Reliable, Quality NIPT Results

Ariosa: The Leading Provider for
Reliable, Quality NIPT Results
The Harmony Prenatal Test is a
non-invasive maternal blood test for
the risk assessment of fetal trisomies,
including Down syndrome
Detection rate for Down syndrome
Detection rate for Down syndrome
Harmony has
revolutionized
prenatal
testing with a
highly
accurate test
Harmony
>99%
First Trimester Screen
(with NT)
85%
Triple Plus/Quad Screen
AFP Only
Maternal Age
False-positive
rate: <0.1%
81%
False-positive
rate: 5%
35%
30%
1. ACOG Practice Bulletin No. 77. Screening for fetal chromosomal abnormalities. Obstet Gynecol. 2007;109:217-227.
2. Norton, M., Brar, H., Weiss, J., Karimi, A., et al. Non-Invasive Chromosomal Evaluation (NICE) Study: Results of a Multicenter, Prospective, Cohort Study for Detection of
Fetal Trisomy 21 and Trisomy 18, Am J Obstet Gynecol. (2012), doi:10.1016/j.ajog.2012.05.021.
Harmony is the leading provider of NIPT
The Harmony Prenatal Test is available worldwide in over 50 countries,
and clinical studies support its use in an average-risk population.
Peer-reviewed evidence shows that the Harmony test has greater than
99% accuracy for the risk assessment of trisomy 21, with a less than
0.1% false positive rate.
Offers the most robust clinical validation
The Harmony Prenatal Test has been clinically validated in more patients
than any other non-invasive prenatal test, including the largest blinded
validation study and multiple independent performance studies.
Simple, flexible sample collection
With a simple blood draw at 10 or more weeks gestation, the Harmony
test can be ordered by doctors for any singleton or twin pregnancy,
including those conceived by IVF. Ariosa will contact the ordering provider
after every high-risk result and genetic counselors are on staff to answer
clinical questions. Ordering physicians can contact our client services
staff to track samples.
Innovating Together
to Improve Patient Care
www.harmonytest.com
Ariosa®, Harmony™, and Harmony Prenatal Test™ are trademarks of
Ariosa Diagnostics, Inc. ©2014 Ariosa Diagnostics, Inc. All rights reserved.
Not just any result,
a result you can trust
Why you can have confidence in the Harmony test’s performance
Harmony (USA)1
Ariosa Diagnostics
BGI (China)2
99%
Insufficient data**
False Positive Rate (T21, T18, T13)
0.15%
Insufficient data**
Test success rate of eligible samples
>99%
>99%
All
All
5 to 7
14
Blinded validation studies
Studies validating use in 1st trimester and
general screening population
Fetal fraction measured, reported and
incorporated
Combined sensitivity for trisomies (T21, T18, T13)*
Twin samples accepted
All IVF accepted
Sex chromosome aneuploidies reported
Turnaround time (business days)
The Harmony Prenatal Test offers clinical utility for a practice’s workflow
CVS
10 weeks:
12 weeks:
Ultrasound to conﬁrm
viability and gestational age
Blood drawn for Harmony
Prenatal Test
Offered in the case of:
Optional nuchal translucency ultrasound
High-risk cfDNA test result
Review cfDNA results
Thickened NT
Other ultrasound ﬁndings
A study by the Fetal Medicine Centre in London explored the feasibility of routine clinical use of NIPT
(with the Harmony test) as a primary screening tool for T21, T18, and T13 among 1,000 pregnant women
at 10 weeks’ gestation.
Results showed that 15 high-risk Harmony results (ten trisomy 21, four trisomy 18, and one trisomy 13)
were confirmed by invasive diagnostic testing.
In this study, the overall FPR for Harmony was 0.1% compared to 3.4% with First Trimester Screening
(There were no "false positive" Harmony results for trisomy 21).
* Estimate based on an average-risk population with prevalence for T21, T18, and T13 of 1 in 700, 1 in 5000, and 1 in 16000 respectively.
** As of the date of printing, validation studies for these tests were not published or involved less than 10 patients.
1. Harmony references: Norton M.E., et al. Am J Obstet Gynecol. (2012) 207:137.e1-137.e18; Nicolaides K.H., et al. Am J Obstet Gynecol. (2012) 207:374.e1-6.; Ashoor G., et al. Ultrasound Obstet Gynecol. (2013) Jan;41(1):21-5.
2. NIFTY references: Dan S., et al. Prenat Diagn (2012) 32, 1-8.;Tze K.L., et al., J Matern Fetal Neonatal Med (2012); Early Online: 1-5.; Tze Kin Lau, et al. J Matern Fetal Neonatal Med. (2012) October; 25(10): 1856-1859.
Innovating Together
to Improve Patient Care
www.harmonytest.com
Ariosa®, Harmony™, and Harmony Prenatal Test™ are trademarks of
Ariosa Diagnostics, Inc. ©2014 Ariosa Diagnostics, Inc. All rights reserved.

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