Faulty Antibodies Continue to Enter US and European Markets, Warns Top Clinical Chemistry Researcher# Biology - 生物学
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October 11, 2013
Faulty Antibodies Continue to Enter US and European Markets, Warns Top
Clinical Chemistry Researcher
By Adam Bonislawski
One year after alerting the proteomics community to a Chinese life sciences
company that he said had infiltrated the US and European markets with faulty
antibodies, researcher Nader Rifai told ProteoMonitor this week that the
rogue firm is still at it.
Rifai, director of clinical chemistry at Children's Hospital Boston, first
warned of the faulty antibodies in an editorial he co-authored in the
October 2012 issue of Clinical Chemistry – of which he is editor-in-chief
– along with Greg Miller, president of the American Association for
Clinical Chemistry, and Ian Watson, president of the European Federation of
Clinical Chemistry (PM 11/9/2012).
At the time, Rifai declined to go on the record with the identity of the
antibody supplier, saying that it would be inappropriate in his role as a
journal editor. This month, however, Clinical Chemistry published a study
led by University of Toronto researcher Eleftherios Diamandis that
identified the company in question as USCN Life Sciences, and, given this
publication and the firm's continued sale of faulty reagents, Rifai said
that he had decided to go public with the name.
Based in Wuhan, China, USCN produces antibodies, proteins, and immunoassay
kits. According to Rifai, the company also operates under the names EIAab
and EIAab Wuhan. Rifai added that he has contacted the US Federal Trade
Commission about USCN, and that the commission has launched an investigation
into the firm. Due to the US federal government shutdown, FTC
representatives were not available to speak about the case.
As Rifai told ProteoMonitor last year, there are several things about USCN's
products and practices that should tip off researchers to potential
problems – most notably the lack of meaningful reference material
accompanying the antibodies and the large number of antibodies, including
quite obscure proteins, offered by the firm.
He contrasted USCN to the well-established ELISA firm R&D Diagnostics, which
, despite being in business for several decades has assays to only several
hundred targets.
"Then, you have this other company that comes out of nowhere and overnight
has [antibodies to] more than 2,000 [proteins] – and not only for humans,
but for 10 or 20 different species," he said. "How can you possibly do that?"
Rifai also suggested that USCN had managed to keep its products' failings
largely under wraps by charging high prices for its antibodies – between $1
,000 and $1,500 for reagents that generally cost in the $200 to $400 range.
This practice, he said, works on two fronts. First, by making the reagents
that expensive, the company reduces the likelihood that researchers will use
their limited budgets to order the extra quantity required to do solid
validation of their purchase.
Secondly, he suggested, "psychologically, people say, 'Well, if I am paying
so much money for something, it has to work.'"
As they noted in their Clinical Chemistry paper, Diamandis and his
colleagues discovered that the USCN-sourced antibody was faulty in the
course of research into protein biomarkers for pancreatic cancer. They used
the antibody, which they initially believed was to the protein CUZD1, for
testing pancreatic cancer patient serum samples, finding that CUZD1 appeared
to be a promising marker for the disease.
When they tried to characterize the antibody as part of their validation
process, however, they found that it recognized not CUZD1 but, rather, the
established cancer marker CA125. This led the researchers to further
investigate the antibody using additional methods including mass
spectrometry, an effort that they said took two years and cost roughly $500,
000.
In addition, they wrote, the process "wasted thousands of highly valuable
patient samples and raised false expectations due to the misleading results."
The Clinical Chemistry paper is not the first publication to identify USCN
as a producer of faulty antibodies. Last September, even before Rifai
published his editorial, researchers from Harvard Medical School and the
University of Alabama published a letter to the editor in the American
Journal of Nephrology in which they expressed concern about a previously
published study using a USCN ELISA for measuring HJV protein.
In their letter, the researchers wrote that through efforts to replicate
this study, they had determined that the "USCN HJV ELISA does not detect
human or mouse HJV, but is instead recognizing some other protein(s)."
Contacted by ProteoMonitor via email, USCN General Engineer Wang Jing
suggested that Rifai's accusations were the result of "misunderstandings,"
and added that "USCN makes every effort to guarantee the quality of our
products. We have [a] strict QC process to ensure the products’ quality."
Jing did not respond by press time to the specific findings of the Diamandis
study or the AJN letter.
Perhaps more alarming than USCN's alleged practices, Rifai said, is the fact
that they have managed to obtain wide US and European distribution for
their products, including through well regarded distributors.
He cited as an example Seattle-based distributor Kamiya Biomedical, which,
he said, is a "very reputable" distributor from which his lab purchases
tests for clinical use.
