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"This study shows strong evidence that Lyme disease-causing bacteria exist transiently in blood," said co-author
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
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
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
About T2 Biosystems
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the performance of the Company's diagnostic products and the ability to bring such products to market. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. For more information on risk factors for T2 Biosystems, Inc.’s business, please refer to the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 15, 2017, under the heading “Risk Factors,” and other filings the Company makes with the Securities and Exchange Commission from time to time. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.
Darlene Deptula-Hicks, T2 BiosystemsSVP & Chief Financial Officer firstname.lastname@example.org 603-553-5803 Media Contact: Matthew McKillip, T2 Biosystemsmmckillip@t2biosystems.com 518-577-3466 Investor Contact: Tucker Elcock, Teneo Strategy Tucker.Elcock@teneostrategy.com 212-886-9319