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T2 Biosystems Receives 510(K) Clearance for Its Bacteria Panel


  • The U.S. Food and Drug Administration (FDA) has provided T2 Biosystems (TTOO) with 510(k) clearance for Acinetobacter baumanniiin its expanded T2Bacteria Panel.
  • The bacteria carries a crude ICU mortality rate between 34% and 43.4%.
  • With today’s rise, TTOO stock is now positive on a year-to-date basis.
TTOO stock - T2 Biosystems Receives 510(K) Clearance for Its Bacteria Panel

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Shares of T2 Biosystems (NASDAQ:TTOO) are jumping higher by more than 30%. This comes as the diagnostics company announced that it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for Acinetobacter baumannii (A. baumannii) capability detection in its expanded T2Bacteria Panel. The bacteria is the 10th-most-common pathogen with a crude intensive care unit (ICU) mortality rate between 34% and 43.4%.

Commenting on the news, chairman and CEO John Sperzel said:

“The addition of A. baumannii represents the achievement of another successful product development and regulatory milestone for T2 Biosystems and increases the value proposition of the T2Bacteria Panel by covering approximately 75% of all sepsis-causing bacterial pathogens commonly found in blood stream infections.”

TTOO Stock: T2 Receives Expanded T2Bacteria Panel 510(k) Clearance

The World Health Organization (WHO) has classified A. baumannii as the “most critically important bacteria that requires improved prevention and therapeutic approaches.” This is due to its tendency to be pan-antibiotic resistant. Additionally, carbapenem-resistant A. baumannii pose problems as well and can carry a mortality rate as high as 70%.

T2 notes that its T2Bacteria Panel is the first and only FDA-approved product that can detect sepsis-causing pathogens directly in whole blood and can do so in just three to five hours. The panel now has FDA approval to detect E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, E. coli and A. baumannii.

The announcement comes as welcome news to shareholders and has propelled TTOO stock’s year-to-date return to positive territory. However, TTOO is still down by about 95% year-over-year (YOY).

Meanwhile, T2 has a major catalyst on the horizon. It will report its fourth-quarter and 2023 full-year results on Thursday, Feb. 15, after the market close. Analysts tracked by Koyfin expect the company to report $2 million of revenue, signaling a YOY decline of 56.23%. Furthermore, T2 will likely stay unprofitable with a GAAP earnings per share (EPS) loss of $2.22. Analyst estimates until the fourth quarter of 2024 expect the company to remain unprofitable throughout every single quarter.

For the full year of 2023, revenue is expected to fall by 64.58% to $8 million. The GAAP EPS loss projection is $18.57.

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On the date of publication, Eddie Pan did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.  

Eddie Pan specializes in institutional investments and insider activity. He writes for InvestorPlace’s Today’s Market team, which centers on the latest news involving popular stocks.

Article printed from InvestorPlace Media, https://investorplace.com/2024/02/t2-biosystems-receives-510k-clearance-for-its-bacteria-panel/.

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