Actionable results you can trust

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Clinical Labs is proud to be the exclusive Australian provider of Harmony NIPT, the most accurate non-invasive prenatal test, including 22q11.2 microdeletion.

The Harmony® prenatal test is a DNA-based blood screening test for the most common chromosomal abnormalities, including Down syndrome. Harmony is more accurate than traditional tests and can be performed as early as 10 weeks into pregnancy with just a simple blood test 1,2.

Harmony is a highly accurate test, with clinical testing demonstrating its ability to identify over 99% of Down syndrome cases and maintain a false-positive rate of less than 0.1% 1,2. In comparison, combined first trimester screening (cFTS) can detect 85-90% of pregnancies with trisomy 21 and has a higher false-positive rate of 3-5%2. Clinicians in more than 100 countries have trusted Harmony 3.

The Royal College of Obstetricians and Gynaecologists (RANZCOG) along with the Human Genetics Society of Australasia (HGSA) recommend that NIPT antenatal screening be discussed with all pregnant women (and their partners) so that they can make an informed decision as to whether to proceed with testing 4.

Australian Clinical Labs is NATA accredited for the Harmony Non-Invasive Prenatal Testing (NIPT), and all analysis is conducted in Australia – allowing for high accuracy and quick result turnaround times. Patient’s results will be available 5-10 business days from sample receipt at our labs.

As payment is required before collection, please advise patients to scan the QR code on their request form or visit pay.clinicallabs.com.au/harmony to pay for their test online.

References:

  1. Stokowski et al. Prenat Diagn. 2015;35:1-4.
  2. Demonstrated by 72 peer-reviewed published studies using the Harmony prenatal test as of Jan 2021.
  3. Norton et al. N Engl J Med. 2015 Apr 23; 372(17): 1589-97.
  4. RANZCOG Guideline (C-Obs59) July 2018.
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Getting Started

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What is Non-Invasive Prenatal Testing (NIPT)?

NIPT involves testing millions of short fragments of DNA in maternal plasma. Some of these fragments will have come from the placenta, and most will be from the mother.

Using state-of-the-art cell-free DNA (cfDNA) technology, the Harmony® NIPT test can be performed as early as 10 weeks’ gestation and carries a >99% accuracy rate for Down syndrome with a low false positive rate of 0.1% 3. NIPT reduces the need for invasive diagnostic testing and thus the risk of procedure-related miscarriage. Compared to conventional screening tests, NIPT is the most accurate and specific screening test with higher detection rates of chromosomal aneuploidies, including Trisomy 21, 18, and 13 1,2,3.

References:

  1. Stokowski et al. Prenat Diagn. 2015 Dec; 35(12): 1243-1246.
  2. Demonstrated by 59 peer reviewed published studies using the Harmony prenatal test as of Jan 2019.
  3. Norton et al. N Engl J Med. 2015 Apr 23; 372 (17): 1589-97.

 

Harmony® – Actionable Results You Can Trust

Harmony is not like other trisomy screening tests. Its methodology is different and provides you and your patients with a greater level of assurance 1-3.

Harmony is the most broadly studied non-invasive prenatal test (NIPT) for Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), and Patau syndrome (trisomy 13) 4. The Harmony prenatal test uses a proprietary, targeted DNA-based technology to provide you and your patients with a greater level of assurance, simply requiring a maternal blood sample 1-3. NIPT not only screens for trisomy 21, 18, and 13, but it can also evaluate foetal sex, sex chromosomal aneuploidy conditions, and 22q11.2 deletion syndrome.

References:

  1. Norton et al. N Engl J Med. 2015 Apr 23; 372 (17): 1589-97.
  2. Sparks et al. Prenat Diagn. 2012 Jan; 32(1): 3-9.
  3. Juneau et al. Fetal Diagn Ther. 2014. 36(4): 282-6.
  4. Demonstrated by 72 peer-reviewed published studies using the Harmony prenatal test as of Jan 2021.
 

Suitable for Women of any Risk Category*

The Harmony prenatal test has been demonstrated in studies involving >268,000 women in >72 peer-reviewed publications1.

The Harmony prenatal test was developed to be a more accurate prenatal Down syndrome screening test, is validated for use in women ≥ 18 years, and is suitable for women of any risk category*. It is a DNA-based blood test that has been extensively tested in both the under 35 and over 35 age groups, and studies have included pregnant women ages 18-48 for trisomy 21 2.

The Harmony test has been studied in more scientific publications than any other cell-free DNA-based prenatal test 1. Performance of the Harmony test has been extensively demonstrated in both singleton and twin pregnancies, in women ≥ 18 years and women of any risk category* 2,3,4,5. Other peer-reviewed studies have evaluated clinical implementation 6 and the accuracy and reproducibility of the Harmony fetal fraction assessment 7.

For more information, please click here.

References:

  1. Demonstrated by 72 peer-reviewed published studies using the Harmony prenatal test as of Jan 2021.
  2. Norton et al. Am J Obstet Gynecol.2012 Aug;207(2):137-8.
  3. Stokowski et al. Prenat Diagn. 2015 Dec;35(12):1243-1246.
  4. Nicolaides et al. Am J Obstet Gynecol.2012Nov;207(5):374.e1-6.
  5. Gil et al. Fetal Diagn Ther.2014;35:204-211.
  6. Kagan et al. Ultrasound Obstet Gynecol.Sep 19. doi:10.1002/uog.18905.
  7. Schmid et al. Ultrasound Obstet Gynecol. 2018; doi:10.1002/uog.19036.

*Any risk refers to the average risk population (age < 35) and high risk population (age > 35).

 

A More Accurate Test

Harmony has been shown in clinical testing to identify greater than 99% of Down syndrome cases and to have a false-positive rate of less than 0.1%. In comparison, combined first trimester screening (cFTS) can detect 85-90% of pregnancies with trisomy 21 and has a higher false-positive rate of 3-5%2.

The Harmony test consistently delivers industry-leading performance for trisomy 21, trisomy 18, and trisomy 13 across clinical studies, with higher detection rates and lower false-positive rates for trisomy 21 compared to traditional tests 1.

For more information, please click here.

 

Clarity Early

The Harmony prenatal test requires a single blood draw and is ideally performed between 10+ and 14 weeks' gestation. Results are available 5-10 business days after sample receipt. Other commonly used screening tests for Down syndrome are performed later in pregnancy and may require multiple office visits.

Harmony NIPT can also be offered for Down syndrome screening in the 2nd and 3rd trimester, if the patient missed the screening during the first trimester.   

 

Minimises Need for Follow-up Tests

The greater accuracy and low false-positive rate of Harmony compared to traditional tests may minimise the chance that further testing is recommended due to a false-positive result. This reduces the chance of needing an invasive procedure, such as amniocentesis.

The Harmony test menu focuses on clinically relevant conditions, minimising overall false-positive rates. “More” is not necessarily “better”. Other NIPT labs offer testing for panels of rare syndromes with limited medical value. Each condition tested has an associated false-positive rate and adds to the total false-positive rate of the test.

Harmony focuses on clinically relevant conditions and provides flexibility to order only the tests that are appropriate in a given situation, addressing the conditions that are likely to be of greatest concern for patients and clinicians.                                                                                                                                                                                    

 

If you require further information about testing or need to discuss a patient, please contact:
Assoc. Prof. Mirette Saad on P: (03) 9538 6777 or E: Mirette.Saad@clinicallabs.com.au.

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