HENNIGSDORF, Germany, July 17 -- The Fetal Medicine Foundation (FMF) confirmed
that BRAHMS KRYPTOR compact is fulfilling the requirements for first trimester
biochemical screening.

Non-invasive biomarker tests together with the measurement of nuchal
translucency (NT) allow the risk assessment of Down’s syndrome without
jeopardising the fetus. Especially pregnant women under the age of 35 benefit
from this approach. Ten years ago the Fetal Medicine Foundation (FMF) certified
the BRAHMS KRYPTOR and took it into clinical routine as the first automated
laboratory system for quality-assured combined first trimester screening. Now
the compact version of the KRYPTOR follows. Professor Kevin Spencer from the
King George Hospital in Essex conducted an evaluation of the first trimester
Down’s screening assays Free sshCG and PAPP-A on the BRAHMS KRYPTOR
compact. Based on this study he concluded that results from both systems are
interchangeable and screening performance is equally. Thus both platforms will
use the same set of medians.

Medians are established over a long period of time and their stability is
important to maintain an effective screening program. Since it has been
established - because the KRYPTOR compact and KRYPTOR use exactly the same
reagent system - the medians on each machine are interchangeable and therefore
any lab wishing to change to compact would not need to re-evaluate medians. This
has never been possible with any other analytical platform before, explained
Professor Spencer, who also serves as Director of Biochemical Screening of the
Fetal Medicine Foundation (FMF).

Laboratories starting with KRYPTOR compact newly, can expect that the screening
performance using KRYPTOR compact will be equally as good as that which has been
achieved with KRYPTOR over the past 10 years.

Trisomy 21 or Down’s syndrome is one of the most common genetic
abnormalities affecting one in every 700 births worldwide. The risk of
chromosomal defects like Trisomy 21 increases with maternal age, but decreases
with gestational age. Non-invasive testing allows all pregnant women to assess
their individual risk without having to submit to invasive testing which is
associated with a certain risk of miscarriage of about 1%. Non-invasive risk
assessment requires high precision and accuracy in the measurement of the
biochemical markers, as well as for the measurement of the nuchal translucency.
For the BRAHMS markers Free sshCG and PAPP-A, KRYPTOR fulfils these requirements
in an exceptional way, making KRYPTOR - and now KRYPTOR compact - the instrument
of choice for 1st and 2nd trimester screening.

The evaluation was carried out over a six week period from March to April 2009
performed on one KRYPTOR compact and two KRYPTOR classic machines. To assess
medians the research team used a group of 400 samples from Caucasian, non
smoking women with a singleton pregnancy and with gestations in the range 10+0
to 13+6 weeks. The KRYPTOR compact medians are very close to the current FMF
calculated median for KRYPTOR classic and suggest that deriving new medians for
the new platform should not be necessary. The clinical utility of KRYPTOR and
KRYPTOR compact was compared in a case control study in some 70 cases of known
Trisomy 21. Both analytical platforms perform with excellent precision, the
medians of KRYPTOR compact highly correlate with those established by the Fetal
Medicine Foundation (FMF) using KRYPTOR in their routine from 1998 on.

The BRAHMS Aktiengesellschaft conducts researches, develops, produces and
markets innovative diagnostic biomarkers. It is one of the three largest
biotechnology companies in Germany. The company sells its products in more than
65 countries via its own subsidiary companies and sales organizations as well as
laboratory systems from its own production and globally operating licensees. The
headquarter of BRAHMS is at Hennigsdorf / Berlin, where about 220 out of 400 of
the world wide employees of the company are posted.

The Fetal Medicine Foundation (FMF) is a Registered Charity that aims to
improve the health of pregnant women and their babies through research and
training in fetal medicine. The Foundation, with the support of an international
group of experts, has introduced an educational programme both for healthcare
professionals and parents and a series of certificates of competence in
different aspects of fetal medicine. For further information visit

Contact: BRAHMS Aktiengesellschaft Ingo Buchholzer Public Relations Manager
Phone: +49 3302 883-637 Fax: +49-3302-883-635 Mobile: +49-172-323-4087 E-mail:


SOURCE: B R A H M S Aktiengesellschaft

Contact: BRAHMS Aktiengesellschaft, Ingo Buchholzer, Public Relations Manager,
Phone: +49 3302 883-637, Fax: +49-3302-883-635, Mobile: +49-172-323-4087,
E-mail: i.buchholzer@brahms.de