Harmony Prenatal Test

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 and is validated for use in pregnant women, of any age or risk category. In contrast, conventional prenatal screening methods using serum proteins and ultrasound have a higher false-positive rate, causing healthcare providers and their patients more worry and invasive testing.


Harmony is Validated in Women of All Ages2-8, 11-13
  • 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 Clinical studies in >22,000 women of all ages
       o Over 300,000 pregnancies tested worldwide


Detection and False-Positive Rates of Conventional Trisomy 21 Tests versus Harmony1




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 21:2-8

       o False-positive rate was less than 0.1%
       o Detection rate was greater than 99%



Harmony Performance2-7

Trisomy 21 PERFORMANCE COMBINED PERFORMANCE
(Trisomies 21, 18, 13)14
DETECTION RATE >99%
DETECTION RATE 99%
FALSE-POSITIVE RATE <0.1% FALSE-POSITIVE RATE 0.15%
Exceptional Positive Predictive Value
Harmony’s false-positive rate of less than 0.1% gives
it one of the highest positive predictive values (PPV*) for trisomy 21 of any cell-free DNA-based trisomy 21 test
or conventional screening test.1, 4
Clear Answers Early to Reduce Follow-up
Harmony may minimize anxiety and follow-up invasive procedures by delivering clear information about
trisomies 21, 18, and 13 earlier in pregnancy.
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.
Optional Fetal Sex Chromosome Assessment
• Information on sex chromosome aneuploidies can be requested.
  - Including risk for monosomy X, XXX, XXY, XYY, and XXYY.






Why Choose Harmony?

  • Unsurpassed accuracy for any age or risk
    • Studied in over 22,000 women of all ages
    • Less than 0.1% false-positive rate for trisomy 21
  • Most widely used test in over 300,000 pregnancies and over 90 countries
  • Performed as early as 10 weeks, with results in about 7 business days or less
  • May minimize invasive procedures caused by false-positive results

Three Steps to Clarity

  • Draw a maternal blood sample at 10 weeks or later in pregnancy.
  • Submit sample directly to Ariosa Diagnostics or through one of our clinical laboratory partners.
  • Receive results in about 7 business days or less.
For More Information visit:
www.harmonytest.com