Lyme disease: a national problem
Lyme disease is the fastest growing vector-borne disease in the US according to the CDC. The infection is caused by the spirochete bacteria, Borrelia burgdorferi, and transmitted by the black-legged tick, which is often referred to as the deer tick. Generally thought of as a regional disease that is endemic in the Mid-Atlantic, Northeastern, and Upper Midwestern regions of the US, it is rapidly spreading into the Southeastern US, the mountain Western states, and into California making it a national problem.
Poor current testing methods
The current CDC recommended Lyme disease diagnostic test detects the body’s response to infection and not the infection itself. The 2-tier immunoassay test detects the presence of anti-Lyme antibodies in human serum, blood, or cerebral spinal fluid (CSF). Due to the slow production of antibodies in response to exposure to B. bergdorferi, the 2-tier test is prone to high false-negative rates (up to 60%), especially in patients who are tested < 30 days following infection, or those who have weak or suppressed immune responses. Since treatment is most effective with 6 weeks of exposure, identification of an active infection soon after exposure is critical.
Ionica's solution: IonLyme
Ionica Sciences has developed the IonLyme™ test to provide clinicians with the tools necessary to address this growing need. IonLyme™ directly detects Outer Surface Protein A (or OspA), a protein shed by the B. burgdorferi pathogen which is present only during active Lyme disease infections. While there are low levels of B. bergdorferi, the spirochete sheds OspA into the blood providing a target that unique to the target bacterium and found at detectable levels early in the course of the disease. This change in testing paradigm makes it possible to test earlier, follow the efficacy of treatment and determine if a patient has been re-infected, capabilities that are not available to the clinician with the CDC-recommended test.
The IonLyme assay uses a method based on highly specific DNA aptamers and highly sensitive Surface Enhanced Raman Scattering (SERS), producing a test is capable of rapidly and specifically detect OspA in serum samples obtained from human Lyme disease patients.