T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products 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 platform, 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 unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum and urine, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter, or CFU/mL. Our initial development efforts utilizing T2MR target sepsis, hemostasis and Lyme disease, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics.
On September 22, 2014, the U.S. Food and Drug Administration, or the FDA, authorized us to market the T2Dx Instrument and T2Candida Panel. These are the first FDA-cleared products that enable species-specific detection of sepsis pathogens in 3 to 5 hours without the need for blood culture, which typically takes 2 to 6 days. We are currently developing our next three diagnostic applications, the T2Bacteria Panel, T2HemoStat Panel, and T2Lyme Panel, which are focused on bacterial sepsis infections, hemostasis, and Lyme disease, respectively.