Re: Roche sepsis test approved in EU

[Guest guest]

Basel, 12 January 2006

Roche's rapid sepsis test now available in the European Union

http://www.nieuwsbank.nl/en/2006/01/12/r013.htm

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.

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

www.roche.com .

All trademarks used or mentioned in this release are protected by

law.

Further information:

- Roche Diagnostics

LightCycler SeptiFast Test

--- In , " tigerpaw2c " <tigerpaw2c@y...>

wrote:

>

> Roche sepsis test approved in EU

> 01.12.2006, 02:05 AM

>

> http://www.forbes.com/markets/feeds/afx/2006/01/12/afx2444527.html

>

> ZURICH (AFX) - Roche Holding AG's diagnostics unit said that its

> sepsis test, known as the LightCycler SeptiFast Test, has has

> received the CE Mark, allowing the Swiss firm to sell the test in

> the European Union.

>

> It can detect and identify 25 different sepsis-causing pathogens -

> including bacteria and fungi - which cause approximately 90 pct of

> all sepsis cases, Roche said.

>

> Over 18 mln cases of severe sepsis occur each year, and severe

> sepsis accounts for up to 135,000 European and 215,000 American

> deaths each year, according to epidemiological studies.

>

[Guest guest]

Thank god for this- at least there will be a quicker test that can be used, IF

the dang drs

will bother to use them. Around here, they don't seem to test very often, they

just grab

that old pad and start writing.

I wonder if the reliabilty is as good as the slow tests.....or how many false

pos/negs there

are.

>

> Basel, 12 January 2006

>

> Roche's rapid sepsis test now available in the European Union

> http://www.nieuwsbank.nl/en/2006/01/12/r013.htm

>

>

> 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.

>

> 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

> www.roche.com .

>

> All trademarks used or mentioned in this release are protected by

> law.

>

> Further information:

> - Roche Diagnostics

>

> LightCycler SeptiFast Test

[Guest guest]

Hi :

I was thinking the same and could have used this test in December when I had

an emergency hospitalization for sepsis and major kidney infection. Rather

than having to wait 3 days for the culture the doctors would have know

within a day. No they didn't just grab a pad and start writing, they hooked

me up to IV antibiotics and others to save my life until they had a DX from

the cultures and then we switched to the specific Rx therapy.

Rosie

[] Re: Roche sepsis test approved in EU

Thank god for this- at least there will be a quicker test that can be used,

IF the dang drs

will bother to use them. Around here, they don't seem to test very often,

they just grab

that old pad and start writing.

I wonder if the reliabilty is as good as the slow tests.....or how many

false pos/negs there

are.