FAQs for healthcare providers

 
†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.
  • What is the Harmony™ Prenatal Test?

    Harmony is a non-invasive, cell-free DNA-based blood screening test that assesses the risk 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 little as 3 days, most in 5 days after sample receipt.

    Harmony uses a directed (targeted) approach, analyzing only the chromosomes of interest. This, along with the measurement of fetal cell-free DNA contribution using single-nucleotide polymorphism (SNP), yields robust and accurate results.7

  • Does Harmony Prenatal Test assess risk for other genetic conditions in addition to trisomies 21, 13, and 18?

    Yes. Harmony includes the option of testing for the following conditions: monosomy X, XXX, XXY, XYY, and XXYY. 

  • How do I incorporate Harmony Prenatal Test into my practice?

    Following confirmation of a pregnancy, order Harmony 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. Harmony can be used in conjunction with NT ultrasound. Patient education is similar to that required for conventional trisomy screening tests.

  • How do I order Harmony Prenatal Test?

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

  • Is assistance available to help patients pay for the Harmony Prenatal Test?

    Many U.S. insurance plans include coverage of the Harmony Prenatal Test. In addition, the makers of Harmony, Ariosa Diagnostics, offer three assistance programs to help provide access to the test for any pregnant woman regardless of age or risk. Please note, the Harmony Access Program is only available in the United States and U.S. Territories.

    Learn more about the Access programs.

  • Is the Harmony Prenatal Test validated for use in pregnancies of any age or risk?

    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.1

    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.

  • What is the false-positive rate of Harmony Prenatal Test for trisomy 21?

    In blinded prospective studies of over 22,000 pregnant women ages 18-48, Harmony’s false-positive rate was less than 0.1%.1-2,8-9,11 False-positive rates for most conventional screening tests are generally around 5%.4

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

  • What is the positive-predictive value (PPV) of Harmony Prenatal Test?

    Positive predictive value (PPV) is the probability that a positive test result is a true positive. PPV is based on both the performance of the test and the prevalence of the condition in a particular population. In blinded published studies, Harmony has been shown to have a PPV of 93% in the high-risk populationi and 81% in the general populationii.1-2 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 Harmony 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.

  • How early can the Harmony Prenatal Test be performed?

    Harmony can be ordered for women as early as 10 weeks' gestational age, as well as later in pregnancy.

  • How is Harmony Prenatal Test different from conventional trisomy screening tests?

    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%.4 
    Harmony 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.

  • How is Harmony Prenatal Test different from other cell-free DNA (cfDNA) tests?

    Only the Harmony test uses a unique targeted approach (DANSRTM and FORTETM) to more accurately assess the chromosomes of interest. In addition, Harmony’s methodology includes SNPs analysis which distinguishes maternal from fetal DNA and quantifies the fetal DNA. 7, 12 The amount of fetal DNA is incorporated into the risk assessment and reported in the final test result; each patient receives an individualized risk score. 7

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