Borrelia miyamotoi Testing: Is There an FDA-Approved Test?
Borrelia miyamotoi diagnosis can be challenging
Many patients rely on PCR and specialized laboratory testing
Diagnostic access remains an important public health issue
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 laboratories and severely restrict a clinician’s ability to diagnose Lyme disease, as well as other tick-borne co-infections.
One important question facing clinicians is whether there is an FDA-approved test for Borrelia miyamotoi, an emerging tick-borne relapsing fever infection transmitted by Ixodes ticks.
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]
Borrelia miyamotoi is one of several emerging tick-borne coinfections that may present with symptoms overlapping Lyme disease.
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.
Is There an FDA-Approved Test for Borrelia miyamotoi?
Researchers have had to diagnose B. miyamotoi based on blood smear, [5] 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]
Published studies have relied heavily on PCR-based methods for identifying Borrelia miyamotoi DNA in blood and cerebrospinal fluid samples.
These are all non FDA-approved tests. So, where would these patients be if the FDA insisted on only its tests being utilized?
For a broader discussion of diagnostic challenges involving Lyme disease and related infections, see our guide to Lyme test accuracy.
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 types of Lyme disease diagnostic tests.
Frequently Asked Questions
Is there an FDA-approved test for Borrelia miyamotoi?
At the time this article was written, diagnosis often relied on PCR testing, blood smear evaluation, cerebrospinal fluid analysis, and other specialized laboratory methods rather than a widely available FDA-approved diagnostic test.
How is Borrelia miyamotoi diagnosed?
Researchers have diagnosed Borrelia miyamotoi infections using blood smears, PCR testing, molecular detection of bacterial DNA, and cerebrospinal fluid testing in selected cases.
Can PCR testing identify Borrelia miyamotoi?
Yes. PCR testing has been used in published studies to detect Borrelia miyamotoi DNA in patient blood and cerebrospinal fluid samples.
Is Borrelia miyamotoi related to Lyme disease?
Borrelia miyamotoi is genetically distinct from Borrelia burgdorferi, the bacterium that causes Lyme disease, but both may be transmitted by Ixodes ticks and can present with overlapping symptoms.
What symptoms can Borrelia miyamotoi cause?
Symptoms may include fever, headache, fatigue, muscle aches, and neurologic complaints that can overlap with Lyme disease and other tick-borne infections.
Clinical Takeaway
Borrelia miyamotoi highlights the challenges clinicians face when diagnosing emerging tick-borne infections. As new pathogens continue to be identified, laboratory-developed tests may play an important role in expanding diagnostic options while researchers pursue broader validation and regulatory review.
Restricting access to innovative diagnostic testing could make it more difficult to recognize emerging tick-borne diseases such as Borrelia miyamotoi.
Related Articles
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Persistent Lyme disease mechanisms
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References
- FDA to regulate tests for Lyme disease, other illnesses. Boston Globe article. Last accessed 10/26/14.
- Krause PJ, Narasimhan S, Wormser GP et al. Human Borrelia miyamotoi infection in the United States. N Engl J Med. 2013;368(3):291-293.
- Chowdri HR, Gugliotta JL, Berardi VP et al. Borrelia miyamotoi infection presenting as human granulocytic anaplasmosis: a case report. Ann Intern Med. 2013;159(1):21-27.
- 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. 2014;9(10):e110853.
- Dworkin MS, Schwan TG, Anderson DE Jr., Borchardt SM. Tick-borne relapsing fever. Infect Dis Clin North Am. 2008;22(3):449-468.
- Gugliotta JL, Goethert HK, Berardi VP, Telford SR 3rd. Meningoencephalitis from Borrelia miyamotoi in an immunocompromised patient. N Engl J Med. 2013;368(3):240-245.
- Hovius JW, de Wever B, Sohne M et al. A case of meningoencephalitis by the relapsing fever spirochaete Borrelia miyamotoi in Europe. Lancet. 2013;382(9892):658.
Dr. Daniel Cameron, MD, MPH
Lyme disease clinician with over 30 years of experience and past president of ILADS.
Symptoms • Testing • Coinfections • Recovery • Pediatric • Prevention
