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Exceptional Performance

Extensive blinded, published validation data

The Harmony Prenatal Test is broadly studied, including 12 blinded published validation trials.1-12

In blinded prospective published trials including over 29,000 pregnant women from ages 18 to 50, Harmony test demonstrated exceptional sensitivity and specificity. 1-2,4,7,119

Landmark NEXT Study shows high accuracy for the general population

In the first and only blinded prospective study of its kind, the Harmony Prenatal Test proved superior to traditional first trimester screening for the detection of trisomy 21 (Down syndrome).

Read the New England Journal of Medicine paper

Study Design

Study Results

(n=15,841)



 

The Harmony Prenatal Test Shows Clear Difference Between High-Probability and Low-Probability Results12

The below graphs represent data from the blinded prospective head to head comparison study of First Trimester Screening (FTS*) against Harmony.11, 13

Data represent 15,841 patients in a general pregnancy population.13

The Harmony Prenatal Test provides clear results for trisomy 21 risk, generating a wide separation between high-probability and low-probability values, with only extremely rare (less than 1 in 1000) false-positive results.12

*Serum PAPP-A, total or free ß-hCG & Nuchal Translucency

Exceptional positive predictive value (PPV)

Positive Predictive Value (PPV) is the likelihood that a positive test result is a true-positive result. PPV varies by population.

The Harmony Test has an extremely low false-positive rate of less than 0.1% thus resulting in a high PPV for trisomy 21.1,11 The Harmony Test has a PPV for trisomy 21 of 93% in pregnancies in women age 35, where the incidence of fetal trisomy 21  is 1 in 249.1 In contrast, for this same population, the PPV of traditional first trimester screening is 6%.14

View Harmony Publications

Positive predictive value (PPV) and incidence

PPV depends on the incidence of the condition of interest. The more rare (less common) the condition, the higher the probability a positive result is a "false positive" result. 15

Testing for extremely rare conditions (1 in 10,000 incidence rate) in a routine genetic test may:

● Increase the cumulative false-positive rate of the entire test

● Increase patient anxiety and unnecessary offering of diagnostic testing for a false positive result

● Substantially lower the overall PPV of the test

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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