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BSE Test

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Novel test for mad cow disease fuels patent dispute

Local firm says inventor signed off on rights



Duncan Thorne, The Edmonton Journal

Published: Friday, July 21, 2006

Canada



EDMONTON - An Edmonton company is confident it has a cheap, ground-breaking test for mad cow disease.



But the test's British inventor -- who claims to have first made the link between BSE and the disease's human form -- insists he still holds the rights.



Edmonton's BSE Prion Solutions Inc. is just as firm that inventor Harash Narang, from Newcastle, England, signed away those rights three years ago.



"We've talked with patent attorneys in London and also in Newcastle," Ron Arnold of BSE Prion said. "Everyone agrees that the documents and the transfer of ownership of the patents was done judiciously and was extremely well put together by the solicitors."



Narang, speaking from Newcastle, acknowledged signing papers, but said it was not clear what he was signing. He said he's the one who continues to pay the patent renewal fees.



Despite their differences, Narang and BSE Prion agree the test holds amazing potential to quickly and inexpensively test live cattle for bovine spongiform encephalopathy -- better known as mad cow disease.



The only approved tests so far for mad cow and its human equivalent depend on removing brain samples after death. A test on live animals would open the way to guaranteeing disease-free herds.



Narang, a former British government scientist who went public about human risks from BSE in 1990, started developing tests for detecting the disease in the late 1980s while at a public health laboratory.



He had been studying cases of a fatal but rare human brain illness, Creutzfeldt-Jakob disease or CJD, when he started noticing some cases were different.



He has said he was well on the way to establishing a link between BSE and the unusual CJD cases when he was ordered to stop his research. He has also claimed officials rejected his calls for increased testing for BSE and the new form of CJD, now known as variant CJD.



He developed three diagnostic tests, including an early version of the urine test that BSE Prion Solutions intends to bring to market.



A wide-ranging 1998 inquiry into Britain's response to the mad cow crisis found problems with Narang's claims. It cited evidence that fellow scientists could not get his test to work.



Even so, Narang continued development of the urine test. A British company, Biotec Global, sponsored much of his work. He is no longer part of the research, but work on it continues, at the United States National Prion Disease Pathology Surveillance Center at Case Western Reserve University in Cleveland, Ohio.



Edmonton's Arnold, a partner in Biotec, said Harang gave Biotec the patent rights in 2003 and it in turn gave Edmonton's BSE Prion the licence for the Americas and Europe.



Biotec has sunk more than $2 million into the research but BSE Prion has not had to pay a licence fee, Arnold said. That's because the project is humanitarian, with plans to hand over any earnings for research purposes, in the form of grants and scholarships.



Narang, who holds shares in Biotec Global despite the ownership dispute, also said he also wants any profits to go into further research. Meanwhile, he added, he's owed back pay and expenses for work he did over the past five years -- a claim Arnold rejects.



The key issue is whether the test is effective.



"We have a test that not only works, but works each and every time," Arnold said. All it needs is formal validation, which may take up to two years, and the acceptance of regulators.



Narang and Case Western researchers reported in 2005 that the urine test could reliably detect a harmless form of the prion protein that is blamed for BSE and variant CJD. It could also detect the bad form -- if the prion was first added directly to the urine.



They said their findings "may lay the foundation for a future technique," if in fact the bad prion can turn up naturally in urine.



"It needs a lot of work still," Ayuna Dagdanova, one of the test's researchers at the U.S. prion surveillance centre, said from Cleveland.



Without solid data it's not possible to say if they are close to detecting BSE in urine, she said.



"No one actually knows.



"But preliminary experiments show the possibility."





Source: The Edmonton Journal

canada.com
 

Kathy

Well-known member
As scientists get closer to the supposed link between BSE and vCJD, they will unEarth the truth - that the human disease is not related to an infectious protein, but to contamination and/or imbalance in the brain by metals such as manganese, silver, barium, lead, uranium, strontium, cesium, etc. etc.

I see that the test involves "seeding" of the prions in the urine. This does not mean that the disease has taken hold in the animal. It only means that damaged proteins are being appropriately expelled by the immune system. So if you diagnose all these healthy animals with a TSE, you will seal their fate in death, and their genetics and resistance will die with them. God help us all.
 

bse-tester

Well-known member
Kathy wrote:

I see that the test involves "seeding" of the prions in the urine. This does not mean that the disease has taken hold in the animal. It only means that damaged proteins are being appropriately expelled by the immune system. So if you diagnose all these healthy animals with a TSE, you will seal their fate in death, and their genetics and resistance will die with them. God help us all.


