Most broadly studied NIPT

The Harmony prenatal test has been studied in more scientific publications than any other cell-free DNA based prenatal test.1 Performance has been extensively demonstrated in singleton and twin pregnancies and in women of any age or risk category.2-5 Other peer-reviewed studies have evaluated clinical implementation6 and accuracy and reproducibility of the Harmony prenatal test fetal fraction assessment.7

Read clinical evidence summaries.

1. Demonstrated by 48 peer-reviewed studies using the Harmony prenatal test as of Jan 2018. 2. Norton et al. Am J Obstet Gynecol.2012 Aug;207(2):137-8. 3. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-1246. 4. Nicolaides et al. Am J Obstet Gynecol.2012 Nov;207(5):374.e1-6. 5. Gil et al. Fetal Diagn Ther.2014;35:204-211. 6. Kagan et al. Ultrasound Obstet Gynecol.Sep 19. doi:10.1002/uog.18905. 7. Schmid et al. Ultrasound Obstet Gynecol. 2018; doi:10.1002/uog.19036

Fewer complex conversations

The Harmony prenatal test menu focuses on clinically relevant conditions, minimizing overall false positive rates.

“More” is not necessarily “better”.

Other NIPT labs offer testing for panels of rare microdeletion syndromes with limited medical value. Each condition tested has an associated false positive rate which adds to the total false positive rate of the test.

Harmony focuses on clinically relevant conditions and provides flexibility to order only the tests that are appropriate in a given situation. This minimizes unnecessary invasive procedures due to false positive results, while addressing the conditions that are likely to be of greatest concern for patients and providers.

View sample test reports

Positive Predictive Value

Positive predictive value (PPV) indicates the likelihood of a high probability result being a true positive. PPV is based on both the performance of the test and the prevalence of the condition in a particular population. For example, in a population of 15,841 women presenting for routine prenatal aneuploidy screening (the Harmony-NEXT study), 38 of 47 high risk Harmony results were confirmed by diagnostic testing. This corresponds to an observed PPV of 80.9% for trisomy 21 in this population.

PPV is a population-based statistic. To apply observed PPV in a clinical setting, the population or individual being screened must be directly comparable to the original population tested. The table is based on an estimated pre-test risk. Clinicians should exercise caution as these calculations are intended for educational purposes and not for patient-specific counseling.

The Harmony prenatal test was developed by Ariosa Diagnostics, a CLIA-certified laboratory. As with other laboratory-developed tests, it has not been cleared or approved by the FDA and is not available for sales as an IVD in the U.S. Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing.

ARIOSA, the Ariosa Logo, ARIOSA DIAGNOSTICS, the Ariosa Diagnostics Logo, HARMONY PRENATAL TEST and HARMONY are trademarks of Roche.

All other trademarks are the property of their respective owners.

Confidence in results

Results based on proven accurate fetal fraction evaluation

Fetal fraction, the relative amount of DNA from the pregnancy in the mother’s blood compared to the total cfDNA, is an important quality metric for NIPT.1-3 cfDNA-based prenatal tests that do not accurately evaluate nor require a minimum threshold of fetal fraction may release results based solely on maternal DNA. That’s why American College of Obstetricians and Gynecologists (ACOG), and American College of Medical Genetics and Genomics (ACMG) have emphasized the importance of fetal fraction in cfDNA-based testing.2-3

The accuracy and reproducibility of the Harmony Prenatal Test fetal fraction assessment has been demonstrated in a peer-reviewed study including over 47,500 clinical samples.

Read study Accuracy of fetal fraction measurement

1. Benn et al. Prenat Diagn 2015; 35: 725–734. 2. Gregg et al. Genetics in Medicine 2016 Oct; 18(10):1056-65. 3. ACOG Committee Opinion No. 163: Obstet Gynecol 2016 May.

The Harmony prenatal test was developed by Ariosa Diagnostics, a CLIA-certified laboratory. As with other laboratory-developed tests, it has not been cleared or approved by the FDA and is not available for sales as an IVD in the U.S. Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing.

ARIOSA, the Ariosa Logo, ARIOSA DIAGNOSTICS, the Ariosa Diagnostics Logo, HARMONY PRENATAL TEST and HARMONY are trademarks of Roche.

All other trademarks are the property of their respective owners.