Two significant patents that allow increased sensitivity and specificity of immunodiagnostic procedures were issued. Specially developed polyethylene glycol-peptide conjugates were utilized as antigens. The patent principles were applied to the successful development of a new Lyme Disease Test.
In our invention, a new polyethylene glycol (abbreviated PEG) copolymer system was designed as the carrier of the disease recognizing peptide epitopes that could be used in a serological test. The resulting PEG-peptide conjugates prepared in collaboration with our university research group were used in an immunoassay for early stage Lyme disease diagnosis.
To achieve strong and stable antigen-antibody binding for the disease specific epitope peptides (which were also discovered through our research program), we designed the new PEG-peptide conjugate system with multiple copies of epitope peptides attached in a favorable geometric arrangement to avoid steric hindrance. A commonly used signal molecule in immunoassay is biotin, an extremely sensitive detection system component. Only a small portion of the attachment sites in the polymer are needed to attach the biotin signal molecules. The large portion of the remaining attachment sites could be used for the disease recognizing epitope peptides. Many diagnostic advantages were achieved with the polyvalent antigen created. Most notably, as a result of the significant improvement in antibody binding that was obtained, increased sensitivity and specificity of the immunoassay was observed.
The patent applications can be used to diagnose microbial diseases in which early, reliable detection of low concentration early antigens is an advantage. Also, the patent principals can be applied to detect various analytes of medical, bioterrorism or biopharma importance. The company anticipates that application of the patent methods to the immunoassay detection of cancer antigens will provide increased sensitivity and specificity of these procedures.
The company would consider licensing the technology or collaborating in the development of applications for the users interest. Please call or email for additional information.
A New Lyme Disease Test
Lyme Disease is an infection caused by the microbial spirochete Borrelia burgdorferi, which is transmitted by deer ticks. Soon after infection, there is often a bulls-eye rash (termed medically, erythema migrans) as well as fever, fatigue, malaise, headache, stiff neck, arthralgia and myalgia. If the distinctive rash is not present, the early diagnosis of Lyme disease is made difficult as the constitutional symptoms are non-specific. Many of the available diagnostic tests also lack sufficient sensitivity and specificity to be relied upon for diagnosing early Lyme disease.
In our work, we developed well defined, Lyme disease specific, individual epitopes composed of small disease specific peptides as the antigen source to test for the presence of antibodies to the Borrelia burgdorferi organism. Antibodies are the protective proteins the body forms in response to microbial infection or to other foreign substances to which an individual may be exposed. The ability of our defined epitope peptides to reliably detect antibodies to Lyme disease at the important earliest states of the disease as well as at later stages led to an enhanced accuracy in the serodiagnosis of Lyme Disease.
Cenogenics is introducing two established products with updated labeling for professional veterinary use. Our Stool Occult Blood Kits and our Chemview-10™ Urinalysis Test Strips are well known, FDA registered medically used diagnostic systems. Both test systems are also used routinely in veterinary practices. The Stool Occult Blood Vet Kits and the Chemview-10™ Vet Urinalysis Test Strips will be introduced in the Fall of 2009 with labeling instructions for veterinary use.