Women (age 18-48, mean age 30.7) with singleton pregnancies between 10 to 14 weeks’ gestation.
(affected pregnancies correctly identified as high risk)
(unaffected pregnancies incorrectly identified as high risk)
Positive Predictive Value (PPV)
(likelihood that a positive result is confirmed on diagnostic testing, based on false-positive rate and population frequency)
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.