performance

The Harmony test is a non-invasive, cell-free DNA-based blood screening test that assesses the probability of fetal trisomy 21, 18, and 13 in women of any age or risk factors†. Harmony has a detection rate of greater than 99% and a false-positive rate of less than 0.1% for trisomy 21.1

The Harmony test can be performed as early as 10 weeks’ gestation, and results are received in as soon as 3 days, most in 5 days after sample receipt.

Harmony uses a directed (targeted) approach, analyzing only the chromosomes of interest.

Yes. Harmony includes the option of testing for sex chromosome aneuploidies ( monosomy X, XXX, XXY, XYY, and XXYY) and 22q11.2 deletion. 

Following confirmation of a pregnancy, order the Harmony test as early as 10 weeks gestational age. Administer a simple blood draw directly or through a participating laboratory and send it to Ariosa Diagnostics using the specimen collection and transportation kit. Receive a report detailing test results in as little as 3 days, most in 5 days after sample receipt. The Harmony test can be used in conjunction with NT ultrasound. Patient education is similar to that required for conventional trisomy screening tests.

Call 1-855-927-4672. Outside the USA, call +1 925-854-6246. For general assistance, email sjc.clientservices@roche.com.

Yes. The Harmony Prenatal Test is validated for pregnant women of any age or risk categories, including both under 35 and over 35 age groups (studies have included women ages 18-48). In fact, recent landmark study published in the New England Journal of Medicine showed that Harmony significantly outperformed first trimester screening in both trisomy 21 detection rate and false-positive rate.2

The Harmony test is validated for singleton, twin, and IVF pregnancies (including self and non-self egg donor pregnancies).11

View our list of studies.

The false-positive rate for the Harmony test was less than 0.1% in blinded prospective studies of over 22,000 pregnant women ages 18-48.1 False-positive rates for most conventional screening tests are generally around 5%.3

Read more about the accuracy of the Harmony test versus other first trimester screening methods.

For trisomy 21, the Harmony test has been shown to have a PPV of 93% in the high-risk populationi and 81% in the general populationii in blinded published studies.1-2 Positive predictive value (PPV) is the probability that a positive test result is a true positive result. In contrast, first trimester serum screening has a PPV of 6% in the high-risk population or in a 35-year-old population.

Read more about the PPV of the Harmony test versus other first trimester trisomy screening methods.

iPPV value for trisomy 21 in a 35-year old population, incidence of 1/249.

iiPPV value for trisomy 21 in a general population (18-48), incidence of 1/417.

At 10 weeks' gestational age, a patient can request the Harmony Prenatal test.

The Harmony test is a screening test that delivers clear answers* as early as the first trimester with a single blood draw. Other conventional tests for Down syndrome are performed later in pregnancy and may require multiple office visits. Traditional serum screening tests are associated with a false-positive rate as high as 5%.3
The Harmony test uses a unique method of targeted DNA analysis that, combined with extensive quality controls, achieves over 99% in detection rate and a false-positive rate of less than 0.1% for trisomy 21.1

See details about the technology that underpins the Harmony test.

Only the Harmony test uses a unique targeted approach (DANSRTM and FORTETM) to more accurately assess the chromosomes of interest. 

Read more about how the Harmony test differs from other cfDNA-based tests.

†Both under 35 and over 35 age groups, studies have included women ages 18-48

References

†Both under 35 and over 35 age groups, studies have included women ages 18-48

  1. Norton et al. N Engl J Med. 2015 Apr 23;372(17):1589-97.
  2. Norton et al. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8.
  3. Ashoor et al. Ultrasound Obstet Gynecol. 2013 Jan;41(1):21-5.
  4. ACOG Committee on Practice Bulletin No. 77. Obstet Gynecol 2007;109:217-27.
  5. Wax et al. J Clin Ultrasound. 2015 Jan;43(1):1-6.
  6. Lou et al. Acta Obstet Gynecol Scand. 2015;94(1):15-27.
  7. Sparks et al. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9.
  8. Verweij et al. Prenat Diagn. 2013 Oct;33(10):996-1001.
  9. Nicolaides et al. Am J Obstet Gynecol. 2012 Nov;207(5):374.e1-6.
  10. Ashoor et al. Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.
  11. Gil et al. Fetal Diagn Ther. 2014;35:204-11.
  12. Juneau et al. Fetal Diagn Ther. 2014;36(4):282-6.
  13. Data on file.
  14. Hooks et al. Prenat Diagn. 2014 May;34(5):496-9.
  15. Sparks et al. Prenat Diagn. 2012 Jan;32(1):3-9.
  16. Nicolaides et al. Fetal Diagn Ther. 2014;35(1):1-6

The Harmony Prenatal Test is a non-invasive prenatal test (NIPT) based on cell-free DNA analysis 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. Before making any treatment decisions, all women should discuss their results with their healthcare provider, who can recommend confirmatory, diagnostic testing where appropriate. The Harmony Prenatal Test was developed, and its performance characteristics determined by Ariosa Diagnostics, Inc., a CLIA-certified and CAP-accredited clinical laboratory in San Jose, CA USA. This testing service has not been cleared or approved by the US FDA. HARMONY and HARMONY and Design are trademarks of Ariosa Diagnostics, Inc. in the US. HARMONY is a trademark of Roche in other countries. All other trademarks are the property of their respective owners.

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