The Harmony Test for Pregnant Women: Non-Invasive Prenatal Testing

10+ weeks

Ariosa Diagnostics, Inc., is a molecular diagnostics company committed to innovating together to improve patient care. The flagship product, the Harmony Prenatal Test, is a safe, highly accurate and affordable prenatal test for maternal and fetal health. Led by an experienced team, Ariosa is using its proprietary technology to perform a directed analysis of cell-free DNA in blood. The Harmony test equips pregnant women and their healthcare providers with reliable information to make decisions regarding their health, without creating unnecessary stress or anxiety.

The company was acquired by Roche in January 2015 with operations based in San Jose, Calif. For more information, visit www.ariosadx.com.

Harmony NIPT samples are processed in the UK by The Doctors Laboratory

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Click here to visit: Harmony test for Patients

TEST HARMONY
Company website http://www.ariosadx.com/
COMPANY ARIOSA
Test Origin USA
Laboratory Location TDL London
Type of cfDNA analysis Targeted Direct Analysis
Screen Population All Pregnant Women any age or risk category
Number of tests performed >500,000
Clinical data number re test performance >22,000
About the test
Gestational age 10+ weeks
Pregnancies Screened
Singletons
Naturally conceived YES
IVF (Self) YES
IVF (Donor) YES
Multiples (Twins)
Naturally conceived YES
IVF (Self) YES
IVF (Donor) YES
Risk analysis All give individualized risk score plus high / low result for each patient
Fetal fraction redraw level <4%
Fetal fraction quoted YES
Redraw rate 3%
Chance of result after 2nd blood sample 65%
Chromosomes analysis Current Validated Detection Rates 01/06/2015
Combined false positive rate T12/T18/T13 <0.1%
T21 Down’s syndrome >99%
T18 Edwards’ syndrome 97.4%
T13 Patau’s syndrome 93.4%
Triploidy n/a
Fetal sex / presence of Y chromosome: accuracy YES: Singleton and twin pregnancies > 99%
Sex Aneuploid Conditions Y aneuploidy (optional no extra charge)
X0 (Turner syndrome) YES (Singleton only)
XXX (Triple X) YES (Singleton only)
XYY (Jacobs syndrome) YES (Singleton only)
XXY (Klinefelter syndrome) YES (Singleton only)
Micro deletions (Optional) NO
Turnaround Time (TAT) working days 3-5 Working days