T2 Biosystems Aims to Revolutionize Bioterrorism Detection with Latest FDA 510(k) Submission

T2 Biosystems Inc. (NASDAQ:TTOO) has skyrocketed to the forefront of early detection of dangerous sepsis-causing pathogens and antibiotic resistance genes with their newly submitted T2Biothreat™ Panel to the FDA. Having conducted extensive clinical trials with 350 positive sample blood tests and 470 negative blood tests from healthy and unwell individuals alike, the T2Biothreat™

Panel is science-backed to be extremely precise and reliable. With this new revolutionary way of detecting sepsis-causing pathogens and antibiotic resistance, T2 Biosystems Inc. is poised to be highly successful in the industry.

The T2Biothreat Panel offers timely and precise detection of some of the most dangerous threats to health, from anthrax (Bacillus anthracis) to plague (Yersinia pestis). It’s fully automated, direct-from-blood test, run on FDA-cleared T2Dx® Instrument, that can quickly identify six of the most concerning biothreats identified by Centers for Disease Control and Prevention. Getting accurate results offers a critical chance to provide the right treatment as quickly as possible. Protect yourself and those you love from these insidious foes with the T2Biothreat Panel.

T2 Biosystems has achieved a significant milestone with the submission of its T2Biothreat Panel to the FDA, furthering the company’s mission to protect Americans from biothreats, be they natural or intentional.

The advanced technology of this direct-from-blood multi-target biothreat product has achieved high levels of sensitivity and specificity, making it the only such product of its kind developed by a United States-based company. T2 Biosystems looks forward to continuing the FDA premarket review process, with the aim of obtaining clearance and making its life-saving product available in the United States.

In a public health emergency involving biothreat pathogens, time is of the essence. Left untreated, these infections can cause mortality rates of up to 90%. Fortunately, with the T2Biothreat Panel, clinicians can quickly detect biothreat pathogens in just 4 hours, giving them the information they need to treat patients effectively and reduce the risk of mortality. By using rapid and accurate diagnostic testing, the health and economic effects of the biothreat can be minimized.

This project has been generously supported by the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), through contract number 75A50119C00053. We are thankful for this investment in the health and wellbeing of our community!

About T2 Biosystems

T2 Biosystems is revolutionizing the world of patient care with their state-of-the-art, rapid detection products. By utilizing their proprietary T2 Magnetic Resonance (T2MR®) technology, their products – including the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel and the T2SARS-CoV-2™ Panel – help clinicians diagnose and treat patients with sepsis-causing pathogens, antibiotic resistance genes, and more, faster and more effectively than ever before.

To top it off, they have an active pipeline of upcoming products, such as the the T2Biothreat™ Panel, the T2Cauris™ Panel, and T2Lyme™ Panel. This revolutionary technology is driving down healthcare costs and saving countless lives around the world.

Forward-Looking Statements

The T2Biothreat Panel offers the possibility of revolutionizing security from biothreats – both deliberate and naturally occurring. With the capability to detect and analyze six biothreat pathogens simultaneously, it could potentially help protect Americans from the dangerous risks of such pathogens. That said, the future of this product remains uncertain – demand levels, FDA clearances, operating expenses, and other factors may all affect outcomes. The Company is committed to providing transparency into its development process, and is dedicated to supporting the mission of protecting Americans from biothreats.

Leave a Comment