Lyme disease is one of the few infections where patients are often diagnosed too late — not because they waited, but because testing could not detect the infection until later stages – if at all.

A new Lyme blood test called LymeSeek could change that. It aims to revolutionize Lyme diagnostics by delivering significantly higher accuracy, especially in early disease detection — where current tests often fall short.

Holly Ahern, MS, MT, Chief Scientific Officer at Aces Diagnostics, discusses LymeSeek. For more information, visit https://www.acesdiagnostics.com/lymeseek

According to data presented at the 2025 Association for Diagnostics and Laboratory Medicine meeting, LymeSeek demonstrated over 90% sensitivity and specificity in detecting Lyme disease across all phases of illness — from early localized to post-treatment.

That’s a significant improvement over standard two-tier testing, which often misses early cases when treatment matters most. Reliable testing is particularly important since an estimated 30% of patients never develop the classic bull’s-eye rash, which most practitioners rely on for diagnosing the disease.

Why Current Lyme Testing Often Fails

Current Lyme disease tests miss many infections — especially early ones — mainly because of how they work and what they’re looking for.

They don’t detect the bacteria itself

• Most current tests (like the CDC-recommended two-tier testing) look for antibodies your immune system makes against Borrelia burgdorferi. However, it can take several days to weeks for antibodies to develop. That means serologic testing can produce false negatives — especially in the first 2–4 weeks after infection. This is one of the biggest frustrations for providers treating patients in Lyme endemic areas. Many patients never test positive

The CDC’s recommended two-tier system is rigid and outdated

• Patients are initially given an ELISA test. If positive or equivocal, they then receive the Western blot. If either of these test results are negative, the patient supposedly doesn’t have Lyme disease – even when they might.

• This system was designed decades ago mainly for surveillance, not for highly sensitive early diagnosis.

Borrelia’s biology makes testing tricky

• The bacteria changes the proteins it expresses at different stages of infection, meaning antibody targets aren’t consistent.

• It can hide in tissues and reduce exposure to the immune system (immune evasion), which delays or blunts antibody production.

Strain and species variation

• U.S. tests focus mainly on B. burgdorferi sensu stricto. If someone is infected with another species like: B. mayonii, B. garinii, or B. afzelii, testing may not detect those antigens, leading to a false negative result.

Past infection vs. active infection confusion

• Once antibodies form, they can persist for months to years after treatment. Therefore, testing cannot distinguish whether an infection is new, ongoing, or old. A patient may have an old infection that has resolved and doesn’t require treatment.

What Makes This New Lyme Blood Test Different?

The new Lyme blood test uses a multiplexed antigen assay—testing for 10 different immune responses at once. Then, a machine learning algorithm interprets the results. This approach improves both sensitivity and specificity, especially in early disease when antibodies are still forming.

In head-to-head comparison:

1. In early disease (0–72 hours after EM rash), LymeSeek detected 100% of cases vs. just 37% with standard testing.

2. In post-treatment Lyme (6+ months after infection), LymeSeek identified 97% of cases vs. 46% with standard tests.

That means better detection without waiting for seroconversion, and better confirmation of past infection when patients present with persistent symptoms.

Will This Test Change Lyme Disease Care?

It could—eventually.

This new Lyme blood test may help:

1. Identify early Lyme before antibodies form

2. Confirm cases when no rash is present

3. Support diagnosis in patients with ongoing symptoms after treatment

Is the New Lyme Blood Test Available Now?

🚫 It is not yet FDA-approved or available for patient ordering through clinics or commercial labs.

ACES Diagnostics is currently working with the FDA on clinical trial pathways. The test has received a De Novo classification, meaning it’s being evaluated as a novel diagnostic tool—not just compared to current testing.

If approved, LymeSeek could be a game-changer for early Lyme detection and for patients with post-treatment symptoms who need better answers.

Final Thoughts

A new test can’t fix every challenge that comes with Lyme disease. But it could mean getting answers sooner, missing fewer cases, and giving doctors more confidence in diagnosing.

Links

1. Clinical Testing and Diagnosis for Lyme Disease

2. LymeSeek: Blood test with 90% accuracy

3. Why I Treat Babesia Even if the Tests Are Negative