Two things;

One: The excretion of PrPsc has absolutely nothing to do with the immune system. It has everything to do with PrPsc being carried in the blood stream and then filtered by the kidney's and then passed with the urine.

Two: The actual test itself does NOT involve seeding the urine with prions!

You should read the article again and not put your own interpretation into the mix. During the "proving" of the entire concept of the test itself at Case Western Reserve University, it was necessary to add PrPsc to the urine sample (yes, an homogenate of Scrapie infected Hamster brain and a urine sample) in order to see if the test procedure would actually detect PrPsc and to allow us to come up with the correct antibody to make the test work. That is the only time that "seeding" as you call it, ever occurred.

Also, your version of the truth regarding metal contamination may well have some merit as copper does have either by dosage or by its absense, have an affect on the prion and how it interacts with the neuro-network in the brain. This has been proven. Personally, it is not my goal to find out that part of the "truth." My goal is to detect the presence of PrPsc in living animals and humans - period!! Nothing more, nothing less. Having said that, I am interested in the potential for metal-contaminant causes and how it affects the function of the brain also. But my real goal in life is to detect the PrPsc and I pray to God I never do find it - that is the irony of this research!!!

One last comment Kathy - you state that although there may be PrPsc being excreted in the urine, that
"...This does not mean that the disease has taken hold of the animal. It only means that damaged proteins are being appropriately expelled by the immune system."

You are profoundly wrong in this statement. When there are sufficient numbers of the PrPsc in the system that they are manifested in the urine, it is conclusive evidence of fairly serious contamination of the animal and the animals may well be displaying clinical symptoms of infection. Having said that, if the test is sensitive enough to detect PrPsc in minute levels of urine, as our test certainly is, then they will certainly show up in the urine being excreted during the primary and non-clinical symptomatic stage of the infection.

One cannot make the assumption that, and I quote you again;

It only means that damaged proteins are being appropriately expelled by the immune system.

One might ask you to define what you mean by "damaged proteins," if our test identfies them as PrPsc??

As for the last two lines of your comment, you refer to " ...diagnosing healthy animals with a TSE and sealing their fate in death!"

I guess that if we find PrPsc in any animal, that animal is removed and disposed of immediately - by order of the appropriate authorities of course - and yes, it will die, be incinerated and its ashes subjected to further treatment to eradicate the PrPsc!!

The impression I draw from your comments is that you seem to think that we are seeding urine taken from all animals being tested, with PrPsc - not so!! Only the ones that we did in a controlled lab experiment to ensure that our test would indeed detect the presence of PRPsc. I hope that clears that up for you.
 

bse-tester

Well-known member
Murgen wrote:

Have you used "true" bovine BSE infected material to valuate the test?


PrPsc is PrPsc - wherever you find it.

When we conduct our validation, we shall be receiving some "True BSE Urine" samples from the UK VLA labs in Weybridge, Surrey. That is where the British Government keep all BSE and Scrapie urine samples in their minus 80 Degree vaults. They have agreed to send us some for our validation. As to how much we get, well that remains to be seen. We will only need about a pint or two to conduct our validation but we hoping to get more when the time comes.
 

TimH

Well-known member
:D :D :D :D :D :D :D :D :D :D :D :D :D

If everyone involved intends to "give all the profits away" why , in heavens name, would it matter who actually owns the rights to the thing????

:D :D :D :D :D :D :D :D :D :D

How stupid do you think us rural folk really are , Ronnie Boy?? :D :D :D :D :D :D :D :D :D :D :D :D :D :D :D
 

bse-tester

Well-known member
Actually Tim, I think that rural folk are extremely smart and honorable people, but, having said that, I am not sure about you!!! You obviously know little about what constitutes written agreements and what agreements and covenants mean to adults, so when you grow up Timmy boy, I would be happy to show you. Until then, be a good little boy and go play with your bubble wrap. :lol: :lol: :lol: :lol:
 

Kathy

Well-known member
Bse tester,

I certainly do not mean to offend or misrepresent you. If PrPsc is present in the urine then why it is there, is very important. Perhaps what I call the immune system, a medically trained profession would not.

