As Lyme disease increases at an alarming pace and fears that undiagnosed cases are creating a medical iceberg, scientists are working with speed and diligence to unlock the secret to a more effective test to head off an even wider medical crisis.
The challenge is to develop a test that is not only quick and accurate, but that is so sensitive that it cannot be fooled into failing to diagnose the illness, or to misdiagnose it as something else.
Scientists at TrovaGene, Inc., (formerly Xenomics, Inc.) a developer of transrenal molecular diagnostics, are now working on a non-invasive, urine-based test to diagnose and monitor various diseases and disorders, and which company officials say can be applied to the corkscrew-shaped bacterium Borrelia burgdorferi, better known as Lyme disease, and if successful, provide the most effective test available.
“We have begun research and expect significant results in 2011,” said Thomas Adams, TrovaGene’s Board Chairman.
"The critical distinction from existing tests is that the TrovaGene technology provides a more highly-sensitive method of detection by finding and analyzing "ultra short" (20-50 base pair) nucleic acids in a urine specimen."
“Looking for these short DNA sequences should result in a highly reliable test for the disease,” said Adams.
The testing involves the collection of a urine sample from the patient, thus eliminating the need for an invasive blood drawing procedure.
Lyme disease, so coined because the initial outbreak, spread by the Deer tick, occurred near the Connecticut river town of Old Lyme. In the latest report by the Centers for Disease Control and Prevention (CDC), 28,921 people were stricken in 2008. But authorities estimate the real number could be 10 times greater because of undiagnosed, misdiagnosed or simply unreported cases.
The symptoms can include headaches, fatigue, joint pain, speech and vision impairment and sleep abnormalities. But accurately diagnosing the disease is another story.
“The disease can be effectively treated with antibiotics if properly diagnosed,” said Adams. “But it has been difficult to diagnose with current testing tools and it can be mistaken for chronic fatigue syndrome, rheumatoid arthritis, multiple sclerosis, Alzheimer's disease, Bell's palsy or even Lou Gehrig's disease (ALS)."
When people do not receive treatment because of non-or-misdiagnosis and the disease lingers in the body, that’s when the condition becomes chronic, Adams said, and the medical agony multiplies.
“We expect that with our urine analysis, results will be available within 24 hours of taking the test,” he added. “We are looking forward to our test providing a substantial breakthrough in the area of Lyme disease detection.”