Tuesday, December 21st, 2021

New production demonstrates predictable clinical execution in screening basic fetal trisomies with Harmony Prenatal Test

Roche and Ariosa Diagnostics, Inc., a general pioneer in non-intrusive pre-origination testing (NIPT) technology and creator of the Harmony™ Prenatal Test, today maintained the postponed outcomes of another clinical study on the affiliation’s revolved around without cell DNA examination utilizing microarray quantization which indicated high affectability, specificity and to a mind blowing degree low false positive rates for pre-origination appraisal of Down turmoil and other chromosomal issue. The faithful measure execution of the Harmony Prenatal Test, passed on in Prenatal Diagnosis, was credited to its focused on without cell DNA examination system paying little identity to whether assessed by strategy for microarray or bleeding edge sequencing (NGS).

“This apportionment sets up that the Harmony restrictive focused on test shows reliably high affectability and to exceptional degree low false positive rates for vital autosomal trisomies crosswise over diverse quantization stages,” said Thomas Musci, Chief Medical Officer for Ariosa Diagnostics. “Quantization utilizing both show and cutting edge sequencing give relative execution to the Harmony test, and the microarray-based quantitation has the benefit of lower expense and higher throughput.”

Focused on without cell DNA examination utilizing DANSR™ and FORTE™, the key parts of the Harmony Prenatal Test, was utilized to review the hazard of trisomy 21 (Down perplexity), 18 and 13 in blinded illustrations from 799 single, twin, regular and IVF pregnancies. DANSR and FORTE with microarray appraisal perceived 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).

Right when converged with information from nine successfully scattered clinical studies utilizing the DANSR/FORTE method including 23,000 pregnancies, screening for each of the three trisomies was cautious in 99.9 percent of cases.

Parts of the Harmony Prenatal Test headway join lively turnaround time, flexibility, fetal piece estimation and reporting united into an individualized patient risk score. Made and went on by Ariosa, the Harmony Prenatal Test is seen worldwide for being amazingly endeavored and recognized in dispersed inescapable clinical studies.2 Ariosa’s restrictive FORTE programming has gotten the CE check (Conformité Européenne).

About the Harmony Test

The Harmony Prenatal Test is a screening test for pregnant ladies that can be utilized as right on time as 10 weeks in pregnancy. By looking over sans cell DNA found in maternal blood, including careful estimation of the fetal division of DNA, the test evaluates the danger of trisomy 21 (Down disarray) in the creating life. It has been embraced to Clinical Laboratory Improvement Amendments (CLIA) necessities by a serious clinical information set and upheld by clinical studies in more than 23,000 ladies of all ages and hazard categories.3 It is accessible in more than 100 nations and areas and has been utilized to control clinical thought in more than 500,000 pregnancies around the world.

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