Answers to Important Questions

PAY NOW
Do I need to book for Harmony NIPT ?

No, you do not need to make a booking for Harmony NIPT. However, for our collection centres in South Australia and the Northern Territory, we recommend calling ahead.

Please note: Payment is required before collection. To pay for your test online now, CLICK HERE.

How much does the Harmony NIPT test cost?

The Harmony NIPT test costs $430. If 22q11.2 microdeletion (DiGeorge syndrome) is also ordered, there is an additional cost of $70.

The Harmony NIPT test cost of $430 covers the Harmony Prenatal Test (T21, T18, T13) and optional add-on tests (Fetal Sex, Monosomy X, Sex Chromosome Aneuploidy Panel) when marked by the referring doctor.

How do I pay for my test?

Paying for your Harmony NIPT test is easy, simply CLICK HERE to pay for your test online now.

Please note: Payment is required before collection.

Who can have the Harmony prenatal test?

Pregnant women who are at least 10 weeks gestational age with a singleton or twin pregnancy resulting from natural conception or IVF are eligible for this analysis. However, the additional fetal sex chromosome analysis and 22q11.2 microdeletion can only be performed in singleton pregnancies. The Harmony prenatal test is validated for use in women ≥ 18 years.

How early can I have my Harmony NIPT?

Harmony NIPT can be performed any time from 10 weeks of pregnancy until delivery.

Where can I have my Harmony NIPT test?

Clinical Labs is the exclusive provider of Harmony NIPT in Australia, including 22q11.2 microdeletion. All of our collection centres across Victoria, New South Wales, Queensland, South Australia, Western Australia, the Northern Territory and the Australian Capital Territory can collect a blood sample for the Harmony prenatal test. For our collection centres in South Australia and the Northern Territory, we recommend calling ahead.

Payment is required before collection. To pay for your test online now, CLICK HERE. Please bring your Harmony NIPT request form and payment receipt with you to the collection centre.

For a current list of our centres, please visit clinicallabs.com.au/location.

Please note: Harmony NIPT is available from 10 weeks in pregnancy. 

When will the results be available?

Results will be with your referring doctor 5-10 business days after receipt of the sample at our labs.

Please be advised:
•    If your referring doctor or you, as the patient, add fetal sex after the initial Harmony test results are provided, the additional reporting for fetal sex will be available to your referring doctor within 48-72 hours.  
•    In the case of late payments for the Harmony NIPT test, reports will be provided to your referring doctor within 48-72 hours. Please note that results cannot be provided on-the-spot. 

What is 22q11.2 microdeletion (DiGeorge syndrome)?

22q11.2 microdeletion is the absence of a small piece of chromosome 22 1 and is named by the area of the chromosome that is absent. This occurs in about 1 in 1,000 pregnancies 2,3. The Harmony test looks for 22q11.2 microdeletion, the most common genetic cause of heart defects and intellectual disability after Down syndrome 4, and the underlying cause of DiGeorge and Velocardiofacial syndromes (VCFS).

Please note: 22q11.2 microdeletion can only be performed in singleton pregnancies.

References:

  1. Schmid et al. Fetal Diagn Ther 2017; Doi:10.1159/000484317.
  2. Grati et al. Prenat Diagn 2015;35:801-809.
  3. Wapner et al. N Engl J Med 012;367:2175-2184.
  4. McDonald-McGinn et al. Gnet Med.2001 Jan-Feb:3(1):23-9.
Does Clinical Labs offer 22q11.2 microdeletion (DiGeorge syndrome) testing?

Yes, this is an additional testing option with Harmony NIPT, incurring an additional cost of $70. Your doctor cannot order 22q11.2 microdeletion (DiGeorge syndrome) testing on its own. 22q11.2 microdeletion can only be ordered with Harmony NIPT.

Is Harmony NIPT performed in Australia?

Yes. Clinical Labs is the only Australian provider of Harmony NIPT testing and it's performed in our state-of-the-art Molecular Genetics Laboratory.

