# Bio-Rad's Second Generation CWD Test Approved by USDA (STILL REFUSING TO RAPID TSE TE



## terry (Sep 13, 2002)

-------- Original Message --------
Subject: Bio-Rad's Second Generation CWD Test Approved by USDA (STILL REFUSING TO RAPID TSE TEST CATTLE)
Date: Wed, 16 Jul 2003 08:17:26 -0500
From: "Terry S. Singeltary Sr." <[email protected]>
To: BSE-L <[email protected]>


Bio-Rad's Second Generation CWD Test Approved by USDA
Tuesday July 15, 3:18 pm ET

New Test Kit Used on Automated Platform Increases Testing Capacity, 
Enabling Laboratories to Test Up to 1000 Samples Per Day

HERCULES, Calif., July 15 /PRNewswire-FirstCall/ -- Bio-Rad 
Laboratories, Inc. (Amex: BIO; BIO.B), a multinational manufacturer and 
distributor of life science research products and clinical diagnostics 
announced today that it has received approval from the United States 
Department of Agriculture (USDA) to sell its TeSeE® test kit, the 
company's second generation test kit used for the detection of Chronic 
Wasting Disease (CWD) in deer and elk. This CWD test kit is the only one 
of its kind. It runs on an automated robotics platform that speeds up 
sample preparation, enabling laboratories to provide faster results. 
Technicians using this new testing platform can process up to 1,000 
samples per day.




Validation data collected from a study led by Dr. Barbara Powers of 
Colorado State University Veterinary Diagnostic Laboratory, Fort 
Collins, showed that the test kit performed successfully when compared 
to the immunohistochemistry (IHC) test. The benefit of the new Bio-Rad 
test is that it offers the same level of sensitivity as the IHC method, 
but more samples can be tested in a shorter amount of time and with 
fewer technicians than IHC. The IHC method takes three to five days to 
obtain results, whereas the Bio-Rad test can be completed in less than 
five hours.

"We are pleased to be able to provide this new platform to laboratories 
conducting CWD testing and hope that it will assist them in their 
efforts to meet the increasing demand for rapid testing," said Norman 
Schwartz, Bio-Rad President and CEO.

This new CWD test is based on the same proven technology as Bio-Rad's 
first generation CWD test, which was approved by the USDA in October 
2002. The test uses the ELISA (enzyme-linked immunosorbent assay) method 
to detect the abnormal prion protein associated with Chronic Wasting 
Disease and is reported to be the fastest and the easiest method to 
adapt to mass screening programs. Bio-Rad's first generation CWD test 
was used to screen deer and elk samples during the 2002 hunting season.

Bio-Rad Laboratories, Inc. (www.bio-rad.com ) is 
a multinational manufacturer and distributor of life science research 
products and clinical diagnostics. It is based in Hercules, California, 
and serves more than 70,000 research and industry customers worldwide 
through a network of more than 30 wholly owned subsidiary offices.

Various statements made within this press release may constitute 
"forward-looking statements" for purposes of the Securities and Exchange 
Commission's "safe harbor" provisions under the Private Securities 
Litigation Reform Act of 1995 and Rule 3b-6 under the Securities 
Exchange Act of 1934. The forward-looking statements contained herein 
involve risks and uncertainties that could cause results to differ 
materially from the Company's expectations.


------------------------------------------------------------------------
Source: Bio-Rad Laboratories, Inc.

http://biz.yahoo.com/prnews/030715/sftu107_1.html

what is wrong with using Bio-Rad or Prionics rapid TSE
test on cattle???

why does USDA refuse to approve a rapid test for USA cattle $$$\

1 million BSE/TSE rapid test on USA cattle annually for 5 years !

USA BSE/TSE GBR to III ASAP !

TSS


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## PrtyMolusk (Aug 13, 2000)

Howdy-

That appears to be good news....but only if the State of Michigan is willing to purchase and use this new test.

Any word on whether they plan on using it?


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## terry (Sep 13, 2002)

-------- Original Message --------
Subject: Re: Bio-Rad's Second Generation CWD Test Approved by USDA (STILL REFUSING TO RAPID TSE TEST CATTLE)
Date: Sun, 20 Jul 2003 00:21:29 +0200
From: Moser Markus <[email protected]>
Reply-To: Bovine Spongiform Encephalopathy <[email protected]>
To: [email protected]


######## Bovine Spongiform Encephalopathy #########

Hi Terry

Careful, when you obtain your information from a TSE congress sponsored
by a commercial BSE-test manufacturer.

