Application Detail

Status

Open

Description of Medical Service

The 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 Condition

Trisomy 21: Fetal Down syndrome
Trisomy 18: Edwards syndrome
Trisomy 13: Patau syndrome

Reason for Application

New MBS item

Medical Service Type

Investigative

Previous Application Number

Not Applicable

Associated Documentation

Application Form

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PICO Confirmation

PDF 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)

Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

11 - 12 December 2014

ESC

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MSAC

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