While the medical and health community is putting a spotlight on diseases like Zika, Ebola and tuberculosis, another disease, transmitted by ticks, is getting little notice: Lyme disease.
The ticks that carry Lyme disease are spreading rapidly across the U.S. and are now located in nearly half of the country. The CDC estimates that 300,000 Americans are infected with Lyme disease. But the number of sufferers may be much higher, some Lyme disease experts believe. About 2.8 million have been diagnosed and a whopping 1.55 million are suffering lingering effects from the disease, also known as chronic Lyme disease or Post-Treatment Lyme Disease Syndrome, according to Dorothy Kupcha Leland, vice president for education and outreach for LymeDisease.org.
That's a medical crisis when you consider that 40 percent of Lyme patients suffer from long-term health problems that can include brain and nerve damage as well as spinal cord and heart problems. Actor and songwriter Kris Kristofferson's Lyme disease diagnosis made headlines a few months ago when he was originally misdiagnosed as having Alzheimer's.
Taking care of these patients is costing the health-care system between $712 million and $1.3 billion a year, according to researchers at Johns Hopkins Bloomberg School of Public Health.
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Part of the problem is that Lyme disease is very hard to detect and the testing is not always accurate. Many sufferers show no symptoms until it is too late for a single course of antibiotics to work. Current testing looks at the response of the patient to the disease rather than looking at the presence of the disease in the body. The symptoms of the early stages of Lyme disease, such as fatigue and joint pain, also mimic the symptoms of other diseases, such as arthritis, which make it hard to diagnose correctly. That's why it typically takes two years and five doctor visits before most patients get diagnosed, reports the International Lyme and Associated Diseases Society.
In response, researchers are developing new tests to detect the crippling disease that can cause long-term effects such as brain, nerve, spinal cord and heart problems due to misdiagnoses.
Ceres Nanosciences, a diagnostics company in Virginia, has developed the urine-based Nanotrap Lyme Antigen test for detecting Lyme disease. The revolutionary technology could help in detecting other diseases, like Ebola and tuberculosis, which is why the Bill and Melinda Gates Foundation has given over $1 million to the company for research. Just last week the company announced it plans to begin Series A funding for $9 million, $3 million of which it already has, to put toward funding a market release of the test. The funding will be used to help get FDA approval.
The test is revolutionary because of its nanotrap technology, created at George Mason University. Previous urine tests in the market were not successful, because they could not measure the Lyme antigen that the infection produces in the urine at the level that nanotrap technology can, said Ross Dunlap, co-founder and CEO of Ceres.
Dunlap said the company was inspired to create the test because they saw how dissatisfied the general public was with the current two-tiered testing for Lyme disease, the ELISA and western blot methods. In 2013, Virginia became the first state to require doctors treating patients with Lyme disease to disclose in a statement the inaccuracies with the current available testing before they are tested.
"The two types of testing are certainly not perfect," said Dr. Paul Mead, chief of epidemiology and surveillance activity at the Centers for Disease Control and Prevention. He said that the immune response to the infection may take four to six weeks to develop. Which means that people tested before four to six weeks may test negative for the infection when the antibodies haven't had enough time to develop.
A proper diagnosis in the early stages could mean the difference between successfully treating the patient with an initial round of antibiotics or having them live with lingering effects of the disease for years.
This is not the first urine antigen test on the market. For decades there have been many companies who have tried to use urine-based testing and have failed, Dr. Mead said. Past urine tests have failed because they were not concentrated enough and were unable to measure the small antigen amount that is present in the urine.
What's so scary about Lyme disease is how it infiltrates the body and slowly disturbs the immune system. Lyme disease is an infection caused by the bacteria Borrelia burgdorferi that can affect any organ and system of the body. Blacklegged ticks are known to transmit the infectious disease. Because their bites are not painful, people can be infected with the disease without knowing it. The only sure way to recognize an infectious tick bite is to notice the erythema migrans or bull's-eye rash. However, less than 50 percent of people who are bitten notice a rash, according to Dr. Samuel Shor, the president of International Lyme and Associated Diseases Society.
There are five subspecies — more than 100 strains in the United States and 300 strains worldwide of the bacteria — according to the ILADS website. These different strains allow the bacteria to evade immune system detection. The bacteria, in some cases, can alter its protein coat. If the bacteria cannot be identified properly, it stays in the body for a longer period of time and continues to change structure. This accounts for many false positives in the testing of Lyme disease.
According to the CDC, untreated Lyme disease in pregnant women can be dangerous to unborn children. If left untreated, Lyme disease during pregnancy may infect the placenta and could also cause possible stillbirth. The recommended antibiotic treatment is encouraged for pregnant women who have tested positive for the disease. Children are also prone to the disease because they generally spend long periods of time outside. They are also treated with the same form of antibiotic treatment.
It's very difficult to measure the antigen because there is a very low concentration of it in the urine, Dunlap said. Localized and concentrated nanotrap technology greatly increases the sensitivity of Lyme antigen detection, which makes it easier to detect and therefore treat. (The Journal of Translational Medicine published a study using the test, which can be found here.)
The nanotrap technology looks for the biomarker of the infection — a vastly different approach from the current two-tiered method that tests the antibodies. Antibodies are made by the body in response to a disease and show whether or not a patient has been exposed to an infection, not the infection itself, said Dr. Shor. Early stage detection is crucial for patients suffering from Lyme disease, and it's the same stage that the nanotrap technology is designed to work best in.
It's hoped new technology will dramatically help detection so they can start treatment — with antibiotics — as early as possible. This is critical since the bacteria that causes Lyme disease is known to morph itself into different strains and some doctors worry it may turn into superbugs in patients exposed to long-term antibiotic use.
— By Diana Pryor, CNBC news associate