Aa
fibrosure
how accurate is a fibrosure test? Has anyone had one? Should I get a biopsy?
The Clinical Care Options website (which is a review/summary by professionals) says that Fibroscan tests a sample that is 1/500th of the liver. While that may be a lot better than the sample tested by a biopsy, it isn't much. I still believe that my FibroTC, based on tomographic images of the entire liver, is the best test of all (see my images pages for the full series of my test, both tomography and FibroTC analysis). Unfortunately, it is not yet commercially available outside Spain.
As to Fibroscan, well, I guess most Medhelpers know what recently happened to me: from a biopsy + FibroTC of F1 a year ago, to a Fibroscan of F3/F4 laast week! I wonder which one isn't telling the truth?!
Mike
As to Fibroscan, well, I guess most Medhelpers know what recently happened to me: from a biopsy + FibroTC of F1 a year ago, to a Fibroscan of F3/F4 laast week! I wonder which one isn't telling the truth?!
Mike
you are right that none of the tests are perfect but if you read the study data the FibroSCAN is not that accurate for the middle stages of fibrosis. almost the same as the FibroSURE. agree that all 3 tests used together could be used to get a good idea of liver damage. This of course with a good "Hepatologist" as your doctor.
Hi Bill,
The process of scarring of the liver (fibrosis) does not happen uniformly.
There was one example on the forum where some one got a biopsy with
a much lower reading only to find out a short while later that they had cirrhosis.
Apparently that doctor`s answer to the problem was to have to stab the liver
multiple times to get the best reading.Well I had a Fibroscan which computed a
result from 10 different readings done in 15min. How are you going to do this with
a biopsy. Truth of the matter is none of the 3 tests FibroSure,FibroScan,Biopsy
are 100 % but the FibroScan gets to be pretty accurate for overall picture.
If I hear the term "golden standard" one more time .......! Biopsy is not foolproof
if it were maybe we would not need pretentious explanations like that.
Bali05
The process of scarring of the liver (fibrosis) does not happen uniformly.
There was one example on the forum where some one got a biopsy with
a much lower reading only to find out a short while later that they had cirrhosis.
Apparently that doctor`s answer to the problem was to have to stab the liver
multiple times to get the best reading.Well I had a Fibroscan which computed a
result from 10 different readings done in 15min. How are you going to do this with
a biopsy. Truth of the matter is none of the 3 tests FibroSure,FibroScan,Biopsy
are 100 % but the FibroScan gets to be pretty accurate for overall picture.
If I hear the term "golden standard" one more time .......! Biopsy is not foolproof
if it were maybe we would not need pretentious explanations like that.
Bali05
very interesting post that Marc - I agree with you
Biopsy's may be considered "the best way" by some but even they can be wrong - someone on here said that they're biopsy was incorrect due to the sample been taken from a healthier section of the liver and therefore gave off improper results as the rest of the liver was quite damaged - whereas the Fibroscan is able to give you data from MORE of the liver than a Biopsy can (hundreds of times more).
Hepatits Researcher makes an interesting read above - I agree there that all / as many as possible shoudl be done to paint an overall picture of ones liver
Biopsy's may be considered "the best way" by some but even they can be wrong - someone on here said that they're biopsy was incorrect due to the sample been taken from a healthier section of the liver and therefore gave off improper results as the rest of the liver was quite damaged - whereas the Fibroscan is able to give you data from MORE of the liver than a Biopsy can (hundreds of times more).
Hepatits Researcher makes an interesting read above - I agree there that all / as many as possible shoudl be done to paint an overall picture of ones liver
I was tested fibrotest Mexico came in with a lower reading than the Firbroscan at 8.7 I beleive in my personal opinion they both serve a purpose and are harmless but the key is interpretation and it takes a very well trained person to read the fibroscan this is or maybe why the US is dragging it's feet in FDA approval in other countries it was much more readily accepted therefore many more techincians were educated on reading the fibroscan but like anything else some are better than others I hold HR in high regard
Baja
Baja
I assume that some of you saw the large scale study of a non-invasive approach to liver scaling as opposed to biopsy in a recent issue of Hepatology:
"SAFE biopsy: A validated method for large-scale staging of liver fibrosis in chronic hepatitis C" Hepatology, Vol. 9, issue 6, 2009 conducted by a group of Italian researchers.
It found insignificant diagnostic difference between the results of the non-invasive approach based on Fiibrosure plus an AST-to-platelet-ratio computation and the results from a biopsy. But I want to make another point:
The authors of that study point out the it is not economically feasible to use biopsies to treat the worldwide population with HCV. Given the size of that community and other stresses on medical systems, the non-invasive approach is a more sensible alternative because you can reach a much larger group of people with it.
