...
....
Pharmaceutical
Biotechnology

> See specialized channels
Medical Devices & Diagnostics
> See specialized channels
Industrial
Biotechnology
> See specialized channels


  Join us

  Follow us on Twitter   Join our LinkedIn Group   Our Blog

Biotech News App
Provides access to the latest biotech press releases ...more

Android_Logo App Store RIM_Logo_small

Media Partnership:
Want to have your RSS feed integrated on our website? Contact us
RSS Feeds RSS Feeds
JoomlaWatch Stats 1.2.9 by Matej Koval
For Editors
Sign up for press releases
For Companies
Sign up for our newsletter
Back to PRESS RELEASES - 

GATC Biotech and LifeCodexx Complete Recruitment of Blood Samples for Clinical Study of Trisomy 21 Diagnostic Test

| Print |
Tuesday, 10 January 2012 09:15 (UTC + 1)
GATC_Biotech_logo2 Lifecodexx_Logo

Results of study to be available in the first quarter 2012

Constance, Germany, 10 January 2012 / B3C newswire / - GATC Biotech AG and its subsidiary LifeCodexx AG successfully completed the recruitment of over 500 blood samples required for the clinical study of the non-invasive prenatal diagnostic test for the determination of trisomy 21 (LifeCodexx PraenaTest™). The prospective and blinded study evaluates this new molecular genetic method in comparison with conventional invasive methods and is based on the Next Generation sequencing of cell-free fetal DNA from maternal blood.

For the first time ever multiplexing the analysis on an Illumina HiSeq 2000 could be increased from previously seven to now twelve samples leading to increased cost efficiency. In addition, blood sampling and shipping was simplified, as the physician is no longer required to prepare the blood plasma before shipping and can now send the sample at ambient temperature.

The results of the study will be available in the first quarter of 2012. Then, following CE certification, the LifeCodexx PraenaTest™ will initially be introduced in German speaking countries in the second quarter of the year.

“We are very pleased to have the sample recruitment completed within six months. We sincerely thank all participating women and physicians for their support of the evaluation of this new diagnostic method,” said Dr. Michael Lutz, CEO of LifeCodexx AG. “We are very confident that the study will achieve the same positive results of previous pilot studies with regard to specificity and sensitivity. Then we will be able to offer a very reliable and safe diagnostic test to many women with high risk pregnancies, saving them from invasive prenatal methods.”

The clinical study was conducted jointly with several Central European prenatal diagnostics centers and scientists at GATC Biotech AG and LifeCodexx AG. Currently, the only reliable way of diagnosing chromosomal irregularities during pregnancy is to use invasive prenatal methods. This causes miscarriage in about one per cent of these risky surgical procedures.

 
Contacts

Elke Decker
GATC Biotech AG
Director Strategic Marketing & Corp Comm
+49 (0) 7531-816030
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Dr. Michael Lutz
LifeCodexx AG
Chief Executive Officer
+49 (0) 7531 81 60 15
This e-mail address is being protected from spambots. You need JavaScript enabled to view it