Clear ANSWERS to Questions that Matter

Clear ANSWERS
to Questions that Matter
Harmony Prenatal Test evaluates the risk for trisomies 21, 18, and 13 with
unsurpassed accuracy in women of any age or risk category
A Higher Standard of Care in TRISOMY TESTING
AS EARLY AS 10 WEEKS, the Harmony Prenatal Test assesses the risk of trisomy 21 with
unsurpassed accuracy in pregnant women, of any age or risk. In the first and only prospective
blinded study of its kind published in the New England Journal of Medicine, the Harmony
Prenatal Test proved superior to traditional first trimester combined screening for both
detection rate and false-positive rate.15
Harmony is Validated in
Women of All Ages 2-8, 11-13, 15
• Harmony Prenatal Test is clinically validated for use in
pregnant women, of any age or risk category, to assess
the likelihood of fetal trisomies 21, 18 and 13
• Harmony is the most broadly studied cell-free
DNA-based maternal blood test
o Blinded clinical studies in >22,000 women of all ages
o Over 400,000 pregnancies tested worldwide
Harmony Outperforms First Trimester Combined Screening (FTS*) in both Detection and
False-Positive Rate in a head to head comparison blinded study (n=15,841)
Study Results
Study Population
Women (age 18-48, mean age of 30.7) with
singleton pregnancies between 10 to 14 weeks
gestation.
p=0.008
Detection Rate
(more than 1 in 5 affected pregnancies
Study Design
18,955 enrolled & each woman received both
First Trimester
Screening (FTS*)
n=15,841
&
Each pregnancy was followed.
Outcome data obtained by:
Harmony Prenatal
Test (Results
blinded)
Genetic testing
(38 of 38)
FTS*
(30 of 38)
100%
79%
p<0.001
False-Positive Rate
Harmony (9 of 15,803)
0.06%
(Harmony reduces false-positives by
more than 90-fold)
FTS* (854 of 15,803)
5.4%
or
Newborn exam
n=15,841 (women with both FTS* and Harmony and outcome data)
*Serum PAPP-A, total or free ß-hCG & Nuchal Translucency
may go undetected with FTS*)
Harmony
Positive Predictive Value
(PPV)
(likelihood that a positive result is
confirmed on diagnostic testing, based
on false-positive rate and
population frequency)
p<0.001
Harmony Prenatal Test
FTS*
3.4%
81%
CLEAR ANSWERS TO QUESTIONS THAT MATTER
Unsurpassed ACCURACY
Harmony Prenatal Test delivers unsurpassed accuracy when compared to any other trisomy 21
blood test.
In blinded studies of over 22,000 pregnant women age 18 to 50 for trisomy 21:
Harmony Performance Across All Blinded Studies 2-7, 15
Trisomy 21 PERFORMANCE
COMBINED PERFORMANCE (Trisomies 21, 18, 13)14
DETECTION RATE
>99%
DETECTION RATE
99%
FALSE-POSITIVE RATE
<0.1%
FALSE-POSITIVE RATE
<0.1%
The Difference in Performance is Clear
This study of blinded prospective 15,841 patients compares First Trimester Combined Screening
(FTS*) with Harmony in a general pregnancy population.15
• The Harmony test accurately identified all 38 trisomy 21 cases, versus 30 out of 38 with FTS*.
• F TS* produced 5.4% (n=854) false-positives, compared to Harmony which had 0.06% (n=9) false-positives for trisomy 21
First Trimester Screening
Harmony
Prenatal
Harmony
Prenatal Test Test
Harmony Prenatal Test
99
99
10
10
10
10
10
10
1
Positive is risk ≥ 1 100
T21 risk (%)
T21 risk (%)
1
1
T21 risk (%)
(%) ≥ 1/100
PositiveT21
is risk
risk
99
Positive is risk ≥ 1 100
99
Positive is risk ≥ 1 270
99
99
Positive is risk ≥ 1 270
T21 risk (%)
(%) ≥ 1/270
PositiveT21
is risk
risk
First Trimester
Combined
First Trimester
Screening Screening
1
T21 True-positives
0.1
0.1
0.1
1
1
0.1
0.1
0.1
T21 True-negatives
15,794 Harmony
low-risk results
@ < 1 in 10,000 8
T21 False-positives
0.01
0.01
0.01
10
10
10.5
10.5
11
11
11.5
11.5
12
12
12.5
12.5
Gestational age (wks)
13
13
0.01
1013.5
13.5 10.514
14 11
Gestational age (weeks)
T21 True−positives
T21 True−negatives
11.5
T21 False-negatives
1210
12.5
10.5
Gestational age (wks)
T21 False−positives
1311
13.5
11.5
T21 False−negatives
T21 True−positives
Exceptional Positive Predictive Value for the
General Population
• 3.4% for first trimester screening versus 81% for Harmony
(PPV is the likelihood that a positive result is confirmed
on diagnostic testing, based on false-positive rate and
population frequency)
Harmony’s Targeted Technology
Yields Optimal Results
• Only Harmony uses a unique targeted approach to more
accurately assess the chromosomes of interest.