Isn't this typical of the American health system and isn't this one of the reasons we are in trouble? Those American doctors and nurses who are saying biopsy or nothing aren't thinking about the cost/benefit relationship between the different testing methods. If twice as many people (or ten times as many people which is probably more likely) can afford the non-invasive approach and the results are roughly equivalent in the vast majority of cases, wouldn't the overall well being of the HCV community will be improved if the non-invasive approaches were widely used? I don't in fact believe that the American doctors and nurses who have been cited in this thread as strongly endorsing the biopsy as the only accurate way to approach liver damage grading are reliable. I think they have bought into certain social norms within their community. As with many other issues, they choose the more expensive alternative even if it doesn't have higher proven efficacy. This is the American approach to medical care.
"SAFE biopsy: A validated method for large-scale staging of liver fibrosis in chronic hepatitis C" Hepatology, Vol. 9, issue 6, 2009 conducted by a group of Italian researchers.
It found insignificant diagnostic difference between the results of the non-invasive approach based on Fiibrosure plus an AST-to-platelet-ratio computation and the results from a biopsy. But I want to make another point:
The authors of that study point out the it is not economically feasible to use biopsies to treat the worldwide population with HCV. Given the size of that community and other stresses on medical systems, the non-invasive approach is a more sensible alternative because you can reach a much larger group of people with it.
Isn't this typical of the American health system and isn't this one of the reasons we are in trouble? Those American doctors and nurses who are saying biopsy or nothing aren't thinking about the cost/benefit relationship between the different testing methods. If twice as many people (or ten times as many people which is probably more likely) can afford the non-invasive approach and the results are roughly equivalent in the vast majority of cases, wouldn't the overall well being of the HCV community will be improved if the non-invasive approaches were widely used? I don't in fact believe that the American doctors and nurses who have been cited in this thread as strongly endorsing the biopsy as the only accurate way to approach liver damage grading are reliable. I think they have bought into certain social norms within their community. As with many other issues, they choose the more expensive alternative even if it doesn't have higher proven efficacy. This is the American approach to medical care.
As noted above, the FibroSCAN hasn’t been approved by the U.S. FDA; and the machine/procedure is unavailable here in commercial form. There are several machines here for research purposes, but a U.S. citizen has to go abroad to get tested commercially—
Bill
Bill
Inaccuracy in medical diagnostics is NOT harmless. Clinicians use these to determine if costly and occasionally dangerous measures need to be undertaken; the notion of whether the test itself is harmless isn’t a factor here.
“You could checkyour liver status over and over with absolutely no harm.” So what?
This is my point; if the test is inaccurate, how would serial results yield better decision power?
Bill
“You could checkyour liver status over and over with absolutely no harm.” So what?
This is my point; if the test is inaccurate, how would serial results yield better decision power?
Bill
is this a USA thing? (no Fibroscan)
just Im in UK and they do them at my local hospital , I had one that came back as 3.3 (perfect score) but just 2 years before a biopsy showed I had mild-mod fibrosis and moderate swelling - so makes you wonder doesn't it?
I personally think ALL the tests should be administered as they can be used to paint an overall picture of ones liver state
I had Biopsy, Fibroscan, Ultrasound - but I never heard of Fibrosure blood tests until now
just Im in UK and they do them at my local hospital , I had one that came back as 3.3 (perfect score) but just 2 years before a biopsy showed I had mild-mod fibrosis and moderate swelling - so makes you wonder doesn't it?
I personally think ALL the tests should be administered as they can be used to paint an overall picture of ones liver state
I had Biopsy, Fibroscan, Ultrasound - but I never heard of Fibrosure blood tests until now
Mike,
You can get a Fibroscan in Boston but get this because it is part of a study you have
to have a biopsy first. It`s with Dr. Afdahl (spelling?)
There is all this talk about accuracy as a reason why Fibroscan is still not available
yet the bloodmarker test Fibrosure is available ??!!??
If you ask me this is all bull..... The machine is 100% harmless why is not available
to the public ? You could checkyour liver status over and over with absolutely no
harm . It is ridiculous. The machine costs about 80K.
I decided to go Dusseldorf (Germany).
Bali05
You can get a Fibroscan in Boston but get this because it is part of a study you have
to have a biopsy first. It`s with Dr. Afdahl (spelling?)
There is all this talk about accuracy as a reason why Fibroscan is still not available
yet the bloodmarker test Fibrosure is available ??!!??
If you ask me this is all bull..... The machine is 100% harmless why is not available
to the public ? You could checkyour liver status over and over with absolutely no
harm . It is ridiculous. The machine costs about 80K.
