| Clinical Study | Status | Description |
|---|---|---|
| NICE (Non-Invasive Chromosomal Evaluation) |
Published in The Gray Journal (July 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, available online) | Exclusive average risk study of Harmony test in first 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) |
First 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 (2012, available online) |
Performance for T13 detection with combined average risk and high risk women |
| Fetal Fraction—NICE substudy | Published – J Mat Fet Med (2012, available online) |
Fetal fraction same in high and low risk women |
| Fetal Fraction | Published – Fetal Diagnosis and Therapy (2012) |
Fetal fraction is correlated to placental mass |
| NITE (Non-Invasive Trisomy Evaluation) |
Enrolled | Multi-center European blinded study |
| NEXT (Non-Invasive EXamination of Trisomy) |
Enrolling | Multi-center blinded study of average risk women comparing Harmony to first-trimester combined screening |
Ariosa Diagnostics is committed to developing safe, accurate, and affordable prenatal blood tests that ensure the health of the mother and fetus. As part of our commitment, we sponsor clinical trials in the United States and abroad. More information about our US clinical trials is available at www.clinicaltrials.gov.