Lyme disease: undetected, underdiagnosed and undertreated
Lyme disease is a tick-borne bacterial infection that, if left untreated, can cause chronic joint inflammation, neurological disorders and cognitive defects. For patients who are infected with the bacteria that cause Lyme disease, early diagnosis and appropriate treatment can prevent or reduce these complications and their significant associated costs.
According to The Centers for Disease Control and Prevention (CDC), in the United States approximately 30,0001,2 cases of Lyme disease are reported each year. However, the CDC estimates the actual number is closer to 360,0001,2, but is severely under-reported due to poor diagnostic testing.
Approximately 3.4 million tests1,2 are run for Lyme disease each year including serology tests, polymerase chain reaction (PCR) techniques and blood culture. These tests are labor-intensive, can take weeks to process and are subject to high false negative rates due to their inability to detect the disease. Because of these limitations, patients are frequently misdiagnosed or face delayed diagnosis. Up to 90%1,2 of patients with Lyme disease go undetected altogether.
Because of the poor diagnostic testing currently available for Lyme, the CDC recommends that the diagnosis remain a clinical one, based on a patient’s symptoms and history, and that blood tests should only be used to provide supporting evidence for the diagnosis.
The T2Lyme Panel, which is being developed through a partnership between T2 Biosystems and Canon US Life Sciences is being designed to identify the bacteria that cause Lyme disease directly from a patient’s blood, without the need for blood culture. The test panel is expected to be run on the FDA-cleared T2Dx® Instrument, the same instrument currently used to run our FDA-cleared T2Candida® Panel and our CE Marked T2Bacteria®Panel*.
We anticipate the T2Lyme Panel will benefit from similar advantages provided by our T2MR® technology as the T2Candida Panel, including high sensitivity, high specificity, ease of use and rapid time to result.
We are developing the T2Lyme Panel to provide accurate and timely diagnosis of Lyme disease, which may help better manage patients, lead to better outcomes and reduce or eliminate the significant costs associated with the disease.
*Currently not commercially available in the US.
The T2Dx Instrument and T2Candida Panel have received marketing authorization from the U.S. Food and Drug Administration. All other T2 Biosystems products are considered investigational and for research use only.
1. Centers for Disease Control and Prevention. Summary of notifiable diseases, United States, 2008. Morb mortal wkly rep 2010; 57:26.
2. Hinckley, A. F., Connally, N. P., Meek, J. I., Johnson, B. J., Kemperman, M. M., Feldman, K. A., … & Mead, P. S. (2014). Lyme disease testing by large commercial laboratories in the United States. Clinical infectious diseases, ciu397.