When it comes to prenatal screening the Harmony Prenatal Test provides healthcare professionals with a non-invasive screening option that adheres to clinically relevant testing and actionable insights. Harmony can be performed with or without nuchal translucency (NT) ultrasound and other prenatal procedures. The Harmony Prenatal Test fits into your protocols just like any other screen.
Providing Harmony
The Harmony Prenatal Test is a cell-free DNA test that evaluates your patient’s risk for trisomy 21, trisomy 18, trisomy 13 as early as 10 gestational weeks. Additional menu options include monosomy X and other sex chromosome aneuploidies, 22q11.2 microdeletion, and fetal sex. Harmony is validated for use in pregnant women of any age* or risk category and can be used in singleton, twin, and self-and non-self egg donor pregnancies. Expecting parents will benefit from the knowledge Harmony provides and healthcare professionals will appreciate the easy integration into routine protocols.
Access for expecting parents
Using the Harmony Prenatal Test in your practice may help minimize follow-up diagnostic testing and the associated complications.1 To assist you and
your patients understand their cost we have dedicated Harmony Care Specialist. Call and speak with a specialist today at 1-855-927-4672.
A simple process
The Harmony Prenatal Test is a simple process for you and your patients.
To support you and your practice we offer the following resources to healthcare providers:
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.
References: 1. Langlois et al. Prenat Diagn. 2017 Dec;37(12):1238-1244.
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
Fewer complex conversations
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.
Combined Performance Across All Clinical Studies
The Harmony Prenatal Test delivers consistent, industry-leading performance for trisomy 21, trisomy 18 and trisomy 13 across clinical studies.3
Confidence in results
Results based on proven accurate fetal fraction evaluation. Fetal fraction is the amount of cell-free DNA (cfDNA) coming from the pregnancy that is present in the blood sample. Underestimating fetal fraction may cause valid samples to be rejected, and overestimating could lead to samples with insufficient cell-free DNA giving a false negative result.8 The Harmony Prenatal Test requires a minimum of 4% fetal fraction as a quality control metric to ensure there is enough DNA from the pregnancy to produce an accurate patient result.
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.7
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.
*Both under 35 and over 35 age groups, studies have included women ages 18-48.
References: 1. Data on File at Roche Diagnostics. 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 Fetal Diagn Ther 2019; 45(5):317-324. 7. Schmid et al. Ultrasound Obstet Gynecol. 2018; doi:10.1002/uog.19036. 8. Artieri et al. Prenat Diagn. 2017 May;37(5):482-490. doi: 10.1002/pd.5036. Epub 2017 Apr 26.
Superior performance in the general population
The Harmony Prenatal Test significantly outperformed traditional First Trimester Screening (FTS*) in the landmark study (NEXT) published in the New England Journal of Medicine. In this prospective blinded study, Harmony was found to be superior to FTS* in detection rate, false-positive rate, and positive predictive value for trisomy 21.1
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 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.
Professional Societies
Professional societies such as the American College of Obstetricians and Gynecologist, Society for Maternal Fetal Medicine, and the American College of Medical Genetics and Genomics support offering cell-free DNA screening.2,3
ACOG/SMFM “all women should be offered the option of aneuploidy screening for fetal genetic disorders, regardless of maternal age.”3
ACMG “informing all pregnant women that non-invasive prenatal screening is the most sensitive screening option for traditionally screened aneuploidies (i.e. Patau, Edwards, and Down syndrome)."2
Importance of fetal fraction
Fetal fraction, the relative amount of DNA from the pregnancy in the mother’s blood compared to the total cell-free DNA (cfDNA), is an important quality metric for NIPT.2,4,5 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 ACMG position statement acknowledges that data suggest the lower limit of fetal cfDNA for a reliable result is approximately 4%.2
There are different methodologies that can be used to measure fetal fraction, and these different methods have varying degrees of accuracy. The core technologies of the Harmony Prenatal Test incorporate fetal fraction into results to accurately distinguish high and low probability results (even at low fetal fraction).
Targeted approach to deeper analysis
The Harmony Prenatal Test relies on a proprietary, targeted DNA-based technology including both the Digital Analysis of Selected Regions (DANSR™) assay quantified on microarray and Fetal Fraction Optimized Risk of Trisomy Evaluation (FORTE™) algorithm to provide exceptionally accurate results.
DANSR
FORTE
Individualized probability score for your patient
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.
References: 1. Norton et al. N Engl J Med. 2015 Apr 23;372(17):1589-97. 2. Gregg et al. Noninvasive prenatal screening for fetal aneuploidy. Genetics in Medicine. 2016 Oct;1-10. 3. ACOG Committee Opinion No. 163: Obstet Gynecol 2016 May. 4. Benn et al. Prenat Diagn 2015; 35: 725–734. 5. Palomaki et al. Genet Med 2012;14:296-305. 6. Canick et al. Prenat Diagn. 2013 Jul;33(7):667-74. 7. Wang et al. Prenat Diagn. 2013;33:1-5.
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.
*Both under 35 and over 35 age groups, studies have included women ages 18-48
References: 1. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-6. 2. Norton et al. New England J of Medicine. 2015; 372(17):1589-1597. 3. Gil et al. Fetal Diagn Ther. 2014;35:204-11. 4. ACOG Committee Opinion No. 163: Obstet Gynecol 2016 May.
To begin the process, please complete each of the required fields (marked with an asterisk) below and a representative will contact you. If you have questions, please call a Harmony Care Specialist today at 1-855-927-4672.
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.