When a protein is manufactured incorrectly by a mutation in the DNA, which is the map/design/protocol for the manufacturing steps, the cell must rid itself of this abherrant protein. It can be endocytosed by the lysosomes and the digestive enzymes within, break it apart. (please correct me if I am wrong, I want to learn)

The lysosome's enzymes will digest these malformed proteins. In the case of protease-resistant prions, the enzyme may only break apart some of this protein, if any.

If the lysosome is unable to digest these malformed proteins, eventually the lysosome will fill with them and explode, releaseing them and the rest of its contents into the living cell. If enough lysosomes within the cell burst and release their contents, including acidic enzymes, the cell will eventually die.

When the cell dies it causes autophagy mechanisms to kick in. Macrophages come to transport the debris out of the system. They carry the garbage to the blood stream via the lymphatic system (yes/no?) perhaps it is a more directly blood related. (I am still learning).

The garbage trucks of the body take the malformed proteins, etc. to the liver and or the kidneys. The garbage is then expelled via our urine or feces; maybe even our sputum.

If an animal is found to have PrPsc in their urine, then their body is still functioning and able to carry the garbage out (eg. out of the brain, where the damage occurred.)

Since I am more prone to believe that the PrPsc is caused by a screw-up in the initial manufacturing process, and not a post-translational change, the buildup of Prpsc in the brain may not be the result of PrPsc travelling via the blood stream to the brain, crossing the blood brain barrier. It is very plausible the causative agent(s) are transported via metallo-protein transporters like MTF, into the brain, for the manufacturing process.

Too much manganese, for example, could upset the delicate balance; providing the DNA manufacturing process with no options but to put the inappropriate metal into a copper local. Then this newly manufactured protein sequence renders the protein useless (garbage), eventually it builds up (once the lysosomes and other garbage or immune mechanisms give up their fight and stop doing their job).

If in your future work, you discover PrPsc in urine samples, I hope that the mechanisms which got them there are closely examined. It is my hope, opinion, that while our body functions properly it will continue to fight and expell the metals and malformed proteins they attach to.

When our repair mechanisms are exacerbated and stop functioning, the disease wins.

I hope this smooths over my statements. They are not designed to harm, but to debate different hypotheses.

A website I found from 2001, debates some of these very issues we have been discussing here on Ranchers, with regards to the Dr. Venter's published paper. Wherein he outlines why he doesn't believe that "infectious BSE prions" are causing vCJD.

Link: http://bmj.bmjjournals.com/cgi/eletters/323/7317/858
 

bse-tester

Well-known member
Kathy, I am not offended at all. I look forward to you comments.

Kathy wrote:

The lysosome's enzymes will digest these malformed proteins. In the case of protease-resistant prions, the enzyme may only break apart some of this protein, if any.

If the lysosome is unable to digest these malformed proteins, eventually the lysosome will fill with them and explode, releaseing them and the rest of its contents into the living cell. If enough lysosomes within the cell burst and release their contents, including acidic enzymes, the cell will eventually die.

This is only if the protein is absorbed into the lysosme. PrPsc has a tendency to be virtually invisible to the predators within the body. This is what makes this incidious little critter so darn interesting. It literally moves through the entire animal or human undeted by the very systems desgned to combat contaminant bodies.

Your analogy/description is really good and the end result of the cell death is the vacuoles that are found in the brain. The classic "Swiss Cheese effect." The areas of dead brain tissue is the result of the cell dying and the replication of the PrPsc within it.

Kathy wrote:

Since I am more prone to believe that the PrPsc is caused by a screw-up in the initial manufacturing process, and not a post-translational change, the buildup of Prpsc in the brain may not be the result of PrPsc travelling via the blood stream to the brain, crossing the blood brain barrier. It is very plausible the causative agent(s) are transported via metallo-protein transporters like MTF, into the brain, for the manufacturing process.

Too much manganese, for example, could upset the delicate balance; providing the DNA manufacturing process with no options but to put the inappropriate metal into a copper local. Then this newly manufactured protein sequence renders the protein useless (garbage), eventually it builds up (once the lysosomes and other garbage or immune mechanisms give up their fight and stop doing their job).

