LEXINGTON, Mass., Sept. 26, 2018 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, announced today new data suggesting the T2Lyme Panel™ is more accurate than other diagnostics for identifying Borrelia infections for patients suspected of having early Lyme disease. Run on the fully automated FDA-cleared T2Dx® Instrument, the T2Lyme Panel is designed to detect Lyme disease-causing bacteria in 3 to 5 hours.
The data from a 2017 pre-clinical study evaluated 21 patients enrolled with an erythema migrans (EM) rash with suspected early Lyme disease and assessed with multiple Lyme diagnostics. The study compares various diagnostic methods with the T2Lyme Panel, in determining a definitive Borrelia infection, using tissue biopsy culture from the EM rash. Of all the diagnostics tested, the T2Lyme Panel blood test was the most accurate compared to tissue culture with a 78% positive percent agreement (PPA) and 100% negative percent agreement (NPA). Two-tier serology, the currently recommended diagnostic, had a 56% PPA and 92% NPA compared to tissue culture, while blood polymerase chain reaction (PCR) did not correctly identify any positives. Eight (38%) patients were negative for all diagnostics. The 100% NPA of the T2Lyme Panel indicates greater specificity over serology resulting in less incidence of false positive results. Overall, the T2Lyme Panel has been evaluated against 558 negative samples with no false-positive results.
“We are excited that the pre-clinical data is promising as the T2Lyme Panel performed better than all other diagnostics tested and suggests the panel can improve upon existing Lyme diagnostic tests,” said Dr. Nitin Damle, co-author of the study and Clinical Associate Professor of Medicine, Alpert Medical School at Brown University. “The strong specificity suggests clinicians can have a high degree of confidence that a T2Lyme positive is a true infection.”
The data in the poster was co-authored by clinicians and experts from Marshfield Clinic Research Institute, Massachusetts General Hospital, and South County Internal Medicine in Wakefield, Rhode Island, and presented at the 15th International Conference on Lyme Borreliosis and Other Tick-Borne Diseases (ICLB), hosted by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the National Environmental Health Association (NEHA).
About Lyme Disease & Current Diagnostics
Lyme disease is caused by Borrelia bacteria that is transmitted to humans through the bite of infected ticks. The symptoms patients commonly see are fever, headache, fatigue, and a skin rash called erythema migrans (EM). The infection an spread to joints, the heart, and the nervous system if left untreated.
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. Additionally, because antibodies can exist due to prior infections, serology’s specificity is limited.
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 annually according to research from the CDC.
About the T2Lyme Panel
The T2Lyme Panel, which is designed for use with the fully automated T2Dx Instrument, provides diagnostic results in hours and has high analytical sensitivity and specificity, identifying Borrelia burgdorferi, Borrelia afzelii and Borrelia garinii at levels as low as 3 cells/mL in whole blood, potentially making it a valuable diagnostic tool in detecting early-stage Lyme disease. B. burgdorferi is the predominant species in a North America, and B. afzelii and B. garinii are most prevalent in Asia and Europe. The T2Lyme Panel is more sensitive to the detection of early-stage Lyme than antibody-based tests where subjects may not have developed detectable antibodies, yielding less false negative results. The T2Lyme Panel is also able to identify other Borrelia species that are responsible for other tick-borne diseases such as relapsing fever.
T2 Biosystems is currently enrolling patients in a pivotal clinical trial of the T2Lyme Panel. The Company anticipates completing the pivotal trial in 2019.
About T2 Biosystems:
T2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx Instrument, T2Candida® Panel, and T2Bacteria® Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease. For more information, please visit www.t2biosystems.com.
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, including, without limitation, statements regarding additional patients, timing of testing patients, anticipated product benefits, strategic priorities, product expansion or opportunities, growth expectations or targets, timing of FDA filings or clearances and anticipated operating expenses, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. 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, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission, or SEC, on March 19, 2018, and other filings the company makes with the SEC from time to time. 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. 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, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. 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.
Gina Kent, Vault Communications
Matthew Clawson, W2O Group
Source link http://www.tmcnet.com/usubmit/2018/09/26/8824204.htm