The new Ceres Lyme test, which is based on nanotechnology, is well on its way to getting FDA approval.The new urine test was developed by Temple Douglas at George Mason University three years ago, who pursued a test for Lyme disease because of personal interest.
Her idea for the test originated when Douglas was a high school intern at George Mason University in Virginia. She wondered whether a technique researchers were working on to test for microscopic cancer particles might be used to test for Lyme disease.
“I was in the right place at the right time,” she told CBS News. “I was aware of the issues with the Lyme disease test because of people in my family. Two people in my family at that time had Lyme disease.” Douglas is now a graduate student, and her brain child, “Nanotrap LA”, is the first commercial product for Ceres.
As readers know, Lyme disease is difficult to diagnose not only because only a small percentage of people get the telltale rash after a tick bite, but also due to the lack of reliable testing. This is a compounding problem because the more people who fall through the cracks and fail to get sufficient treatment early on, the more people who develop persistent chronic Lyme which is far more difficult to treat.
So how does “Nanotrap LA” work?
According to Ceres (acommercial lab associated with George Mason University) the nano technology collects a part of the bacteria called Osp A (outer surface protein) which is shed after the bacteria is processed through the kidney, and evaluates those particles. The amount of bacteria in urine is very small, especially at the beginning of the infection, however, the beauty of this test is that the nano technology is able to find even the smallest amount of Osp A and process it. Even though this new test relies on the western blot assay to evaluate the findings, so far it does not seem to share the equivocal nature of the blood test, posting 100% accuracy in the published study.
It seems crazy that such an important test would have any difficulty getting to market (technically it can be used now – see CERES website for ordering instructions), but it is considered experimental until it gets FDA approval, and Dr. John Aucott, director of the Johns Hopkins Lyme Disease Clinical Research Center, cautions that the research is still preliminary.
Will this test replace traditional testing in IDSA’s treatment guidelines and mainstream medicine? I think it will be an uphill battle. It seems the whole world has suppressed the successful blood culture developed at Advanced Lab Services a decade ago. The CDC attacked the lab so vehemently that the state of New York actually made it illegal to use (unprecedented!) I believe the reason the CDC protests so loudly is due to the overwhelming number of results from chronic Lyme patients who are considered to have PTLDS (Post Treatment Lyme Disease Syndrome) by CDC, are found to have active infections in spite of the recommended 2 – 4 weeks of abx, which disproves their long-held position that Lyme is hard to catch and easy to treat.
Fortunately the “establishment” will have to bow to science eventually and people like Temple Douglas will open new doors in scientific inquiry which will prevent unnecessary suffering.