The Bio-Rad test is not the fastest test, the test of Enfer as well as
the newly EU-approved LIA from Prionics are both faster. I know that
Bio-Rad has a long history of claiming that they are more sensitive than
anybody else: In France they claimed for example that they would detect
more BSE-cases than the Prionics Western BSE-Test. However, when the
statistical data from the surveillance system became publicly available
they had to admit that there was no difference between the two test
systems.



The US is currently doing all their BSE checks with the classical
"gold-standard" method called "immunohistochemistry" which hardly, if at
all results in false positive results. The above mentioned Bio-Rad,
Enfer and the Prionics LIA tests are all so-called ELISA systems which
will, to various degrees, produce false positive results. In a country
with no BSE-cases or only single cases this would mean that you would
produce many more false than correct positive results, which is a
situation the US authorities understandably are sceptical about. An
alternative to the above immunohistochemistry procedure which is equally
suitable for both low-level or high-level BSE-countries is the
Prionics-Check Western-blotting procedure, a rapid-test which does not
produce any false posititve results. This test has been used to reveal
the true extent of BSE in Europe (see "Milestones of BSE-surveillance":
http://www.prionics.ch/prionics-e-diagnostics-western-milestones.pdf
)and has since been reliably used over 15 million times, including in
BSE-free countries like Australia and New Zealand. The recent checks in
Canada were also performed with this test.

It has to be noted, however, that a good surveillance system can also be
performed with immunohistochemistry, provided that you are willing to
test significant numbers of animals and provided that the technique is
done by educated people and in a standardized manner.

Regards

Markus Moser



-----Original Message-----
From: Terry S. Singeltary Sr. [mailto:[email protected]] 
Sent: Samstag, 19. Juli 2003 00:03
To: [email protected]
Subject: Re: Bio-Rad's Second Generation CWD Test Approved by USDA
(STILL REFUSING TO RAPID TSE TEST CATTLE)



At a TSE meeting sponsored by Bio-Rad last year I overheard that the

reagents used in the to Bio-Rad tests for CWD are the same as those used

in the BSE test in Europe. If true, the most rapid and sensitive BSE

test is approved for use in the U.S. but the government wants it limited

to CWD. Be interesting if someone started testing cows on their own ...



http://www.vegsource.com/talk/madcow/messages/788.html



MAYBE, someone could elaborate on this please ???



thanks terry



SNIP...


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## Fierkej (Dec 21, 2001)

Hi,
Michigan State University's Diagnostic Center for Population and Animal Health will be using the new Bio-Rad ELISA test for CWD this fall for our deer surveillance program. 
This link will take you to the Bio-Rad page about the test.
http://www.bio-rad.com/B2B/BioRad/p...Wasting+Disease&divName=Life+Science+Research

The test involves...
"Selective degradation of normal proteins with proteinase K allows improved isolation of the disease-associated abnormal prion. The sample is concentrated for further sensitivity. The ELISA test utilizes two specific monoclonal antibodies, ensuring increased selectivity."

Jean


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## terry (Sep 13, 2002)

hello Jean and all in Michigan,

i must applaud you for this.
whether it be Bio-RAD or Enfer
or Prionics, at least it is a step
forward. maybe i can send a
few head of cattle to you on
ice, and you can test for me
on the buff ;-) i know of a
few from TEXAS i would like
to test $ for sure...

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle
R.F. Marsh* and G.R. Hartsough

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf

Docket Management
Docket: 02N-0273 - Substances Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

Asante/Collinge et al, that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest _sporadic_ CJD;


http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [[email protected]] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

Docket No: 01-064-1
Title: Animal Disease Risk Assessment, Prevention, and Control Act
Contact Person: Mr. William Macheel, (301) 734-4420
Comments Due: October 9, 2001
Received on E-comments
24. Terry S. Singeltary Sr. 8/22/01

http://www.aphis.usda.gov/ppd/rad/LPOC/01-064-1.txt

EPA Comment Number: 550-2 Received: October 26, 1998
Subject: DOCKET # opp-00550 FEDERAL FOOD AND SAFETY PLAN!!!

http://216.239.41.104/search?q=cach...CKET+#+opp-00550+FEDERAL+FOOD+AND+SAFETY+PLAN!!!++tss&hl=en&ie=UTF-8

http://www.epa.gov/oppts/documents/550-2.pdf

British Medical Journal

http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1

Subject: DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of Material >From Deer and Elk in Animal Feed; Availability
Date: Fri, 16 May 2003 11:47:37 -0500
From: "Terry S. Singeltary Sr."
To: [email protected]


Greetings FDA,

snip...

http://www.vegsource.com/talk/madcow/messages/448.html

TSS


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