T2 BIOSYSTEMS,INC. (NASDAQ:TTOO) Files An 8-K Other Events

ME Staff 8-k
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T2 BIOSYSTEMS,INC. (NASDAQ:TTOO) Files An 8-K Other Events
Item 9.01 Other Events

On August 4, 2017, T2 Biosystems,Inc. (the “Company”) completed a pivotal clinical study of the T2Bacteria® Panel, run on the T2Dx® Instrument, which is a qualitative T2 Magnetic Resonance assay designed for the direct detection of bacterial species in human whole blood specimens from patients with suspected bacteremia. The performance characteristics of the T2Bacteria® Panel were evaluated through a series of analytical studies as well as a multi-center clinical study. The clinical trial evaluated the performance of the T2Bacteria® Panel in comparison to the current standard of care, blood culture. The data generated in the analytical and clinical studies were submitted to the United States Food and Drug Administration in a 510(k) application on September8, 2017.

The Company is filing as Exhibit99.1 to this Current Report on Form8-K additional information concerning data generated in the pivotal clinical trial for theT2Bacteria® Panel, which is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

ExhibitNo.

Description

99.1

T2Bacteria® Panel Pivotal Clinical Study Information


T2 Biosystems, Inc. Exhibit
EX-99.1 2 a17-21555_1ex99d1.htm EX-99.1 Exhibit 99.1   T2Bacteria® Panel Pivotal Clinical Study Information   On August 4,…
To view the full exhibit click here

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.