by Timothy Sellati, Ph.D., Chief Scientific Officer, GLA
Lyme disease is the most commonly occurring vector-borne disease in the United States. The number of cases reported to the Centers for Disease Control and Prevention (CDC) has increased steadily over the past 25 years. The actual number of cases that occur annually is difficult to pinpoint given several shortcomings associated with the current FDA-approved two-tier serologic testing protocol. Laboratory methods for the diagnosis of Lyme disease fall into two categories: (1) direct methods to detect the Borrelia burgdorferi,bacterium, the causative agent of Lyme disease, and (2) indirect methods that detect the immune response (antibodies) against it. Shortcomings associated with the current testing protocol include low sensitivity in those newly infected, subjectivity in the interpretation of Western immunoblot results, and the inability of the test to discriminate between current active infection versus past exposure.
Despite the annual estimated number of cases being 300,000 to 329,000 nearly 3.4 million Lyme serologic tests are performed each year. The predictive value of a test is determined by its sensitivity, specificity, and the prevalence of the disease in the population to be tested. Given the Lyme testing protocol’s shortcomings, coupled with sometimes inappropriate use of the test (prior to production of antibodies against B. burgdorferi) and the ability of the pathogen to shut down antibody production during later disease, there is an unacceptably high rate of false-negative and false-positive results. The most effective treatment options can only be pursued when rapid and accurate diagnosis occurs. Compounding the challenge faced by physicians in choosing the correct course of treatment is the fact that the black-legged (“deer”) tick, Ixodes scapularis, also serves as a vector for Powassan virus, Borrelia miyamotoi and mayonii infections, and the causative agents of anaplasmosis, babesiosis. Lack of knowledge about the co-infection status of an individual can delay provision of appropriate treatment(s) to combat all the symptoms experienced by a patient. Recognizing that the longer a pathogen remains in the body the more likely the severity and duration of disease will be greater, there is a critical medical need for rapid, sensitive, and specific diagnosis.
It is for this latter reason that so much excitement surrounds the announcement that Global Lyme Diagnostics (GLD), which launched its ground-breaking Lyme diagnostic in 2017, and is now launching its tick-borne co-infections diagnostic test. This new co-infection panel offers physicians the ability to test patient samples for evidence of the most common tick-borne diseases (i.e., Anaplasma, Babesia microti and B. duncani, Bartonella henselae and B. quintana, and Rickettsia including the Spotted Fever Group).
According to GLD’s CEO, Mickey Ramchandani, “The new co-infection test is the most affordable on the market with the quickest turnaround time from test to results and allows physicians to custom-pick the co-infections they want to test for—not forcing them to run a battery of tests for a co-infection they have already deemed unnecessary through their own analysis.” Ramchandani also states that “Our mission at Global Lyme Diagnostics has been to reduce false negatives plaguing the Lyme testing assays with a test that is not only reliable but is also affordable to a wider population. We are now expanding our test menu to also include multiple different co-infections that result from tick bites.”
GLD licensed the technology platform and related intellectual property surrounding chimeritopes developed by Richard T. Marconi, Ph.D., a Professor in the Department of Microbiology and Immunology at Virginia Commonwealth University. Dr. Marconi also serves on the Scientific Advisory Board of Global Lyme Alliance.
As GLA’s Chief Scientific Officer, Dr. Sellati leads GLA’s research initiatives to accelerate the development of more effective methods of diagnosis and treatment of Lyme and other tick-borne diseases.