• Harmony’s methodology includes precise measurement
of the amount of fetal DNA and incorporates it into the risk
assessment, providing a more accurate result.
0.01
0.01
1412
12.5
Gestational age (wks)
T21 True−negatives
13
10.514 11
1013.5 10.5
11.5
12
12.5
12.5
Gestational age (wks)
13
13.5
13.5
14
14
Gestational age (weeks)
T21 False−positives
T21 False−negatives
Clear Answers Early to Reduce Follow-up
The greater accuracy and low false-positive rate of Harmony
compared to traditional tests may minimize the chance
further testing would be recommended due to a falsepositive result.
Optional Fetal Sex Chromosome Assessment
• Information on sex chromosome aneuploidies can
be requested.
o Including risk for monosomy X, XXX, XXY, XYY,
and XXYY.
*Serum PAPP-A, total or free ß-hCG & Nuchal Translucency
Clear answers to questions that matter.
Why Choose Harmony?
• Unsurpassed accuracy for any age or risk
o
Blinded studies in over 22,000 women of all ages
o
Less than 0.1% false-positive rate for trisomy 21
• Most widely used test–in over 400,000 pregnancies and over 100 countries
• Performed as early as 10 weeks
• May minimize invasive procedures caused by false-positive results
Three Steps to Clarity
1. Draw a maternal blood sample at 10 weeks or later
in pregnancy.
2. Submit sample directly to Ariosa Diagnostics or
through one of our clinical laboratory partners.
3. Receive results in about 7 business days or less.
Visit us at harmonytest.com
For assistance email clientservices@ariosadx.com or call 1-855-9-ARIOSA (855-927-4672)
Outside the USA, call +1 925-854-6246
Non-invasive prenatal testing based on cell-free DNA analysis is not considered diagnostic.
© 2015 Ariosa Diagnostics, Inc. All Rights Reserved. ARIOSA, the Ariosa Logo, ARIOSA DIAGNOSTICS, the Ariosa Diagnostics Logo, HARMONY PRENATAL TEST and HARMONY are trademarks or
registered trademarks of Ariosa Diagnostics, Inc. in the U.S.A. and other countries. All other trademarks are the property of their respective owners. MM-00432-040115-Rev2.0
1. ACOG Practice Bulletin No. 77. Obstet Gynecol 2007;109:217-27.
2. Sparks AB et al., Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9.
3. Ashoor G et al., Am J Obstet Gynecol. 2012 Apr;206(4):322.e1-5.
4. Norton M et al., Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8.
5. Nicolaides KH et al., Am J Obstet Gynecol. 2012 Nov;207(5):374.e1-6.
6. Ashoor G et al., Ultrasound Obstet Gynecol. 2013 Jan;41(1):21-5.
7. Verweij EJ et al., Prenat Diagn. 2013 Oct;33(10):996-1001.
8. Data on file at Ariosa Diagnostics, Inc.
9. Palomaki G et al., Genet Med. 2011 Nov;13(11):913-20.
10. Bianchi D et al., Obstet Gynecol. 2012 May;119(5):890-901
11. Hooks J et al., Prenat Diagn. 2014 May;34(5):496-9.
12. Nicolaides K et al., Fetal Diagn Ther. 2014;35(1):1-6.
13. Gil M et al., Fetal Diagn Ther. 2014;35:204-11.
14. 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.
15. Norton M, et al, NEJM DOI: 10.1056/NEJMoa1407349 (published
online April 1, 2015)