FDA Events for T2 Biosystems (TTOO)
This section highlights FDA-related milestones and regulatory updates for drugs developed by T2 Biosystems (TTOO).
Over the past two years, T2 Biosystems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
T2Candida. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
T2Candida Panel - FDA Regulatory Timeline and Events
T2Candida Panel is a drug developed by T2 Biosystems for the following indication: Direct-from-blood fungal pathogen detection assay.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- T2Candida Panel
- Announced Date:
- September 16, 2024
- Indication:
- Direct-from-blood fungal pathogen detection assay
Announcement
T2 Biosystems, Inc announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its FDA-cleared T2Candida® Panel for pediatric patients.
AI Summary
T2 Biosystems, Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) to market its T2Candida® Panel for pediatric patients. This clearance expands the availability of the test, which is currently the only FDA-cleared diagnostic that can directly detect sepsis-causing Candida species from blood samples in just 3-5 hours—a significant improvement over traditional blood culture methods that take days for results.
The panel, which runs on the FDA-cleared T2Dx® Instrument, detects five Candida species that account for up to 95% of bloodstream infections in the U.S. By enabling faster species identification, the test is expected to improve clinical outcomes by allowing quicker, targeted antifungal treatment. T2 Biosystems plans to begin marketing the panel immediately to over 200 children’s hospitals across the country.
Read Announcement
T2 Biosystems FDA Events - Frequently Asked Questions
As of now, T2 Biosystems (TTOO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, T2 Biosystems (TTOO) has reported FDA regulatory activity for T2Candida Panel.
The most recent FDA-related event for T2 Biosystems occurred on September 16, 2024, involving T2Candida Panel. The update was categorized as "FDA Clearance," with the company reporting: "T2 Biosystems, Inc announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its FDA-cleared T2Candida® Panel for pediatric patients."
Currently, T2 Biosystems has one therapy (T2Candida Panel) targeting the following condition: Direct-from-blood fungal pathogen detection assay.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:TTOO) was last updated on 7/10/2025 by MarketBeat.com Staff