There is evidence to support the hypothesis that the normal PrP present in the brain - the PrP that provides a link, just like a fuse in an electrical circuit, when subjected to metal depletion or an over abundance of metals, reacts in such a way that the neurons that travel through the protein wherein they are allowed to pass to their target - a brain function that tells the host to move their little finger perhaps - are actually blocked by a protein that is not as effectively functional due to the metal depletion or metal overload. One school of thought is that this difference in the metal levels, copper in particular, is responsible for the misfolded isoform and subsequent change to the physical structure of the protein into PrPsc from PrP. The slightest drop or increase in metal content can have a profound affect on the conductivity of the neuron pathway. When the trigger is fired and the neuron is on its way to deliver its message, sotospeak, if the pathway is corrupted, then the signals are also corrupted, especially in the case of slight metal changes. In the case of high metal changes in the system, the pathways are completely cooked due to the malformation of the prion and therefore we see the clinical sysmptoms such as ataxia - shaking - and memory loss. Afterall, if the brain is not get the right or no signal at all, then it slowly ceases to function.

Keep at it Kathy.
 

TimH

Well-known member
bse-tester said:
Actually Tim, I think that rural folk are extremely smart and honorable people, but, having said that, I am not sure about you!!! You obviously know little about what constitutes written agreements and what agreements and covenants mean to adults, so when you grow up Timmy boy, I would be happy to show you. Until then, be a good little boy and go play with your bubble wrap. :lol: :lol: :lol: :lol:

Tell me Ron, since I am obviously so ignorant, what is the main reason that inventors and owners of intellectual property go to the trouble of obtaining patents and or assigning rights to their inventions, etc.??
I was always under the impression that it was mainly to prevent others from copying and profiting from their work. Is this not correct??
Oh, please do enlighten me from up on High!!!!!! :roll:
 

TimH

Well-known member
reader (the Second) said:
TimH said:
bse-tester said:
Actually Tim, I think that rural folk are extremely smart and honorable people, but, having said that, I am not sure about you!!! You obviously know little about what constitutes written agreements and what agreements and covenants mean to adults, so when you grow up Timmy boy, I would be happy to show you. Until then, be a good little boy and go play with your bubble wrap. :lol: :lol: :lol: :lol:

Tell me Ron, since I am obviously so ignorant, what is the main reason that inventors and owners of intellectual property go to the trouble of obtaining patents and or assigning rights to their inventions, etc.??
I was always under the impression that it was mainly to prevent others from copying and profiting from their work. Is this not correct??
Oh, please do enlighten me from up on High!!!!!! :roll:

Tim - I have a patent and know a bit about patents from managing SW products and talking with patent lawyers, as well as from having friends with patents in technology.

Patents PROTECT. When you invent something, you patent it, not necessarily because you are going to make a huge killing with your invention but because if you do not patent it, someone else -- perhaps several years later -- will patent it and then sue you for patent infringement and force you to stop using your invention. I believe you imply that people patent only for personal gain, but that is not true. They patent because otherwise they are in danger of not being able to use their own invention and furthermore to have to pay money to someone else for damages.

I wasn't implying anything R2. I was humbly asking a question of my intellectual "superior". :roll:
I'll give you an 8 out of 10 on the spin attempt, though. :roll: :roll:
 

Tam

Well-known member
"We've talked with patent attorneys in London and also in Newcastle," Ron Arnold of BSE Prion said. "Everyone agrees that the documents and the transfer of ownership of the patents was done judiciously and was extremely well put together by the solicitors."



Narang, speaking from Newcastle, acknowledged signing papers, but said it was not clear what he was signing. He said he's the one who continues to pay the patent renewal fees.

These two statements lead me to ask, Ron if Everyone agreed the transfer of ownership of the patent was done judiciously, then why is Narang still paying the patent renewal fees? why aren't you paying for them? And shouldn't all the rights stay with the person that is actually paying the renewal fees which in this case is Narang? :?

And doesn't this article say that they are not sure the test actually works because nobody knows if the bad prion can turn up naturally in urine, the only way this test worked was when the bad prions were ADDED DIRECTLY to the urine?
Narang and Case Western researchers reported in 2005 that the urine test could reliably detect a harmless form of the prion protein that is blamed for BSE and variant CJD. It could also detect the bad form -- if the prion was first added directly to the urine.