I decided to go Dusseldorf (Germany).
Bali05
thanks for that - I didnt know there was Fibro-type blood tests aswell as the scan... now I do :)
From what I have read I still don't think the FDA will approve it but in all fairness I had to post the following. If I may be wrong I will be the first to admit it. According to the following article it was just approved in Canada and the manufacture says it expects to be approved in the USA in 2010. Like I posted earlier their representive told me 2007 back in 06. I hope I'm wrong and it proves to be a reliable test. The following is from HCV Advocate:
Echosens: Canada Approves FibroScan(R) and its 3 Probes
http://in.sys-con.com
PARIS, FRANCE -- (Marketwire) -- 09/09/09 -- Echosens, the French high-technology company specializing in non-invasive diagnostics in hepatology, announced that it has obtained approval for FibroScan® and its 3 probes (Pediatric, Standard and for Obese patients) in Canada.
This innovative diagnostic technique, specific to the liver, measures in a quantitative and reproducible way the "degree of hepatic fibrosis", from children to adults, of all shapes and sizes. This non-invasive diagnostic method is a real revolution for liver diseases and their monitoring, a revolution that Canadian patients will be able to benefit from.
FibroScan®, a sure and non-invasive diagnostic technique
This authorization to participate in the Canadian market comes after the world launch of the new XL probe. Echosens will now be able to market FibroScan® and its 3 probes, a product commercially available since 2005 worldwide and selected by the community of hepatologists thanks to more than 200 independent publications. According to Richard Guillaume, CEO of Echosens, "With its non-invasive nature, its ease of use and its immediate results, FibroScan® has already revolutionized the medical practice of hepatologists in Europe and Asia, and is expected to experience the same success in Canada."
A major benefit for Canadian patients
In Canada, viral hepatitis C and alcoholic diseases are the principal causes of cirrhosis. With 240,000 chronically infected people and 5,000 new cases of hepatitis C per year, taking control of this disease constitutes a major public health issue for the country.
In addition, the testimony of specialist physicians on the appearance of emerging pathologies such as Non Alcoholic Steatosic Hepatitis (NASH), which is growing rapidly in this country, reinforce the use of FibroScan®.
Without diagnosis or adapted control, hepatic fibrosis develops in 30% of these patients and can lead to cirrhosis.
Approval for an international development strategy
Canadian approval is an important step in Echosens' development strategy, but other approvals will follow. "Our product was approved in China in 2008, today in Canada, we hope in Japan at the end of 2009, and in the United States in 2010. We will focus on metabolic diseases like steatosis, but also on the study of other organs thanks to VCTE(TM) "Vibration Controlled Transcient Elastography".
Echosens: Partner for diagnostic solutions in Hepatology
A French company founded in 2001 in Paris, Echosens is an international SME specializing in the field of hepatology. The company developed and manufactures the FibroScan® device, based on VCTE(TM) "Vibration Controlled Transcient Elastography". Echosens has changed hepatologists' clinical practices by making available to them a new tool for diagnosis and follow-up of liver diseases. Echosens dedicates a significant part of its activity to Research in order to develop new medical devices and to open up new medical perspectives. The company works in close cooperation with health professionals and patients' associations to facilitate therapeutic follow up of patients. To date, 645 FibroScan® devices have been installed worldwide, including 157 in France.
For more information: www.echosens.com
Contacts:
Echosens
Cecile Guiducci
International Marketing Director
+33 1 44 82 78 50
***@****
Echosens: Canada Approves FibroScan(R) and its 3 Probes
http://in.sys-con.com
PARIS, FRANCE -- (Marketwire) -- 09/09/09 -- Echosens, the French high-technology company specializing in non-invasive diagnostics in hepatology, announced that it has obtained approval for FibroScan® and its 3 probes (Pediatric, Standard and for Obese patients) in Canada.
This innovative diagnostic technique, specific to the liver, measures in a quantitative and reproducible way the "degree of hepatic fibrosis", from children to adults, of all shapes and sizes. This non-invasive diagnostic method is a real revolution for liver diseases and their monitoring, a revolution that Canadian patients will be able to benefit from.
FibroScan®, a sure and non-invasive diagnostic technique
This authorization to participate in the Canadian market comes after the world launch of the new XL probe. Echosens will now be able to market FibroScan® and its 3 probes, a product commercially available since 2005 worldwide and selected by the community of hepatologists thanks to more than 200 independent publications. According to Richard Guillaume, CEO of Echosens, "With its non-invasive nature, its ease of use and its immediate results, FibroScan® has already revolutionized the medical practice of hepatologists in Europe and Asia, and is expected to experience the same success in Canada."
