Data show strong evidence that Lyme disease-causing bacteria exist in blood and that T2MR has superior sensitivity to conventional PCR methods for direct detection in blood
LEXINGTON, Mass., June 01, 2017 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, today announced that a new study, “T2 Magnetic Resonance-based Direct Detection of Three Lyme Disease-Related Borrelia Species in Whole Blood Samples,” was published in the Journal of Clinical Microbiology. As the United States enters a predicted bad tick season, this peer-reviewed study provides insights into the future of Lyme disease diagnostics. T2 Biosystems expects to complete pre-clinical studies for the T2MR-powered T2Lyme™ Panel in 2017, which is expected to lead to a clinical trial for FDA submission in 2018, in partnership with Canon U.S.A.
"This study shows strong evidence that Lyme disease-causing bacteria exist transiently in blood," said co-author Thomas Fritsche, M.D., Ph.D. Marshfield Clinic, Marshfield, Wisconsin. "T2MR is the only technology proven sensitive enough to directly detect these bacteria."
This research demonstrates that T2MR is able to detect Lyme disease-causing bacteria in clinical samples and was found to be highly sensitive with extremely low levels of detection. T2MR detected both confirmed cases of Lyme disease that were tested in this study in addition to 17 samples from patients with probable Lyme disease based on presentation and symptoms. The conventional PCR method used in the study only detected 1 case of Lyme disease-causing bacteria whereas in comparison T2MR detected that case plus 7 others. In addition, analytical sensitivity was determined from blood spiked with known concentrations of spirochetes, and the assay’s limit of detection was found to be in the single cell/mL range: 5 cells/mL for B. afzelii and 8 cells/mL for B. burgdorferi and B. garinii, significantly lower than the limits of detection of >100 cells/mL reported for conventional PCR methods.
"T2MR is a method to detect Lyme spirochetes in whole blood that promises rapid and reliable sample-to-answer results,” said co-author Steven M. Callister, Ph.D., Gundersen Health System, La Crosse, Wisconsin, "and this study offers insight to how this diagnostic may improve clinical care for individuals with Lyme disease."
The current standard of detection for Lyme disease is serology, which detects antibodies raised by the body in response to the disease. There is no diagnostic based on direct detection of Lyme disease-causing bacteria that is FDA cleared. The CDC recommends a two-tiered approach but the interpretation of serologic tests can be subjective, and high variability in test results has been reported between laboratories. This two-tiered approach detects two antibodies that require 1-2 weeks and 4-6 weeks to reach detectable levels, so there exists a window where diagnosis of early Lyme disease is not possible using the two-tiered method.
Direct detection has the potential for clinical importance not only because a current infection by Lyme disease-causing bacteria can be determined with certainty, but because it can also deliver results faster, well inside the up to two-months required for the two-tiered serology approach.
In addition, Lyme disease is significantly underreported; it is estimated that current reporting of Lyme disease cases is off by a factor of ten in the United States. 20,000-30,000 cases are confirmed annually, but estimates indicate that there may be closer to 300,000 new cases yearly according to research from the CDC.
The Journal of Clinical Microbiology paper was published online at http://jcm.asm.org/content/early/2017/05/25/JCM.00510-17.abstract.
About T2 Biosystems
T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With the FDA-cleared T2Dx® Instrument and T2Candida® Panel targeting sepsis, a life-threatening infection, and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2MR technology to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of patient sample types, including whole blood. For more information, please visit www.t2biosystems.com.
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