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Basel,
12 January 2006
LightCycler SeptiFast Test is self declared for
CE Mark – faster results in diagnosis of “blood
poisoning”
Roche today announced that its new LightCycler SeptiFast
Test has received CE Mark (“Conformitée Européenne”),
allowing Roche Diagnostics to sell the test for
diagnostic use in the European Union. The LightCycler
SeptiFast Test can rapidly and reliably detect and
identify 25 different sepsis-causing pathogens –
including bacteria and fungi – which cause approximately
90 percent of all sepsis cases. This new test opens
up a whole new dimension in sepsis diagnosis as
rapid initiation of targeted treatment is crucial
in this condition.
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LightCycler
SeptiFast Test
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Over
18 million cases of severe sepsis occur each year.
According to epidemiological studies, severe sepsis
accounts for up to 135,000 European and 215,000 American
deaths each year. In Germany, severe sepsis accounts
for up to 60,000 deaths each year, a figure that makes
this condition the third leading cause of death in
Germany after coronary heart disease and acute myocardial
infarction. Despite improvements in its medical management,
sepsis still constitutes one of the greatest challenges
in intensive care medicine.
Micro-organisms responsible for causing sepsis are
traditionally detected in hospital laboratories with
the aid of microbiological culture methods which are
very time-consuming, generally taking from two to
five days to complete, and up to eight days for the
diagnosis of fungal infections. By contrast, the LightCycler
SeptiFast Test offers the advantage of being able
to detect and identify the sepsis pathogens in less
than 6 hours – an important time saving for targeted
medical treatment. Only after pathogens are correctly
identified can targeted therapy using a specific antibiotic
begin.
“We are very pleased that we can offer physicians
this new test and support their efforts to fight this
life-threatening infection. Combining the latest PCR
technology and our know-how in molecular diagnostics
has allowed us to rapidly develop this potentially
life-saving test. I am confident that many patients
will greatly benefit from it,” states Severin Schwan,
CEO Division Roche Diagnostics and Member of the Corporate
Executive Committee of Roche.
About the LightCycler SeptiFast Test
The LightCycler SeptiFast Test can detect several
pathogens simultaneously from just one blood sample.
Three millilitres of whole blood are sufficient –
even if the collected sample only contains minute
quantities of pathogen DNA. It can even be used to
identify bacteria that have already been treated with
antibiotics and that therefore would not be detectable
by traditional culture methods. The test operates
on the basis of the Polymerase Chain Reaction (PCR).
This method is used to copy repeatedly specific sequences
from the genetic material of the pathogen (deoxyribonucleic
acid, DNA) so that even small initial quantities can
be clearly identified. From the technical standpoint,
the LightCycler SeptiFast Test is implemented on the
LightCycler 2.0 and is characterized by the MGRADE
quality of its reagents. Practically speaking, these
are free of any contamination with microbial genetic
material that would compromise the reliability of
the results. Additional information is available on
the Internet.
About Roche
Headquartered in Basel, Switzerland, Roche is one
of the world’s leading research-focused healthcare
groups in the fields of pharmaceuticals and diagnostics.
As a supplier of innovative products and services
for the early detection, prevention, diagnosis and
treatment of diseases, the Group contributes on a
broad range of fronts to improving people’s health
and quality of life. Roche is a world leader in diagnostics,
the leading supplier of drugs for cancer and transplantation
and a market leader in virology. Roche employs roughly
65,000 people in 150 countries and has R&D agreements
and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group is available
on the Internet at http://www.roche.com/.
All trademarks used or mentioned
in this release are protected by law.
Further information:
- Roche Diagnostics |
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