A major benefit for Canadian patients
In Canada, viral hepatitis C and alcoholic diseases are the principal causes of cirrhosis. With 240,000 chronically infected people and 5,000 new cases of hepatitis C per year, taking control of this disease constitutes a major public health issue for the country.
In addition, the testimony of specialist physicians on the appearance of emerging pathologies such as Non Alcoholic Steatosic Hepatitis (NASH), which is growing rapidly in this country, reinforce the use of FibroScan®.
Without diagnosis or adapted control, hepatic fibrosis develops in 30% of these patients and can lead to cirrhosis.
Approval for an international development strategy
Canadian approval is an important step in Echosens' development strategy, but other approvals will follow. "Our product was approved in China in 2008, today in Canada, we hope in Japan at the end of 2009, and in the United States in 2010. We will focus on metabolic diseases like steatosis, but also on the study of other organs thanks to VCTE(TM) "Vibration Controlled Transcient Elastography".
Echosens: Partner for diagnostic solutions in Hepatology
A French company founded in 2001 in Paris, Echosens is an international SME specializing in the field of hepatology. The company developed and manufactures the FibroScan® device, based on VCTE(TM) "Vibration Controlled Transcient Elastography". Echosens has changed hepatologists' clinical practices by making available to them a new tool for diagnosis and follow-up of liver diseases. Echosens dedicates a significant part of its activity to Research in order to develop new medical devices and to open up new medical perspectives. The company works in close cooperation with health professionals and patients' associations to facilitate therapeutic follow up of patients. To date, 645 FibroScan® devices have been installed worldwide, including 157 in France.
For more information: www.echosens.com
Contacts:
Echosens
Cecile Guiducci
International Marketing Director
+33 1 44 82 78 50
***@****
Agree that the reason it has not been approved is because it is not that accurate in the middle stages.
It is no more accurate then the FibroSURE test.
It was a great idea but failed in the trials.
It will not become the "test of the future" like the new PI's. Pi's have hard data to back it up, the Fibroscan does not.
It is no more accurate then the FibroSURE test.
It was a great idea but failed in the trials.
It will not become the "test of the future" like the new PI's. Pi's have hard data to back it up, the Fibroscan does not.
Just what I think, Marcia. The reality may be something else. ; )
They had one at Shands and in St Louis and there is one in the east and HR had one as bill mentioned.
Knowing where they are in the USA may not help much however. Until the trial results are revealed there may even be a question as to the importance of the results.
I hope that the trial results are awesome, but it seems to me I've read mixed. We will see....
Nice to say hi to you.
Willy
They had one at Shands and in St Louis and there is one in the east and HR had one as bill mentioned.
Knowing where they are in the USA may not help much however. Until the trial results are revealed there may even be a question as to the importance of the results.
I hope that the trial results are awesome, but it seems to me I've read mixed. We will see....
Nice to say hi to you.
Willy
There was a clinical trial but the trial is over and I'm not sure anyone would scan you since they would no longer be compensated for the work. Until it has approval I'm not sure that you will be able to get one.
In that regard..... I don't know if it matters who may have one.
IF and when it is approved I think you'll see it many places. They have expected approval and if it's going to happen it could come soon. May be more info at fall AASLD.
best,
Willy
In that regard..... I don't know if it matters who may have one.
IF and when it is approved I think you'll see it many places. They have expected approval and if it's going to happen it could come soon. May be more info at fall AASLD.
best,
Willy
Once again...
FibroSure and fibrospect are blood tests available in the US (labcorp was mentioned above)
FibroScan, is a scanning device like an ultrasound, and it seems that it is only available in very few places in the US.... don't ask me where. It looks like they are not commercially available. HR uses one... Bill mentioned it above
FibroSure and fibrospect are blood tests available in the US (labcorp was mentioned above)
FibroScan, is a scanning device like an ultrasound, and it seems that it is only available in very few places in the US.... don't ask me where. It looks like they are not commercially available. HR uses one... Bill mentioned it above
So, please correct me if I'm wrong, but are are you saying that there are no imaging tests available in the US? Niether FibroScan or FibroSure nor anything else?
