PrenaTest®

Non-invasive examination for the determination of the fetal trisomies 21, 18 und 13 such as Klinefelter syndrome, Turner-, Triple X-, XYY syndrome and a 22q11.2 microdeletion (associated with DiGeorge syndrome)

Starting from the ninth week of pregnancy (9+0 weeks since LMP) the PrenaTest® determines trisomies 21, 18 and 13, gonosomal aneuploidies (Turner, triple X, Klinefelter, and XYY syndromes) as well as the 22q11.2 microdeletion (associated with the DiGeorge syndrome) from maternal blood. If desired, the gender of the fetus may also be determined. The PrenaTest® can also be performed in the case of a twin pregnancy, following fertility treatment – as well as egg donation.

 

With the PrenaTest®, you can fully implement the recommendations of medical associations in Germany, Austria and Switzerland, as it offers the appropriate test panel.

Did you know that…

… NIPT is recommended as a primary screening method for all pregnant women?1.With the PrenaTest® option 1, you can implement this recommendation cost-efficiently for your patient.

 

1 Schmid M et al. Cell-Free DNA Testing for Fetal Chromosomal Anomalies in clinical practice: Austrian-German-Swiss Recommendations for non-invasive prenatal tests (NIPT).

Ultraschall in Med 2015; 36:507-510

Reliable

> 99% Detection rate
0,1% False positive rate
< 0,6% No call rate
Applicable under LMWH therapy

Rapid

Test results from the second day

Safe

In accordance with the In-Vitro Diagnostic Directive 98/79/EC since 2012
Worldwide first NIPT with CE-marked data analysis software
Patent licence of Sequenom Inc. (USA)

Depending on the medical question, choose between three test options

Can be used in the case of/ following
PrenaTest® Option 1
Trisomy 21,
gender determination
PrenaTest® Option 2
Trisomies 21, 18, 13,
gender determination
PrenaTest® Option 3
Trisomies 21, 18, 13,
Maldistributions of the sex chromosomes,
22q11.2 microdeletion,
gender determination
Single pregnancy
Twin pregnancy
All fertility treatmens
(IVF, ICSI etc.)
Test result for option 1 usually in 2 – 6 business days**.
Test result for Option 2 & 3 usually in  4 – 6 business days**.
Reasons for PrenaTest®

Further clarification of common screening methods, thus reduction of the number of unnecessary invasive examinations.

Comparison of screening methods

Detection rates of screening methods for the determination of fetal trisomy 21 compared to PrenaTest®
1 Internal data from lab routine and clinical data.
2 Cuckle H, Benn P, Wright d (2005). Down syndrome screening in the first and / or second trimester: model predicted performance using meta-analysis parameters. Seminars in Perinatalogy 29,252-257.


 

Use of two technologies according to the individual requirement

The new, innovative qNIPT method is based on a quantitative real-time PCR (qPCR) and assures a cost-efficient and rapid analysis. It is currently used for the PrenaTest® Option 1 to determine fetal trisomy 21. The method of random massively parallel sequencing (rMPS) has already been firmly established worldwide for NIPT and is used to determine a wide range of fetal aneuploidies.

New and innovative – qNIPT

Developed by LifeCodexx AG, the new qNIPT assay is based on a quantitative real-time PCR (qPCR). Due to different methylation patterns in specific gene regions of the maternal and fetal DNA, positive and negative samples are reliably classified. In addition, the proportion of cell-free fetal DNA (cffDNA) to the total amount of cell-free maternal and fetal DNA (cfDNA) is determined.

Well established – rMPS

With the method of random massively parallel sequencing (rMPS), the cell-free DNA is decoded with the most modern analytical equipment. The objective is to determine whether the quantity of sequences for the respective chromosome under investigation exceeds the normal range found in the case of a euploid, i.e. normal, chromosome set. It is the most widely used NIPT technology worldwide to date and has been validated in numerous studies.


Measurement of the fetal fraction right after sample receipt

The doctor will be notified the next day following receipt of the blood sample if the total amount of cell-free fetal DNA (cffDNA) is not sufficient, and if the level of cffDNA is too low compared to the total level of cell-free maternal and fetal DNA (cfDNA). Thus, the waiting time for the patient is reduced to a minimum in the event that a repetition of the analysis is necessary. The total quantity is cruicial for the qNIPT method, whereas for rMPS both quality criteria are significant.

 

The first NIPT prospective clinical follow-up study in Germany

According to the European guidelines for medical devices, the PrenaTest® was evaluated in the context of a prospective clinical follow-up study in Germany, which included over 2.200 patients with singleton pregancy. Final results demonstrate a sensitivity and specificity of 100% for the fetal trisomy 21.1

 

1 Floeck A et al. Non-invasive Prenatal Testing (NIPT). Europe´s first multicenter Post Market Clinical Follow-Up Study Validating the Quality in Clinical Routine. Arch Gynecol Obstet (2017). https://doi.org/10.1007/s00404-017-4517-3

 

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