They said their findings "may lay the foundation for a future technique," if in fact the bad prion can turn up naturally in urine.

"It needs a lot of work still," Ayuna Dagdanova, one of the test's researchers at the U.S. prion surveillance centre, said from Cleveland.

Without solid data it's not possible to say if they are close to detecting BSE in urine, she said.

"No one actually knows
.
I thought this was a done deal and countries were using it, and now we read a lot of work still needs to be done to even find out if the Prions can naturally occur in the urine. :???:
 

bse-tester

Well-known member
Tam, you are reading the interpretation made by a newspaper reporter. As for Narang, he has a history of making statements that are somewhat misleading. The facts are plain and although you are not privy to them as I am, you are free to make whatever assumptions you wish to make, but I am here to tell you that the newspaper article was just that, an interpretation made by someone who works for a newspaper. Do you actually believe all that you read in the newspapers??? We believe only the facts!!!

Anyone can make the payments but that is not a condition that automatically allows them to have ownership of a patent. As for the patents he is paying on, the ownership is absolutely clear and the reporter did not make that clear in his article which is generally the case with newspapers these days.

Again, be careful what you print, because it is usually taken out of context as is the manner in which the article is written and the way the reporter wrote about Ayuna's comments is terrible. I actually told the reporter to expect a negative comment as it is customary for scientist to deny that a test works until it has been officially validated and until all of the data from the validation is completed, but the reprorter cut and edited her comments to suit his article and that is the end result of what you read. Again, it is misleading. And yes, the Japanese did use it!!
 

Econ101

Well-known member
Ron, if the USDA were really interested in validating tests such as yours and really making sure they worked, how long would it take? Mind you, I am talking about a full scientific trial or validation process that is credible.

Then please compare that with the amount of time you have been working on this issue.

Please make it clear who is dragging their feet.
 

bse-tester

Well-known member
Econ, tell me who you think is dragging their feet???

As for me, I have no feet to drag, I wore them off a long time ago trying to get this issue resolved. To conduct a full validation for BSE alone, will take up to 24 months. It may well take less time depending on the amount of data required to present to the European Union, in Brussels.

I am not going to debate who was dragging their tootsies, but I cn assure you it sure as hell was not me. I am and have been persuing the validation process for some time now and we are finally starting to see the end of the tunnel. Be assured, we will do this without the USDA and the CFIA. Whatever it takes to get it done we will do it.

So, to really answer your question Econ, I have spent the last 4 years trying to get the authorities involved even if it were to have them show some support, and not necessarily financial support, just plain old "OK, go ahead, we will support your idea and at the end of the process, if all works out, we promise to take a second look." But noooooo, not a darn thing, nothing, nadda, zip!! Once we begin the validation process at Case Western Reserve University in Cleveland, Ohio, the entire process will take no more that 2 years!!

Go figure, if the USDA had come aboard, so to speak, it would have been completed by now!!!!!!!!!!! :shock: :shock: :shock: So now who do you think not only dragged their feet, but hid them so that they could not even use them!!!
 

Econ101

Well-known member
That was my point, Ron. The USDA could have had your test up and running, validated and everything. They just don't want to.

The USDA isn't interested in "sound science" unless it fits their agenda.

Thanks Ron for making it completely apparent that the USDA is not interested in anything but what their politicians on the take want them to be interested in.

We have a corrupt/incompetent government right now and not enough leaders working on correcting the problems. Everyone's health is at risk with these guys at the helm of responsiblity and they are wasting our tax money.
 

Jason

Well-known member
No gov't agency should use an unvalidated test.

If BSE tester had a proven test maybe USDA or CFIA would use it. It isn't the gov't job to help independant business get a leg up on scientific research.

The OIE would be the body that would state weather the test is valid or not.

Try barking up that tree.
 

Econ101

Well-known member
Jason said:
No gov't agency should use an unvalidated test.

If BSE tester had a proven test maybe USDA or CFIA would use it. It isn't the gov't job to help independant business get a leg up on scientific research.

The OIE would be the body that would state weather the test is valid or not.

Try barking up that tree.

They could have validated or invalidated the test by now Jason.

My grandfather always said, " you have to put your bait in the water if you want to catch a fish". Our govt. regulatory agencies aren't interested in catching fish, they are interested in messing everyone else up.

Oh, I forgot, you don't understand analogies.
 
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