Thanks,
Mike H
Thanks,
Mike H
BACKGROUND: The aim of this study was to assess the diagnostic performances of liver stiffness measurement (LSM), ultrasonography (US) and their combined use in predicting the extent of hepatic fibrosis. METHODS: Consecutive patients with chronic hepatitis B (HBV) or hepatitis C virus (HCV) infections, with indications for liver biopsy, were prospectively enrolled. LSM was performed on the same day as biopsy. US scores, including assessment of liver surface, liver parenchyma, intrahepatic vessels and spleen index, were used to assess the degree of hepatic fibrosis. The pathological findings were used as a reference standard and diagnostic accuracy was assessed and compared. RESULTS: Three-hundred and twenty patients, including 199 men and 121 women, with a mean age of 50.8 years, were analyzed. There were 214 (66.9%) HCV patients, 88 (27.5%) HBV patients and 18 (5.6%) patients with both HCV and HBV. LSM correlated significantly with the hepatic fibrosis (F) scores, necro-inflammatory activity and US scores in multivariate analysis. The diagnostic accuracy of LSM is significantly superior to US, and equal to combined LSM with US, in the prediction of all HCV-related fibrosis scores. The cut-off value of LSM is 6 kPa for diagnosing F > =1, with a positive predictive value of 91%. Also, the cut-off value is 12 kPa for the prediction of cirrhosis, with a negative predictive value of 94%. CONCLUSIONS: LSM is useful for predicting hepatic fibrosis and excluding cirrhosis. A combination of LSM and US does not improve the accuracy in assessing hepatic fibrosis.
http://www6.miami.edu/ummedicine-magazine/departments/clinicalnotes3.html
This link says that fibroscan WILL likely get approval.
Willy
This link says that fibroscan WILL likely get approval.
Willy
Here is a utube on fibroscan.
http://www.youtube.com/watch?v=l_E4ZGmKooA
I thought that there had been a EASl presentation on it but haven't found the results yet. To summarize though, I think they lacked sufficient ability to differentiate staging, particularly in the middle ranges. I looks as though Fibroscan may not get FDA approval, if I recall correctly.
Like any means of testing though it may have it's strengths and weaknesses. I've heard reports that some peoples livers are not homogeneous and that it is possible to find a range of conditions; depending upon where one took the biopsy one might get varying staging assessments.
This may account for some people who seem to rapidly progress staging with relatively great speed. There are a few members here who have have had that and this could be one way it could explain their plight.
I don't claim to know the answer. It is also fair to say that blood values can vary. IF I were to take a few tylenols or have a heart attack prior to getting a fibrosSURE (bloodtest) it would skew a few markers and I would be likely be assessed a worse staging than was actually present.
No tests will be perfec, not even biopsy.
(lol; I say that autopsy is the *gold standard*). : )
There are and have been other discussions here of fibroscan and fibro- type blood tests such as Fibrosure. (use the board search engine)
best,
Willy
http://www.youtube.com/watch?v=l_E4ZGmKooA
I thought that there had been a EASl presentation on it but haven't found the results yet. To summarize though, I think they lacked sufficient ability to differentiate staging, particularly in the middle ranges. I looks as though Fibroscan may not get FDA approval, if I recall correctly.
Like any means of testing though it may have it's strengths and weaknesses. I've heard reports that some peoples livers are not homogeneous and that it is possible to find a range of conditions; depending upon where one took the biopsy one might get varying staging assessments.
This may account for some people who seem to rapidly progress staging with relatively great speed. There are a few members here who have have had that and this could be one way it could explain their plight.
I don't claim to know the answer. It is also fair to say that blood values can vary. IF I were to take a few tylenols or have a heart attack prior to getting a fibrosSURE (bloodtest) it would skew a few markers and I would be likely be assessed a worse staging than was actually present.
No tests will be perfec, not even biopsy.
(lol; I say that autopsy is the *gold standard*). : )
There are and have been other discussions here of fibroscan and fibro- type blood tests such as Fibrosure. (use the board search engine)
best,
Willy
copyman:
'the FibroScan machine is from a french company called Ehcosens. I don't think they will ever get FDA approval. After my conversation with one of their representives back in 2007 they said if they didn't have FDA by end of the year they would stop pursuing the USA market.'
Just wanted to add something I know about this subject...
They just finished a worldwide study on the FibroScan. I know this because my hepatologist and the hepatologist who performed the scan on me were the leading doctors of the project here in Denmark. All the results were sent to somewhere in the US in the beginning of July 2009.
I could imagine that after the outcome of this study, they might apply to the FDA.
'the FibroScan machine is from a french company called Ehcosens. I don't think they will ever get FDA approval. After my conversation with one of their representives back in 2007 they said if they didn't have FDA by end of the year they would stop pursuing the USA market.'
Just wanted to add something I know about this subject...
They just finished a worldwide study on the FibroScan. I know this because my hepatologist and the hepatologist who performed the scan on me were the leading doctors of the project here in Denmark. All the results were sent to somewhere in the US in the beginning of July 2009.
I could imagine that after the outcome of this study, they might apply to the FDA.
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