Harmony® Test laboratory analysis requires only 3 working days

For pregnant women and their families, waiting for the results of a prenatal test is often a huge mental burden. We are pleased to inform you that Cenata has reduced the analysis time for the Harmony® Test by 25% – to just three working days in average. This means that the results of the Harmony® Test are now usually available to the requesting physician within 3 working days.

The time required for analysis has been shortened by working in a shift system which allows us to run analyses daily. The laboratory analysis of the Harmony® Test comprises the following steps that result in the high sensitivity and specificity of the Harmony® Test:

"Procedure

In some cases it can still happen that the test must be repeated for technical reasons. In case of a delay the requesting physician will be informed immediately that the reporting will be delayed by about three days.

The decreased reporting time does not influence the high quality and validity of the Harmony® Test. Nothing in the test design is changed. Of course, the improvement in processing time does not result in any additional costs for the patient.

Please contact us if you have any questions.

Harmony® Test CE certified

The FORTE (Fetal-fraction Optimized Risk of Trisomy Evaluation Dynamic Linked Library) software is a cornerstone of the Harmony® Test. It enables the analysis of fetal cell-free DNA (cfDNA) from the maternal plasma, in order to determine the gender of the fetus, the risk for trisomy 21, 18 and 13 and for X and Y chromosomal aneuploidies.

Cenata confirms that the FORTE algorithm, which is being used as part of the Harmony® Test, is CE marked in accordance with the European IVD guidelines (directive 98/79/EC; annex II, list B).

The Harmony® Test is the only NIPT performed in Germany, whose algorithm is CE certified for all chromosomal abnormalities under investigation.

The blood collection tubes which are provided as part of the Harmony® Test are also CE certified by the manufacturer.

Harmony® Test is not influenced by guanine-cytosine content of a sample

The Harmony® Test specifically analyses pre-defined and carefully selected sequences of the chromosomes in question by means of the DANSR (Digital Analysis of Selected Regions) technology1. Other NIPT methods based on the rMPS (random massively parallel sequencing) method (e.g. PraenaTest®, Praenatalis-Test®), sequence randomly selected sequences of free DNA.

The random sequencing employed in rMPS methods is susceptible to a shift of the so-called GC distribution. This is caused, amongst other things, by treatment with low-molecular weight heparin 2,3. This is why an LMWH treatment in conjunction with the rMPS method can lead to increased test failures and to a higher number of false positive and false negative results 4.

The DANSR method used in the Harmony® Test thus has three advantages:

  1. the sequences that are examined and thus their GC distribution are pre-defined and hence are not affected by the pregnant woman’s heparin treatment,
  2. the fetal DNA fraction is analysed independent of the GC content5 and
  3. the greater sequencing depth in the chromosomes in question ensures greater security and a lower susceptibility to interference.

 

  1. Sparks AB, Wang ET, Struble CA, Barrett W, Stokowski R, McBride C, Zahn J, Lee K, Shen N, Doshi J, Sun M, Garrison J, Sandler J, Hollemon D, Pattee P, Tomita-Mitchell A, Mitchell M, Stuelpnagel J, Song K, Oliphant A. Selective analysis of cell-free DNA in maternal blood for evaluation of fetal trisomy. Prenat Diagn. 2012 Jan;32(1):3-9. doi: 10.1002/pd.2922.
  2. Chiu RW, Sun H, Akolekar R, Clouser C, Lee C, McKernan K, Zhou D, Nicolaides KH, Lo YM. Maternal plasma DNA analysis with massively parallel sequencing by ligation for noninvasive prenatal diagnosis of trisomy 21. Clin Chem. 2010 Mar;56(3):459-63. doi: 10.1373/clinchem.2009.136507.
  3. Fan HC, Quake SR. Sensitivity of noninvasive prenatal detection of fetal aneuploidy from maternal plasma using shotgun sequencing is limited only by counting statistics. PLoS One. 2010 May 3;5(5):e10439. doi:10.1371/journal.pone.0010439.
  4. Lutz M, Lifecodexx Newsletter March 2015
  5. Sparks AB, Struble CA, Wang ET, Song K, Oliphant A. Noninvasive prenatal detection and selective analysis of cell-free DNA obtained from maternal blood: evaluation for trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012 Apr;206(4):319.e1-9. doi: 10.1016/j.ajog.2012.01.030.