Recently, Rifai said, his lab purchased a kit from Kamiya that they
suspected might be coming from USCN.
"Before we purchased the kit, we called them and said, 'Is there any chance
that this is from China?'" he said. "And they said, 'No, no, this is coming
from Japan.'"
"So, we purchased the kit and we got the kit and all the labels on the vial
say Kamiya, and all the inserted sheets says Kamiya," he said. "The only
thing is, when you look at the top of the vial, it has the insignia of USCN
Life Sciences."
Kamiya did not reply to several requests for comment.
Distributors "hide behind the excuse that, well, this is for research-use
only, so use it at your own risk," Rifai said. "And I can accept that
argument to a certain extent. But when someone is knowingly cheating, that
is different."
He noted that while the FTC investigation would not be able to shut down
USCN – and that even if it did, the company would likely just pop up again
under a different name – he hoped that the commission might make US-based
distributors liable for the products they sell.
This step "might not be reasonable" either, however, Rifai acknowledged,
noting that, ultimately, the best solution to the problem is for individual
investigators to do appropriate due diligence on the reagents they use.
He added that while Diamandis' investigation into the faulty CUZD1 antibody
cost around $500,000, researchers didn't need to take such extensive steps
to protect themselves.
"Honestly, all you need to do is buy two kits and you can evaluate them and
tell if the assay works or not," he said. "I wish fraudulent companies did
not exist, but if scientists do what they are supposed to do, they can save
themselves a lot of heartache."
Adam Bonislawski is the editor of GenomeWeb's ProteoMonitor.
He covers proteomics and life science mass spectrometry. E-mail Adam
Bonislawski and follow his GenomeWeb Twitter account at @ProteoMonitor.
Related Stories
Top Clinical Chemistry Researcher Warns of Faulty Antibodies Infiltrating US
, European Markets
November 9, 2012 / ProteoMonitor
Thermo Fisher Extends Collaborations to Validate Protein Biomarkers, Build
SRM-based Assays
March 26, 2010 / ProteoMonitor
C2N Accelerating Development of Alzheimer's Early Detection Test, Phase III
Clinical Trial Markers
October 11, 2013 / ProteoMonitor
Activiomics Looking to Move into Clinical Biomarker Research, Raise $13M in
Funding
October 11, 2013 / ProteoMonitor
New Products: Agilent and MRM Proteomics
October 11, 2013 / ProteoMonitor
October 11, 2013
Faulty Antibodies Continue to Enter US and European Markets, Warns Top
Clinical Chemistry Researcher
By Adam Bonislawski
One year after alerting the proteomics community to a Chinese life sciences
company that he said had infiltrated the US and European markets with faulty
antibodies, researcher Nader Rifai told ProteoMonitor this week that the
rogue firm is still at it.
Rifai, director of clinical chemistry at Children's Hospital Boston, first
warned of the faulty antibodies in an editorial he co-authored in the
October 2012 issue of Clinical Chemistry – of which he is editor-in-chief
– along with Greg Miller, president of the American Association for
Clinical Chemistry, and Ian Watson, president of the European Federation of
Clinical Chemistry (PM 11/9/2012).
At the time, Rifai declined to go on the record with the identity of the
antibody supplier, saying that it would be inappropriate in his role as a
journal editor. This month, however, Clinical Chemistry published a study
led by University of Toronto researcher Eleftherios Diamandis that
identified the company in question as USCN Life Sciences, and, given this
publication and the firm's continued sale of faulty reagents, Rifai said
that he had decided to go public with the name.
Based in Wuhan, China, USCN produces antibodies, proteins, and immunoassay
kits. According to Rifai, the company also operates under the names EIAab
and EIAab Wuhan. Rifai added that he has contacted the US Federal Trade
Commission about USCN, and that the commission has launched an investigation
into the firm. Due to the US federal government shutdown, FTC
representatives were not available to speak about the case.
As Rifai told ProteoMonitor last year, there are several things about USCN's
products and practices that should tip off researchers to potential
problems – most notably the lack of meaningful reference material
accompanying the antibodies and the large number of antibodies, including
quite obscure proteins, offered by the firm.
He contrasted USCN to the well-established ELISA firm R&D Diagnostics, which
, despite being in business for several decades has assays to only several
hundred targets.
"Then, you have this other company that comes out of nowhere and overnight
has [antibodies to] more than 2,000 [proteins] – and not only for humans,
but for 10 or 20 different species," he said. "How can you possibly do that?"
Rifai also suggested that USCN had managed to keep its products' failings
largely under wraps by charging high prices for its antibodies – between $1
,000 and $1,500 for reagents that generally cost in the $200 to $400 range.
