Where is the FDA test for relapsing fever spirochete, Borrelia miyamotoi?
The US Food and Drug Administration (FDA) is pushing to regulate (or eliminate altogether) laboratory developed tests (LDT).  Diagnostic tests for Lyme disease will be targeted, initially, as the FDA begins to phase in its oversight.
If the FDA gets its way, physicians would only have access to diagnostic tests for tick borne diseases that are FDA approved. This would eliminate “specialty labs,” and severely restrict a clinicians ability to diagnose Lyme disease, as well as other tick-borne co-infections. This is a dangerous move in a period when we’re seeing an emergence of multiple tick-borne pathogens.
For example, Borrelia miyamotoi is a relatively new bacterium that can cause relapsing fever and symptoms similar to Lyme disease. It was only recently identified in 2011 in Russia and has since been found in the Netherlands, Japan, and northeastern United States and California. [2-4]
Where is the FDA-approved test for B. miyamotoi?
The tick population is exploding and expanding to new regions; complex vector borne organisms are emerging, posing a threat to public health and the federal funds for research are stretched thin. The FDA’s move to eliminate lab developed tests for tick borne diseases would only stifle innovation, and discourage researchers and pathologists from searching for solutions. In the end, the growing number of patients infected with Lyme disease will pay the price. As will all those, still undiagnosed.
Researchers have had to diagnose B. miyamotoi based onblood smear,  direct detection of spirochetes in cerebrospinal fluid and follow-up polymerase chain reaction (PCR) [6,7] and molecular detection of B. miyamotoi DNA in acute whole blood from patients.[2,7] These are all non FDA-approved tests. So, where would these patients be if the FDA insisted on only its tests being utilized?
Lyme disease is an epidemic. Now is not the time to limit the availability of lab tests that have undergone a rigorous evaluation process and adhere to regulations by the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA).
“It is premature to require further regulatory oversight of the tests we need for emerging tick-borne illnesses,” says Dr. Daniel Cameron, an Internist and Epidemiologist.
This is the first in a series of blog articles to come focusing on the FDA’s attempts to regulate lab developed tests.
For a summary on types of tests, visit https://danielcameronmd.com/lyme-diagnosis-tests/
- FDA to regulate tests for Lyme disease, other illnesses, Available from https://www.bostonglobe.com/lifestyle/health-wellness/2014/07/31/fda-plans-regulate-diagnostic-tests-now-exempt-from-oversight/7u7yqVsHaBjOTFW4y0RJwL/story.html Last accessed 10/26/14. (Ed.^(Eds)
- Krause PJ, Narasimhan S, Wormser GP et al. Human Borrelia miyamotoi infection in the United States. N Engl J Med, 368(3), 291-293 (2013).
- Chowdri HR, Gugliotta JL, Berardi VP et al. Borrelia miyamotoi infection presenting as human granulocytic anaplasmosis: a case report. Ann Intern Med, 159(1), 21-27 (2013).
- Padgett K, Bonilla D, Kjemtrup A et al. Large Scale Spatial Risk and Comparative Prevalence of Borrelia miyamotoi and Borrelia burgdorferi Sensu Lato in Ixodes pacificus. PLoS One, 9(10), e110853 (2014).
- Dworkin MS, Schwan TG, Anderson DE, Jr., Borchardt SM. Tick-borne relapsing fever. Infect Dis Clin North Am, 22(3), 449-468, viii (2008).
- Gugliotta JL, Goethert HK, Berardi VP, Telford SR, 3rd. Meningoencephalitis from Borrelia miyamotoi in an immunocompromised patient. N Engl J Med, 368(3), 240-245 (2013).
- Hovius JW, de Wever B, Sohne M et al. A case of meningoencephalitis by the relapsing fever spirochaete Borrelia miyamotoi in Europe. Lancet, 382(9892), 658 (2013).
From the CT Attorney Generals report (May 1, 2008) after its lengthy investigation…. “”The IDSA’s 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests — in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies — to exclude divergent medical evidence and opinion.” Paul Auwaerter (Johns Hopkins and IDSA spokes person), now with a seat on the FDA panel, and coauthor on Hopkins 2005 study proving 75% of people are missed using his preferred FDA approved Lyme tests, may be concerned since money generated from lab tests in Maryland (and other areas) has dropped drastically. In the 1990’s approx. $2 million in revenue from FDA approved Lyme tests was generated annually in Maryland alone. Now, due to the standard Lyme tests well deserved bad reputation and competition from much better labs, patent holders pocket books are being pinched.
Is there anything those of us in the community can do? Someone we should write in protest?
You could reply to the survey at https://lymedisease.org/news/lymepolicywonk/lymepolicywonk-fda-regulation-of-lyme-tests-take-the-survey-ne.html.
please don’t just act on something without knowing the facts . The facts are that because the tier testing for Lyme and other tick Bourne illness is so unreliable it’s worthless . These diseases destroy lives., and families. I have been unable to work , and unable to participate in life. It’s a horrible existence . With no accuracy In testing, we have no way to get better . Please don’t stop the people who are doing the research and developing test to help solve this problem. It’s i humane to treat people this way. Animals are given more concern in our country by our government Heath community
The movement to eliminate roadblocks to innovative or “advanced” testing in general must be started. Government agencies should not use their power to deny disease and eliminate innovation and competition, but this is just what they do. Sadly, the lobbyist culture remains strong at all levels of government. People’s lives are at stake. I’m fighting my own fight and wish their was a way to channel that energy in a meaningful way. Where to start?
What am I going to do ??? This strain is prevalent in TN also ,where I was bitten by 2 ticks in 2001 . Test after useless test only gives reason for me to be denied treatment ,SSD claim-DENIED , have no resources ,no Doctor , little hope . I am losing the battle …….I have thought about asking to be given the Right to Die ,I live in Oregon where this is granted with dignity . Something I have very little of in my life -Dignity . Just grasping at straws that are non-existent …even if I do get a positive test ., I cannot afford treatment anyway ….If the Ebola train comes to my town , I might just get on it . 15 years of endless pain & suffering -just about over it now ………….
This action was precipitated by Senator Blumenthal’s letter to the FDA in response to the CDC’s trashing of Eva Sapi’s culture test. They claimed it failed their analysis, implying that it somehow did not meet a CDC standard that is nonexistent.
This test, available through Advanced Laboratory Services, might be a good test. However, we don’t know unless it is subjected to a validation analysis. That is precisely what Senator Blumenthal and his colleagues called for, in their letter to the FDA. They are holding the FDA to their own rules for validation of a bioanalytical method.
What we need is to get rid of the two-tier “Dearborn standard,” which most definitely does not meet the the validation standards for accuracy, specificity, etc. As a complementary campaign to the senators’ action, a group of Lyme patients have established “CDC: No More Tiers.” Our campaign urges Lyme patients to report adverse events from the fraudulent two-tier test (a medical device) to the FDA’s Medwatch system.
We hope that by flooding the FDA with our tears, the notoriously inaccurate two-tier protocol will be forced to undergo an official review and ultimately be eliminated.