T2 Biosystems Gets 510(k) Clearance For Expanded T2Bacteria Panel
By Chris Wack
T2 Biosystems has received 510(k) clearance from the U.S. Food and Drug Administration for the expanded T2Bacteria Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii, to the expansive panel.
The company said A. baumannii is a cause of bloodstream infections, especially in critically ill patients, which can range from benign transient bacteremia to septic shock.
T2 said the addition of A. baumannii represents hitting another regulatory milestone and increases the value proposition of the T2Bacteria Panel by covering 75% of all sepsis-causing bacterial pathogens commonly found in blood stream infections.
The company said the T2Bacteria Panel is the first and only FDA-cleared product able to detect sepsis-causing pathogens directly in whole blood, in three to five hours, without the need to wait days for a positive blood culture.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
February 12, 2024 09:28 ET (14:28 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
For Bond Investors, Delayed Rate Cuts Demand a Different Playbook
-
What’s Happening In the Markets This Week
-
How the Tokyo Stock Exchange Is Pushing for Better Shareholder Returns
-
Magnificent 7 Stocks Earnings Updates: AI Remains the Focus
-
Where We See Opportunities After an Ugly Month for Stocks
-
After Earnings, Is Alphabet Stock a Buy, a Sell, or Fairly Valued?
-
When Will the Fed Start Cutting Interest Rates?
-
What’s the Difference Between the CPI and PCE Indexes?
-
Berkshire Hathaway Earnings: Strong Insurance Results Continue to Lift Revenue and Profitability
-
10 Questions for Berkshire Hathaway’s 2024 Annual Meeting
-
After Earnings, Is Ford Stock a Buy, a Sell, or Fairly Valued?
-
3 Dividend Stocks for May 2024
-
Amgen Earnings: Obesity Drug Update Is Highly Encouraging
-
What’s Going on With Apple, Tesla, and Alphabet?
-
Apple Earnings: A Weak 2024, but Optimism for 2025
-
4 Utility Stocks to Play the AI Data Center Boom