Applications

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

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Pre-assessment
  • Type -
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome -

Application details

Reason for application

New MBS item.

Service or technology in this application

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.

Type: Investigative

Medical condition this application addresses

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

Meetings to consider this application

  • PASC meeting: 11 - 12 December 2014
  • ESC meeting: -
  • MSAC meeting: -