Study |
Status |
Description |
NICE
(Non-Invasive Chromosomal Evaluation) |
Published–Editor’s choice in The Gray Journal (August 2012) |
Multi-center (50 sites) clinical validation study, combined high risk and low risk women. Largest NIPT cohort study. |
Average Risk (Nicolaides) |
Published–The Gray Journal (2012, avail online) |
Exclusive average risk study of Harmony test in 1st trimester pregnancy |
Ariosa Blinded |
Published–Editor’s choice in The Gray Journal (April 2012) |
Blinded study with risk score reporting |
Nicolaides Blinded |
Published–Editor’s choice in The Gray Journal (April 2012) |
1st trimester blinded study |
Proof of Concept |
Published–cover article Prenatal Diagnosis (Jan 2012) |
Initial description of directed cfDNA approach with combined average risk and high risk women |
Trisomy 13 |
Published–The White Journal (Jan 2013) |
Performance for T13 detection with combined average risk and high risk women |
Fetal Fraction–NICE substudy |
Published–J Mat Fet Med (Jan 2013) |
Fetal fraction same in high and low risk women |
Fetal Fraction |
Published–Fetal Diagnosis and Therapy (2012) |
Fetal fraction correlated to placental mass |
NITE
(Non-Invasive Trisomy Evaluation) |
Completed and under review |
Multi-center European blinded study |
NEXT
(Non-invasive EXamination of Trisomy) |
Enrolling |
Multi-center blinded study of average risk women comparing Harmony to 1st trimester combined screening |