Borrelia miyamotoi FDA Test: Why the Diagnostic Gap Matters

The FDA Testing Gap for Emerging Tick-Borne Diseases

There is currently no FDA-approved test for Borrelia miyamotoi. This gap highlights a larger problem in diagnostic medicine: emerging tick-borne infections are being identified faster than regulatory pathways can support testing. :contentReference[oaicite:0]{index=0}

If testing were limited only to FDA-approved methods, clinicians would lose access to many of the tools currently used to diagnose tick-borne diseases—including Lyme disease and co-infections—leaving patients undiagnosed and untreated.

Borrelia miyamotoi is a relatively new bacterium that can cause relapsing fever and symptoms similar to Lyme disease. First identified in 2011 in Russia, it has since been detected in the Netherlands, Japan, and across the United States.

This illustrates a fundamental problem: new pathogens emerge faster than the FDA approval process can accommodate them.

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No Borrelia miyamotoi FDA Test Available

There is currently no FDA-approved test for Borrelia miyamotoi. All existing diagnostic methods are lab-developed tests (LDTs)—the very tests that could be restricted under proposed regulatory changes.

The tick population is expanding geographically, and new vector-borne pathogens continue to emerge. At the same time, research funding remains limited.

Restricting lab-developed tests in this environment risks slowing innovation and limiting clinicians’ ability to diagnose emerging infections.

This creates a dangerous gap between emerging science and real-world clinical care.

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Current Testing Methods for Borrelia miyamotoi

Clinicians currently diagnose B. miyamotoi using:

• Blood smear
• Direct detection of spirochetes in cerebrospinal fluid
• Polymerase chain reaction (PCR)
• Molecular detection of bacterial DNA in whole blood

All of these are lab-developed tests.

Without these tools, clinicians would have no reliable way to confirm diagnosis.

So where would these patients be if only FDA-approved tests were allowed?

Undiagnosed. Untreated. And often dismissed.

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How Lab-Developed Tests Work

Lab-developed tests (LDTs) are created and validated by individual laboratories, including academic medical centers and specialty reference labs.

These tests are regulated under the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA), ensuring quality standards.

LDTs fill critical diagnostic gaps when FDA-approved tests do not exist or have known limitations.

They allow laboratories to:

• Respond quickly to emerging pathogens
• Develop tests for rare diseases
• Customize testing for clinical needs

For infections like B. miyamotoi, they are often the only available diagnostic option.

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The Innovation Problem

Innovation in diagnostic testing depends on speed—something the current FDA process is not designed to provide.

The FDA approval process is lengthy and costly, often requiring years of development and significant financial investment.

For emerging infections affecting smaller populations, there may be little economic incentive to pursue FDA approval.

This creates a Catch-22: emerging infections need tests, but regulatory and financial barriers prevent their development.

Lab-developed tests help bridge this gap by allowing laboratories to develop and validate diagnostics while maintaining oversight through CLIA.

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Concerns About Limiting Testing Options

Lyme disease and related infections are increasing in both prevalence and geographic reach.

This is not the time to restrict access to diagnostic tools that have undergone rigorous evaluation.

“It is premature to require further regulatory oversight of the tests we need for emerging tick-borne illnesses,” says Dr. Daniel Cameron.

At a time when new pathogens are emerging and tick habitats are expanding, flexibility in testing is essential.

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The Public Health Impact

Without diagnostic tools, there is no way to measure the true scope of disease.

Accurate testing is essential for:

• Tracking disease prevalence
• Identifying geographic hotspots
• Allocating healthcare resources

For B. miyamotoi, the true burden of disease remains unclear.

How many cases are currently misclassified as Lyme disease? Which regions are most affected? These questions cannot be answered without reliable testing.

Restricting lab-developed tests would leave clinicians and public health officials without the tools needed to answer these critical questions.

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Frequently Asked Questions

Is there an FDA-approved test for Borrelia miyamotoi?
No. There is currently no FDA-approved test. Clinicians rely on lab-developed tests such as PCR, blood smear, and serologic methods.

How is B. miyamotoi diagnosed?
Diagnosis includes blood smear, PCR testing, detection in cerebrospinal fluid, and molecular methods—all lab-developed tests.

Why is this a concern?
Without FDA-approved tests, clinicians depend on specialty labs. Restricting these would make diagnosis of emerging infections nearly impossible.

What would happen if lab-developed tests were eliminated?
Clinicians would lose key diagnostic tools, innovation would slow, and patients would remain undiagnosed and untreated.

What regulates lab-developed tests?
They are regulated under CMS and CLIA, which ensure quality while allowing flexibility for emerging infections.

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Clinical Takeaway

The absence of an FDA-approved Borrelia miyamotoi test exposes a critical weakness in how we respond to emerging infections.

Borrelia miyamotoi, first identified in 2011, causes relapsing fever and symptoms similar to Lyme disease. Yet no FDA-approved diagnostic test exists.

Clinicians currently rely on blood smear, PCR, and molecular detection—all lab-developed tests.

If these tests are restricted, patients with emerging infections would become undiagnosable.

Tick populations are expanding. New pathogens are emerging. Climate change is extending exposure risk.

This is precisely when we need more diagnostic flexibility—not less.

Lab-developed tests allow clinicians to respond to emerging threats, support patient care, and improve public health surveillance.

Without them, both patients and the healthcare system are left in the dark.

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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