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
Table 4: Clinical Studies & Publication Overview.