Veramarx Lyme Disease Test

United States Patent 10,274,491

Don't Miss a Diagnosis

Reduces Doctor and Patient Anxiety

Veramarx’s immunoassay of 10 inflammatory biomarkers has 92% sensitivity and 99% negative predictive value (NPV). This makes it very accurate, especially during the early phase of Lyme Disease when effective treatment is possible. Furthermore, with 99% negative predictive value, a negative result provides 99% certainty that it's a TRUE NEGATIVE, compared to current tests that miss 60% of the cases.  

 

Unlike the problematic two-tiered testing system currently recommended by the CDC (ELISA and Western Blot tests, which focus on antibody detection), Veramarx measures multiple biomarkers known to occur soon after infection. 

 

Why is the current testing approach so problematic? In patients with Lyme Disease, antibodies are often generated too late or not at all, meaning that current testing cannot detect the infection in its early stage. In contrast, Veramarx does not rely on antibodies, requires a single test, provides results faster, and does not need subjective expert evaluation and interpretation.  

 

Veramarx is the first test to enable the early diagnosis and intervention of Lyme Disease. This could vastly improve treatment and greatly reduce the long-term financial, societal, and personal impact of Lyme Disease.

Veramarx was developed at National Jewish Health Advanced Diagnostic Laboratory

For more than 30 years, National Jewish Health Advanced Diagnostic Laboratories has been a trusted name in diagnostics.  National Jewish Health provides contract research and clinical trial services to pharmaceutical, biotechnology and device manufacturers around the world as one of the leading clinical laboratories in the industry.   www.nationaljewish.org

Regulatory Pathway

 

Veramarx's Lyme Disease test will be offered as a traditional blood test through the National Jewish Advanced Laboratory's Clinical Laboratory Improvements Amendments (CLIA) lab.

The Veramarx Clinical Validation Study

 

Completed in 2016

Study Objective:

•Demonstrated specificity of the Veramarx test, showing separation of a variety of illnesses with overlapping symptoms from Lyme disease

•Demonstrated that the Veramarx test can detect Lyme disease in cases that cannot be diagnosed by other methods (i.e. cases that are both EM - Erythema Migrans a.k.a. Bulls Eye Rash – negative, and 2-tier negative)

Study Design:

•Specimens were prospectively collected from a study site in Virginia and retrospectively obtained from a study site in Massachusetts

•The Veramarx Clinical Validation study was designed to demonstrate sensitivity and specificity in a combination of patient cases; confirmed Lyme disease cases and cases with Lyme disease symptoms resulting from non-Lyme disease infections

Study Size & Results:

•The Veramarx Clinical Validation study consisted of 176 total cases with statistically significant results that demonstrated 92% sensitivity, 99% Negative Predictive Value, 89% accuracy and 81% specificity

Training Set/Validation Set:

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Up to 60% more definitive results

With a sensitivity of 92% and negative predictive value of 99%, the Veramarx Lyme disease test provides up to 60% more definitive results companies to the current Two-Tiered tests.

 

Not
Lyme disease
Not
Lyme disease
Lyme disease
Lyme disease