Australian Government - Department of Health

Medical Services Advisory Committee (MSAC)

1396 - Noninvasive prenatal testing for common trisomies (21, 18 and 13)

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Comment on the Draft protocol closed at 1159 on 14 November 2014

Application Number1396
Application NameNoninvasive prenatal testing for common trisomies (21, 18 and 13)
Description of Medical ServiceThe Harmony Prenatal Test is an Ariosa laboratory-developed test, which assesses the risk of fetal aneuploidies via analysis of cell-free DNA (cfDNA) in maternal blood. As fetal cfDNA represents a more direct marker of Down syndrome and other aneuploidies, the Harmony test is able to have much higher accuracy as compared to traditional screening tests. The Harmony Prenatal Test has been analytically validated per the Clinical Laboratory Improvement Act and College of American Pathologists regulatory requirements
Description of Medical ConditionTrisomy 21: Fetal Down syndrome
Trisomy 18: Edwards syndrome
Trisomy 13: Patau syndrome
Draft ProtocolPDF Version Unratified Draft Protocol for Consultation (PDF 329 KB)
Word Version Unratified Draft Protocol for Consultation (Word 97 KB)

PDF Version Feedback and Survey Form (PDF 155 KB)
Word Version Feedback and Survey Form (Word 55 KB)
Final Protocol-
Reports-
MSAC Outcomes-

Meetings for this Application

Meeting Type:Date:
PASC11-12 December 2014
ESC -
MSAC -

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