Testing for XMRV

Since the Science publication linking XMRV to CFS, three commercial laboratories have offered XMRV tests. The first to market was Cooperative Diagnostics (www.codiagnostics.com), a S.C. company, with a DNA-based home test kit. The company recently discontinued its clinical testing service and is only conducting XMRV tests on a research basis.

The second company to offer XMRV tests was VIP Diagnostics (www.VIPdx.com), a Nevada company once owned by the Whittemore family and formerly known as RedLabs USA. VIP Dx is marketing a culture test for $450 using the same methods as were reported in the Science article. The website discloses that the tests have not been approved by FDA for diagnostic purposes and that medical expertise is required for test interpretation. An announcement issued on June 1, 2010 indicates that multiplex serological testing will be available by July 1 and that The Whittemore Peterson Institute will acquire VIP Diagnostics. WP Bio, a subsidiary of WPI, will offer testing for European patients through a license agreement with R.E.D. Laboratories of Belgium. No further announcements regarding the availability of a serological test have been made since June 1.

Clongen Laboratories, LLC, began offering an XMRV test on Jan. 13, 2010. Described as a CLIA-certified infectious diseases diagnostic lab, Clongen offers a real-time PCR test for $375 with a turnaround time of 3-5 days. According to information on its website, Clongen has a staff of scientists trained and licensed as clinical laboratory scientists to interpret test results in relation to clinical interventions.

CFS experts have expressed caution regarding new tests for XMRV. In his Nov. 3, 2009 Lyndonville Times newsletter, Dr. David Bell provided the following guidance, “I am reluctant to suggest to anyone that they spend big bucks for a commercial test now. We do not know if a particular test is accurate, and even if it is accurate we do not know what it means, and even if we did know what it meant we would not know what to do with it. I would be patient. Answers will start flowing soon, so stay tuned!”

Dr. Nancy Klimas, speaking at a patient meeting in Florida on Nov. 7, 2009, made the following recommendation, “Don’t rush to get the test. Why, because you’re not going to act on that test quite yet. The knowledge of being positive is not going to get you an antiviral prescription from anyone right now because we don’t know which one to give and if it’s safe or if it’s toxic. The HIV drugs are not gentle, and you guys are really tender. If you knew your status today it really wouldn’t change anything.”

Dr. Lucinda Bateman offered her opinion when speaking at an OFFER program for patients on Dec. 2, 2009, “It’s definitely anyone’s prerogative to do what they want in terms of testing… I think it will not be long before we have local access to the lab test that will have been tested, perfected and validated and covered by insurance. The second most important thing is that we don’t know what to do with the information yet. There’s no hurry. What you don’t want to do is rush and get the wrong diagnosis and get a test that is negative when it should be positive or positive when it should be negative. While I think this is a worthy lab, we don’t know how these findings apply to people in other areas. At this point, I would save your money and wait just a little longer.”

Dr. Charles Lapp recommended that patients hold off for now on getting tested, until testing methods have been standardized and validated. This statement was made during the Q&A of his May 20 webinar hosted by the CFIDS Association.

Speaking at the Oct. 29, 2009 meeting of the CFS Advisory Committee, retrovirology expert Dr. John Coffin reported that the National Cancer Institute (NCI) is working intently to develop assays using validated specimens so that “everybody is on the same page, using the same assays for this virus.”

A letter from NCI director Dr. John Niederhuber to the Association reiterates his institute’s commitment to test development. “We are taking a proactive approach to developing suitable, well-validated assays to detect XMRV infections.” NCI has repeated this committment in a Q&A issued on Nov. 18, 2009.

Certified laboratories can market tests with little regulation by federal agencies; however, diagnostic tests for conditions and diseases are subject to review and approval by the Food and Drug Administration before they can be marketed as such. Insurance companies’ reimbursement policies vary, however without FDA approval, it may be challenging to obtain coverage for the XMRV tests now on the market. Labs may offer to file with Medicare for reinbursement, but this does not mean that Medicare will cover the cost of testing for XMRV.

Additional information on XMRV
Fact Sheet from AABB on XMRV

This information was updated on July 16, 2010.