T2 Biosystems Receives CE Mark for T2Bacteria™ Panel Enabling Commercialization In Europe
New Diagnostic Test Panel Expands Platform Menu Providing Comprehensive T2Sepsis Solution™ for Hospitals
LEXINGTON, Mass., July 18, 2017 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, announced today that it has received a CE Mark for its T2Bacteria Panel, allowing for the sale and distribution of the product within the European Union and those countries accepting the CE Mark. The T2Bacteria Panel runs on the Company’s proprietary T2Dx® Instrument and provides highly accurate species-specific test results of targeted bacterial infections direct from whole blood in as fast as about 3.5 hours, and without the need for a time-consuming blood culture. The T2Bacteria Panel is currently available in the United States for Research Use Only (RUO) and the Company is in the final stages of completing the FDA pivotal trial, after which a 510(k) application will be submitted to the FDA. Patient enrollment in the trial is currently 92% complete and the company is very pleased with the product performance demonstrated to date, which for the prospective arm of the study is showing an average sensitivity of 96% and average specificity of 98%.
The T2Candida® Panel and the T2Dx Instrument were both CE-marked and FDA-cleared in 2014 and now, combined with the new T2Bacteria Panel, provide a comprehensive sepsis solution for hospitals in Europe. Consistent with previous guidance, the company believes it is on track to potentially receive FDA clearance of the T2Bacteria Panel by the end of 2017 enabling a US commercial launch in early 2018. Once the clinical trial is complete, the company will provide a full update on the product performance metrics submitted to the FDA.
“The CE Mark of our T2Bacteria Panel is a significant milestone in our mission to save lives and improve healthcare by empowering clinicians to more effectively treat patients with sepsis faster than ever before,” said John McDonough, president and chief executive officer. “Our T2Sepsis Solution now includes T2Candida and T2Bacteria, creating a significant opportunity to expand our target hospitals and positioning T2 Biosystems for accelerated commercial growth.”
CE Mark confirms that the product meets the Essential Requirements of the European Directive on In Vitro Diagnostic Medical Devices. The T2Bacteria Panel will be commercially available as part of the T2Sepsis Solution in Europe in the third quarter 2017.
The T2Bacteria Panel identifies six of the most deadly and prevalent bacteria species that are often not covered by empiric therapy. The prevalence of bacterial infections is high in hospitals across the world and the T2Bacteria Panel identifies approximately 90% of all gram-negative infections coming in through the emergency department and approximately 70% of community-acquired infections in the emergency department. Current broad spectrum antimicrobial therapy regimens only cover 60% of all bloodstream infections. Test results generated from the T2Candida Panel and T2Bacteria Panel, when coupled with current empiric therapy practices, may empower healthcare teams to effectively treat up to 95% of all bloodstream infections presenting in hospitals within the first 4 hours.
Additionally, the company is seeing significant interest from new and existing customers in working with the T2Bacteria RUO Panel under a Research Use Only program where customers can begin early validation testing to accelerate adoption post FDA clearance.
“We are pleased to be close to finalizing the submission of our T2Bacteria Panel to the FDA,” said Tom Lowery, chief scientific officer. “Even more encouraging are the early responses we have been receiving from hospitals taking advantage of the T2Bacteria Panel under the RUO program. We believe the RUO program will provide independent data for hospitals to present at conferences and for publications later this year and into 2018.”
T2 Biosystems will provide an additional, more comprehensive update on its upcoming second quarter 2017 financial update call and at this time is reiterating its prior financial guidance.
About T2 Biosystems
T2 Biosystems is dedicated to developing innovative diagnostic products to improve patient health. With the FDA-cleared T2Dx Instrument and T2Candida Panel targeting sepsis 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 T2 Magnetic Resonance technology, or T2MR®, 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.
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.