Landmark Study Shows Unsurpassed Accuracy for the General Population

Landmark Study Shows Unsurpassed Accuracy for the General Population

Landmark Study Shows Unsurpassed Accuracy for the General Population

In the first and only blinded prospective study of its kind, the Harmony Prenatal Test proved superior to traditional first trimester screening for the detection of trisomy 21 (Down syndrome).

Read paper: New England Journal of Medicine Video: Harmony NEXT Study (Dr. Ron Wapner)

Study Population

Women (age 18-48, mean age 30.7) with singleton pregnancies between 10 to 14 weeks’ gestation.

Study Design

1 8 , 9 5 5 e n r o l l e d & e a c h w o m a n r e c e i v e d b o t h *Serum PAPP-A, total or free ß-hCG & Nuchal Translucency Each pregnancy was followed. Outcome data obtained by: Harmony Prenatal T est (Results blinded) First Trimester Screening (FTS*) & Genetic testing Newborn exam or n=15,841 (women w/both FTS & Harmony & outcome data) or

Study Results

(n=15,841)

p=0.008

Detection Rate

(affected pregnancies correctly identified as high risk)

Harmony (38 of 38)100%
FTS* (30 of 38)79%

p‹0.001

False-Positive Rate

(unaffected pregnancies incorrectly identified as high risk)

Harmony (9 of 15,803)0.06%
FTS* (854 of 15,803)5.4%

p‹0.001

Positive Predictive Value (PPV)

(likelihood that a positive result is confirmed on diagnostic testing, based on false-positive rate and population frequency)

Harmony Prenatal Test81%
FTS*3.4%

Reducing False Positives by over 90-Fold

854 women received a false-positive high-risk results with first trimester screening compared to only 9 women with the Harmony Prenatal Test.

854 of 15,803 False positives with FTS
9 of 15,803 False positives with Harmony

Exceptionally Accurate Results

Trial results show that more than 1 out of 5 affected pregnancies may go undetected with first trimester screening (FTS). Harmony was far superior to FTS in identifying fetuses with Down syndrome.

30 of 38 Sensitivity of FTS in detecting Down syndrome
38 of 38 Sensitivity of Harmony in detecting Down syndrome

Behind Harmony’s Unsurpassed Accuracy

  • Harmony is a cell-free DNA test which uses a proprietary targeted assay DANSRTM for deeper analysis.
  • Harmony’s FORTETM algorithm incorporates fetal fraction, maternal age and gestational age to provide an individualized risk score for each patient.