T2 BIOSYSTEMS, INC. (NASDAQ:TTOO) Files An 8-K Other EventsItem 8.01. Other Events.
On May29, 2018, T2 Biosystems,Inc. issued a press release announcing that it received market clearance from the U.S. Food and Drug Administration (FDA) for the T2Bacteria® Panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections. The T2Bacteria Panel runs on the T2Dx® Instrument. The FDA-cleared T2Bacteria Panel identifies five of the most common and deadly sepsis-causing species of bacteria: Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
A copy of the press release announcing the approval is attached as Exhibit99.1 to this Current Report on Form8-K and is incorporated by reference herein.
Item 8.01 Financial Statements and Exhibits
|99.1||Press Release issued May29, 2018|
T2 Biosystems, Inc. ExhibitEX-99.1 2 d585909dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 T2 Biosystems Receives FDA Clearance to Market T2Bacteria Panel for Detection of Sepsis-Causing Pathogens First FDA-cleared test to identify sepsis-causing bacteria direct from whole blood Cuts time to diagnosis from days to hours,…To view the full exhibit click
About T2 BIOSYSTEMS, INC. (NASDAQ:TTOO)
T2 Biosystems, Inc. is an in vitro diagnostics company engaged in developing a technology platform offering an alternative to diagnostic methodologies. The Company’s T2 Magnetic Resonance platform (T2MR) enables detection of pathogens, biomarkers and other abnormalities in a range of unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum and urine, and can detect cellular targets at limits of detection as one colony forming unit per milliliter (CFU/mL). The Company’s initial development efforts target sepsis, hemostasis and Lyme disease. T2MR is a miniaturized, magnetic resonance-based approach that measures how water molecules react in the presence of magnetic fields. Its platform detects a range of targets, including molecular targets, such as deoxyribonucleic acid (DNA), immunodiagnostics, such as proteins, and a range of hemostasis measurements. The Company offers T2Dx Instrument (T2Dx) and the T2Candida Panel.