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Cooperative Diagnostics Pulls XMRV Molecular Test from Clinical Market
April 05, 2010
By Kirell Lakhman
Cooperative Diagnostics has voluntarily pulled its XMRV molecular assay from the clinical market due to the "controversial" claim linking the virus with chronic fatigue syndrome.
The company launched the assay last October as a way to "assist physicians in the diagnosis of chronic fatigue syndrome and other disorders potentially caused by the virus." The test, which uses real-time PCR to detect the xenotropic murine leukemia-related virus, was also made available directly to patients.
Cooperative Diagnostics' decision became noteworthy today after US regulators said the nation's blood supply could be at "potential risk" of being infected with XMRV.
In a statement announcing the release of its XMRV assay last fall, Cooperative Diagnostics said the virus was "identified in 95 percent" of all patients with CFS, and in "large numbers" of patients with fibromyalgia and atypical multiple sclerosis.
"When we learned that XMRV might have such a high association with chronic fatigue syndrome, we immediately became interested in developing a test," CEO Brent Satterfield said in the statement. "Now, [anyone] who has suffered from the condition can take testing for XMRV into their own hands."
That was then. Today I noticed that Cooperative Diagnostics' web site says the company has stopped offering the test clinically, which cost $399 and was processed at Clinical Reference Laboratory. The test will be available for research use only.
The link between XMRV and CFS "has been highly publicized by the media," causing "many people in the CFS community [to take] this information to mean that XMRV is most likely the underlying cause of the disease," Cooperative Diagnostics said in a sidebar of its XMRV FAQ page.
It wasn't immediately clear when the notice appeared on the site, which also says "XMRV may or may not be present in the general CFS community, let alone be the cause."
People with CFS, therefore, "may be better served by waiting for further studies connecting XMRV to CFS prior to investing in a diagnostic," the company says.
As for the nation's blood supply, the Wall Street Journal today reports that "[e]fforts are under way to find effective tests for the virus and determine its prevalence, led by a working group funded by the National Institutes of Health and including federal agencies such as the FDA and the Centers for Disease Control and Prevention. Blood banks, academic institutions and at least one advocacy group are also involved."
There is no FDA-licensed lab test for XMRV; "officials say they are still setting standards for diagnosing it," according to the Journal.
April 05, 2010
By Kirell Lakhman
Cooperative Diagnostics has voluntarily pulled its XMRV molecular assay from the clinical market due to the "controversial" claim linking the virus with chronic fatigue syndrome.
The company launched the assay last October as a way to "assist physicians in the diagnosis of chronic fatigue syndrome and other disorders potentially caused by the virus." The test, which uses real-time PCR to detect the xenotropic murine leukemia-related virus, was also made available directly to patients.
Cooperative Diagnostics' decision became noteworthy today after US regulators said the nation's blood supply could be at "potential risk" of being infected with XMRV.
In a statement announcing the release of its XMRV assay last fall, Cooperative Diagnostics said the virus was "identified in 95 percent" of all patients with CFS, and in "large numbers" of patients with fibromyalgia and atypical multiple sclerosis.
"When we learned that XMRV might have such a high association with chronic fatigue syndrome, we immediately became interested in developing a test," CEO Brent Satterfield said in the statement. "Now, [anyone] who has suffered from the condition can take testing for XMRV into their own hands."
That was then. Today I noticed that Cooperative Diagnostics' web site says the company has stopped offering the test clinically, which cost $399 and was processed at Clinical Reference Laboratory. The test will be available for research use only.
The link between XMRV and CFS "has been highly publicized by the media," causing "many people in the CFS community [to take] this information to mean that XMRV is most likely the underlying cause of the disease," Cooperative Diagnostics said in a sidebar of its XMRV FAQ page.
It wasn't immediately clear when the notice appeared on the site, which also says "XMRV may or may not be present in the general CFS community, let alone be the cause."
People with CFS, therefore, "may be better served by waiting for further studies connecting XMRV to CFS prior to investing in a diagnostic," the company says.
As for the nation's blood supply, the Wall Street Journal today reports that "[e]fforts are under way to find effective tests for the virus and determine its prevalence, led by a working group funded by the National Institutes of Health and including federal agencies such as the FDA and the Centers for Disease Control and Prevention. Blood banks, academic institutions and at least one advocacy group are also involved."
There is no FDA-licensed lab test for XMRV; "officials say they are still setting standards for diagnosing it," according to the Journal.
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