- The IGeneX Advantage
- Tests and Panels
- Understanding the Test
It all began after 3M sold its Diagnostics Division in 1991 and the leading pioneer in Lyme disease, Dr. Nick Harris, formed IGeneX with a small team of seven people. Dr. Harris’ most significant contribution has been to those with Lyme and associated tick-borne diseases that had been misdiagnosed or remained undiagnosed for many years. Dr. Harris spent hours upon hours talking with patients and listening to their stories. Many had compelling historical and clinical evidence of Lyme disease but were testing negative on the commercially available tests. Because of the thousands of people misdiagnosed and mistreated, Dr. Harris knew that this had to change. Too many lives were being needlessly destroyed by a treatable condition. Physicians were equally frustrated because there were no good tests to be found, and their patients were seriously ill and not getting the proper treatment necessary. Dr. Harris realized early on that there was an urgent need for more sensitive Lyme tests. With his steadfast dedication to the scientific diagnosis of Lyme disease, he introduced groundbreaking laboratory testing to the scientific community with new diagnostic tools that have greatly improved the ability of physicians to diagnose these often debilitating diseases. He also learned that many physicians were not trained adequately on the diagnosis and treatment of Lyme disease. Dr. Harris was instrumental in the formation of the “International Lyme and Associated Diseases Society” (ILADS). This organization is at the forefront of training physicians to recognize and treat tick-borne diseases and become Lyme literate physicians. His dedication ensured that future generations of physicians would receive the knowledge to provide the much-needed care for patients suffering from tick-borne diseases.
As scientific research and knowledge of the causative organism of Lyme disease increased at a feverish pace in the late 1990s, it became clear to Dr. Shah that the commonly accepted testing criteria for Lyme disease were both too restrictive and incomplete. As she performed more research into Lyme disease testing it became obvious that the CDC criteria were not adequate to serve the population that was being infected by Lyme. By working in close consultation with top scientists vested in Lyme research, physicians who were treating patients, hands-on development in the lab and years of evidence and validation studies, Dr. Shah and her team have developed their own in-house testing criteria. By using a wider spectrum of both relevant proteins found throughout all the stages of infection and more strains of the organism that are found in a wider distribution in the world, more true positives have been found without sacrificing specificity.
As we have learned more about B. burgdorferi, other Borrelia, and the co-infecting organisms throughout the years that cause Lyme disease, we have continued to increase our menu of tests for tick-borne related diseases. Click here to learn more about our testing criteria. We were the first group to identify Borrelia burgdorferi in ticks in California. We were also the first to identify Babesia microti in New York, Switzerland, and Australia, using our exclusive patented FISH technology. Now we are the first to introduce Relapsing Fever Western Blot testing.
Relapsing Fever mimics symptoms of Lyme disease. This issue has become a challenge for physicians finding suspected Lyme patients negative on standard tests. We now know that there are two groups of Borrelia known to cause disease in humans, including B. burgdorferi sensu lato that causes Lyme disease and the Relapsing Fever Borrelia group that causes tick-borne Relapsing Fever. Through commitment and steadfastness, IGeneX is the only lab today that accurately differentiates between the two. Click here to learn more about our type of tests.
At IGeneX, we excel in research and development. We spend an industry leading excess of 15 to 20 percent of our net profits on research and development to continuously improve our diagnostic testing. We look for more and detect more without a corresponding loss in specificity, no matter when patients were exposed to the tick-borne pathogen.