The FDA Testing Gap for Emerging Tick-Borne Diseases

Where is the Borrelia miyamotoi FDA test? 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 clinician’s 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.

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.

The emergence of B. miyamotoi illustrates a fundamental problem with restricting diagnostic testing to FDA-approved methods only: new pathogens emerge faster than the FDA approval process can accommodate them. By the time a test receives FDA approval, years may pass during which patients cannot be properly diagnosed.

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No Borrelia miyamotoi FDA Test Available

There is currently no FDA-approved test for Borrelia miyamotoi. This means all existing diagnostic methods for this infection are lab-developed tests—precisely the tests the FDA has proposed regulating more heavily or eliminating.

The tick population is exploding and expanding to new regions. Complex vector-borne organisms are emerging, posing a threat to public health, and 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.

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Current Testing Methods for Borrelia miyamotoi

Researchers have had to diagnose B. miyamotoi based on blood smear, direct detection of spirochetes in cerebrospinal fluid and follow-up polymerase chain reaction (PCR), and molecular detection of B. miyamotoi DNA in acute whole blood from patients. These are all non FDA-approved tests.

Without a Borrelia miyamotoi FDA test, clinicians face significant challenges in diagnosing this emerging infection.

So where would these patients be if the FDA insisted on only its tests being utilized? They would be undiagnosed. Their symptoms would be dismissed. Their illness would progress untreated.

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How Lab-Developed Tests Work

Lab-developed tests (LDTs) are diagnostic tests developed and validated by individual laboratories, typically academic medical centers or specialty reference labs. These tests undergo rigorous evaluation processes and adhere to regulations by the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA).

LDTs fill critical diagnostic gaps when FDA-approved tests don’t exist or when existing FDA-approved tests have known limitations. They allow laboratories to respond quickly to emerging pathogens, develop tests for rare diseases, and customize testing approaches for specific clinical needs.

For emerging tick-borne infections like B. miyamotoi, LDTs are often the only diagnostic option available. Without them, physicians would have no way to confirm diagnosis, guide treatment, or track disease prevalence.

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The Innovation Problem

Heavily regulating or eliminating lab-developed tests would stifle innovation in diagnostic testing. Small specialty laboratories and academic medical centers—the entities most likely to develop novel tests for emerging infections—would face prohibitive regulatory burdens.

The FDA approval process for diagnostic tests is lengthy and expensive, often requiring years of clinical trials and millions of dollars in development costs. For rare or emerging infections affecting relatively small patient populations, the financial incentive to pursue FDA approval may not exist.

This creates a Catch-22: emerging infections need diagnostic tests, but the economic and regulatory barriers prevent their development. Lab-developed tests solve this problem by allowing laboratories to create and validate tests without going through the full FDA approval process, while still maintaining quality standards through CLIA oversight.

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Concerns About Limiting Testing Options

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.

The timing is particularly concerning. Tick populations are expanding geographically. New tick-borne pathogens are being discovered regularly. Climate change is altering tick habitats and extending tick seasons. This is precisely when we need maximum flexibility and innovation in diagnostic testing—not additional regulatory restrictions.

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The Public Health Impact

The implications extend beyond individual patient care. Without accurate diagnostic testing for emerging tick-borne infections, public health surveillance becomes impossible. We cannot track disease prevalence, identify geographic hotspots, or allocate resources appropriately without the diagnostic tools to identify cases.

For B. miyamotoi specifically, we don’t yet know the true disease burden. How many patients are infected? Which regions have the highest prevalence? What percentage of tick-borne illness currently attributed to “Lyme disease” is actually B. miyamotoi? These questions require diagnostic testing to answer.

Eliminating or heavily restricting lab-developed tests would keep us in the dark about emerging infections at precisely the moment when we need better surveillance and understanding.

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Frequently Asked Questions

Is there an FDA-approved test for Borrelia miyamotoi?
No. There is currently no Borrelia miyamotoi FDA test available. Clinicians must rely on lab-developed tests including PCR, blood smears, and serologic testing—all of which would be at risk if the FDA eliminates lab-developed tests.

How is B. miyamotoi currently diagnosed?
Diagnosis relies on blood smear, direct detection of spirochetes in cerebrospinal fluid, PCR testing, and molecular detection of B. miyamotoi DNA in whole blood. All of these are lab-developed tests, not FDA-approved methods.

Why is the lack of FDA testing a concern?
Without FDA-approved tests, clinicians depend on specialty labs and lab-developed tests. If the FDA eliminates these, diagnosing emerging tick-borne infections like B. miyamotoi would become nearly impossible, leaving patients undiagnosed and untreated.

What would happen if lab-developed tests were eliminated?
It would severely restrict clinicians’ ability to diagnose Lyme disease and co-infections, stifle innovation in diagnostic testing, discourage research into new diagnostic solutions, and leave patients with emerging infections without any diagnostic options.

What regulations currently govern lab-developed tests?
Lab-developed tests must comply with regulations by the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA). These ensure quality standards while allowing flexibility for emerging infections.

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Clinical Takeaway

The absence of an FDA-approved test for Borrelia miyamotoi highlights a fundamental tension in diagnostic testing regulation. B. miyamotoi was only recently identified in 2011 and has since been found across the United States, Netherlands, Japan, and other regions. It causes relapsing fever and symptoms similar to Lyme disease, requiring accurate diagnosis for appropriate treatment. Yet no FDA-approved test exists. Clinicians currently diagnose B. miyamotoi using blood smear, direct detection of spirochetes in cerebrospinal fluid, PCR testing, and molecular detection of bacterial DNA in whole blood. Every single one of these methods is a lab-developed test—not FDA-approved. If the FDA succeeds in eliminating or heavily restricting lab-developed tests, these diagnostic options would disappear. Patients with B. miyamotoi infection would become undiagnosable. The broader implications are equally concerning. Tick populations are exploding and expanding to new geographic regions. New tick-borne pathogens are emerging regularly. Climate change is extending tick seasons and altering habitats. This is precisely when we need maximum diagnostic flexibility and innovation—not additional regulatory restrictions that would prevent laboratories from developing tests for emerging infections. Lab-developed tests fill critical gaps when FDA-approved tests don’t exist or have known limitations. They undergo rigorous evaluation and must comply with CMS and CLIA regulations ensuring quality standards. They allow academic medical centers and specialty reference labs to respond quickly to emerging pathogens, develop tests for rare diseases, and customize testing approaches for specific clinical needs. The FDA approval process for diagnostic tests requires years of clinical trials and millions of dollars in development costs. For rare or emerging infections affecting relatively small patient populations, the financial incentive to pursue FDA approval often doesn’t exist. This creates a Catch-22: emerging infections need diagnostic tests, but economic and regulatory barriers prevent their development through traditional FDA pathways. Without lab-developed tests, emerging tick-borne infections would go undiagnosed. Public health surveillance would become impossible. We couldn’t track disease prevalence, identify geographic hotspots, or allocate resources appropriately. The growing number of patients infected with Lyme disease and co-infections would pay the price. As would all those, still undiagnosed.

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