Manage Tickers Link Financial Account

Has my stock been accused of fraud?Join over 160k users who know.

Ticker	Price	Change($)	Change(%)	Shares	Volume	Prev Close	Open	Gain($)	Gain(%)

Ticker	Status	Jurisdiction	Filing Date	CP Start	CP End	CP Loss	Deadline

Ticker	Case Name	Status	CP Start	CP End	Deadline	Settlement Amt

Ticker	Name	Date	Analyst Firm	Up/Down	Target ($)	Rating Change	Rating Current

T2 Biosystems Provides Updates On New Product Development Pipeline Progress

Author: Benzinga Newsdesk | September 09, 2024 09:10am

Finalizing a 510(k) premarket notification application for the T2Resistance® Panel planned to be filed with the U.S. Food and Drug Administration (FDA) during the fourth quarter of 2024.
The previously submitted 510(k) premarket notification to expand use of the T2Candida® Panel to detect pediatric Candida infections is pending clearance with the FDA.
Advanced internal validation and plans to submit a 510(k) premarket notification to the FDA to expand the use of its FDA-cleared T2Bacteria® Panel to detect pediatric bacterial infections.
The Company maintains its plan to launch the T2Lyme™ Panel as a Laboratory Developed Test (LDT); however, it now plans to build or buy its own laboratory rather than launch through a partnership.
- Pursuing non-dilutive funding to complete the development, validation, and clinical studies for a diagnostic test to detect Candida auris, following the completion of feasibility and early development in collaboration with the U.S. Centers for Disease Control and Prevention (CDC).

Posted In: TTOO