This practice, he said, works on two fronts. First, by making the reagents
that expensive, the company reduces the likelihood that researchers will use
their limited budgets to order the extra quantity required to do solid
validation of their purchase.
Secondly, he suggested, "psychologically, people say, 'Well, if I am paying
so much money for something, it has to work.'"
As they noted in their Clinical Chemistry paper, Diamandis and his
colleagues discovered that the USCN-sourced antibody was faulty in the
course of research into protein biomarkers for pancreatic cancer. They used
the antibody, which they initially believed was to the protein CUZD1, for
testing pancreatic cancer patient serum samples, finding that CUZD1 appeared
to be a promising marker for the disease.
When they tried to characterize the antibody as part of their validation
process, however, they found that it recognized not CUZD1 but, rather, the
established cancer marker CA125. This led the researchers to further
investigate the antibody using additional methods including mass
spectrometry, an effort that they said took two years and cost roughly $500,
000.
In addition, they wrote, the process "wasted thousands of highly valuable
patient samples and raised false expectations due to the misleading results."
The Clinical Chemistry paper is not the first publication to identify USCN
as a producer of faulty antibodies. Last September, even before Rifai
published his editorial, researchers from Harvard Medical School and the
University of Alabama published a letter to the editor in the American
Journal of Nephrology in which they expressed concern about a previously
published study using a USCN ELISA for measuring HJV protein.
In their letter, the researchers wrote that through efforts to replicate
this study, they had determined that the "USCN HJV ELISA does not detect
human or mouse HJV, but is instead recognizing some other protein(s)."
Contacted by ProteoMonitor via email, USCN General Engineer Wang Jing
suggested that Rifai's accusations were the result of "misunderstandings,"
and added that "USCN makes every effort to guarantee the quality of our
products. We have [a] strict QC process to ensure the products’ quality."
Jing did not respond by press time to the specific findings of the Diamandis
study or the AJN letter.
Perhaps more alarming than USCN's alleged practices, Rifai said, is the fact
that they have managed to obtain wide US and European distribution for
their products, including through well regarded distributors.
He cited as an example Seattle-based distributor Kamiya Biomedical, which,
he said, is a "very reputable" distributor from which his lab purchases
tests for clinical use.
Recently, Rifai said, his lab purchased a kit from Kamiya that they
suspected might be coming from USCN.
"Before we purchased the kit, we called them and said, 'Is there any chance
that this is from China?'" he said. "And they said, 'No, no, this is coming
from Japan.'"
"So, we purchased the kit and we got the kit and all the labels on the vial
say Kamiya, and all the inserted sheets says Kamiya," he said. "The only
thing is, when you look at the top of the vial, it has the insignia of USCN
Life Sciences."
Kamiya did not reply to several requests for comment.
Distributors "hide behind the excuse that, well, this is for research-use
only, so use it at your own risk," Rifai said. "And I can accept that
argument to a certain extent. But when someone is knowingly cheating, that
is different."
He noted that while the FTC investigation would not be able to shut down
USCN – and that even if it did, the company would likely just pop up again
under a different name – he hoped that the commission might make US-based
distributors liable for the products they sell.
This step "might not be reasonable" either, however, Rifai acknowledged,
noting that, ultimately, the best solution to the problem is for individual
investigators to do appropriate due diligence on the reagents they use.
He added that while Diamandis' investigation into the faulty CUZD1 antibody
cost around $500,000, researchers didn't need to take such extensive steps
to protect themselves.
"Honestly, all you need to do is buy two kits and you can evaluate them and
tell if the assay works or not," he said. "I wish fraudulent companies did
not exist, but if scientists do what they are supposed to do, they can save
themselves a lot of heartache."
Adam Bonislawski is the editor of GenomeWeb's ProteoMonitor.
He covers proteomics and life science mass spectrometry. E-mail Adam
Bonislawski and follow his GenomeWeb Twitter account at @ProteoMonitor.
Related Stories
Top Clinical Chemistry Researcher Warns of Faulty Antibodies Infiltrating US
, European Markets
November 9, 2012 / ProteoMonitor
Thermo Fisher Extends Collaborations to Validate Protein Biomarkers, Build
SRM-based Assays
March 26, 2010 / ProteoMonitor
C2N Accelerating Development of Alzheimer's Early Detection Test, Phase III
Clinical Trial Markers
October 11, 2013 / ProteoMonitor
Activiomics Looking to Move into Clinical Biomarker Research, Raise $13M in
Funding
October 11, 2013 / ProteoMonitor
New Products: Agilent and MRM Proteomics
October 11, 2013 / ProteoMonitor