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New Publication Shows Consistent Clinical Performance In Screening Common Fetal Trisomies With Harmony Prenatal Test

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Roche (SIX: RO, ROG; OTCQX:RHHBY) and Ariosa Diagnostics, Inc., a global leader in non-invasive prenatal testing (NIPT) 1 technology and maker of the Harmony™ Prenatal Test, today announced the results of a new clinical study on the company’s targeted cell-free DNA analysis using microarray quantitation which demonstrated high sensitivity, specificity and extremely low false positive rates for prenatal assessment of Down syndrome and other chromosomal disorders. The consistent assay performance of the Harmony Prenatal Test, published in Prenatal Diagnosis, was attributed to its targeted cell-free DNA analysis method regardless of whether evaluated via microarray or next generation sequencing (NGS).

“This publication establishes that the Harmony proprietary targeted assay demonstrates consistently high sensitivity and extremely low false positive rates for common autosomal trisomies across different quantitation platforms,” said Thomas Musci, Chief Medical Officer for Ariosa Diagnostics. “Quantitation using both array and next generation sequencing provide equivalent performance for the Harmony test, and the microarray-based quantitation has the advantage of lower cost and higher throughput.”

Targeted cell-free DNA analysis using DANSR™ and FORTE™, the key components of the Harmony Prenatal Test, was used to evaluate the risk of trisomy 21 (Down syndrome), 18 and 13 in blinded samples from 799 single, twin, natural and IVF pregnancies. DANSR and FORTE with microarray quantification identified 107 out of 108 trisomy 21 cases (99.1 percent), 29 out of 30 trisomy 18 cases (96.7 percent), and 12 out of 12 trisomy 13 cases (100 percent).
When combined with data from nine previously published clinical studies using the DANSR/FORTE method involving 23,000 pregnancies, screening for all three trisomies was accurate in 99.9 percent of cases.

Features of the Harmony Prenatal Test technology include rapid turnaround time, scalability, fetal fraction measurement and reporting incorporated into an individualized patient risk score. Developed and distributed by Ariosa, the Harmony Prenatal Test is recognized worldwide for being exceptionally tested and validated in published prospective clinical studies. 2 Ariosa’s proprietary FORTE software has received the CE mark (Conformité Européenne).
Read more about the clinical study here.

Source: The Street