Is genome-wide non-invasive prenatal testing (GW NIPT) recommended?

The Human Genetics Society of Australasia (HGSA) and RANZCOG do not recommend genome-wide prenatal screening. In their updated 2018 guidelines they state that "routine population-based screening for genome-wide chromosome abnormalities are not recommended due to the absence of well-performed clinical validation studies".

Why did my test fail?

In a small percenatge of cases (~2.0%), it will not be possible to generate a Harmony Prenatal Test result. This could be due to:

  • not enough fetal DNA in the blood (low fetal fraction, <4%)
  • high BMI of the mother
  • age of the mother
  • quality of the sample.

If your first test does not produce a result, you will be asked if you would like to provide a new blood sample for testing. If you choose not to proceed, you are entitled to a full refund. If you decide to supply a new sample for testing, there will be no additional cost to you, and it will be covered by your initial payment.

Some samples work upon repeat collection, but in a small number of patients (0.5-3%), it is not possible to generate a result*. If the second sample does not produce a conclusive result, then a cost recovery may be charged to you. This partial refund will be processed automatically upon a second time fail. Any refund issued by Australian Clinical Labs will be processed within 2-3 weeks back to the credit card used to pay at the initial testing stage.

For pregnant women who still wish to undergo the test for a third time, a full test fee will be incurred, and there will be no entitlement to a refund if the test fails.

*These women should discuss other methods for screening their pregnancy with their health care provider.

My test failed – can I get a refund?

In a small percentage of cases, it will not be possible to generate a Harmony Prenatal Test result. 

If your first test does not produce a valid result for Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), or Patau syndrome (trisomy 13), you will be asked if you would like to provide a new blood sample for testing. If you choose not to proceed, you are entitled to a full refund. If you decide to supply a new sample for testing, there will be no additional cost to you, and it will be covered by your initial payment.

If the second sample does not produce a conclusive result, then a cost recovery may be charged to you. This partial refund will be processed automatically upon a second time fail. Any refund issued by Australian Clinical Labs will be processed within 2-3 weeks back to the credit card used to pay at the initial testing stage.

For pregnant women who still wish to undergo the test for a third time, a full test fee will be incurred, and there will be no entitlement to a refund if the test fails.

The primary purpose of Harmony NIPT is to screen for the most common chromosomal abnormalities, which include Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), and Patau syndrome (trisomy 13). If the test fails to produce a result for T21, T18, and T13, a refund will be processed. "Inconclusive" results for the optional extras of the test, such as fetal sex and sex chromosome aneuploidies provided at no additional cost, will not be eligible for a refund, as the main autosomal aneuploidies have been reported.

What about false results?

Harmony NIPT is a highly accurate prenatal screening test with high specificity and sensitivity. It is important to note that it is not a diagnostic test, and while rare, false positive and negative results may occur.

When is NIPT not an option?

Sometimes, NIPT is not an option for screening a pregnancy. Reasons include pregnancies with more than two fetuses, pregnancies where an empty sac can be identified or with some maternal conditions. In addition, pregnant women whose test samples failed twice should seek another screening method for Down syndrome.

What if I have twins?

Twin pregnancies requesting the Harmony prenatal test will have an assessment for trisomies 21, 18 and 13 and a single result will be reported for the pregnancy. On request, fetal sex can be reported for the pregnancy.

Please note: The additional fetal sex chromosome analysis and 22q11.2 microdeletion can only be performed in singleton pregnancies.

I asked to find out the gender of my baby but the test came back inconclusive. Why did that happen?

While in more than 99% of cases, the reported fetal sex is accurate, there are rare occasions where a discrepant result may occur due to chromosomal or biological reasons in the fetus and the mother. It’s important to note that determining fetal gender is not the main purpose of the test. In some samples, it is not possible to obtain a conclusive result of the fetal sex, and repeat testing is typically unsuccessful. As this is a free add-on to the test and other diagnostic results have been provided, we cannot offer a refund or a free repeat.