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FDA clears T2 Biosystems for expanded sepsis panel

by WorldFinance
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FDA clears T2 Biosystems for expanded sepsis panel
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LEXINGTON, Mass. – T2 Biosystems, Inc. (NASDAQ:), a company specializing in the detection of sepsis-causing pathogens, has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for an update to its T2Bacteria Panel. The panel now includes the detection of Acinetobacter baumannii (A. baumannii), a bacterium known to cause serious bloodstream infections, particularly in critically ill patients. This addition is expected to enhance the panel’s capability to cover approximately 75% of all bacterial pathogens found in bloodstream infections leading to sepsis.

A. baumannii is recognized for its high mortality rate in intensive care units, with a crude ICU mortality rate reported between 34.0% and 43.4%. The pathogen is commonly associated with hospital-acquired infections, particularly in patients with prolonged hospital stays or those with open wounds or catheters. The World Health Organization has identified A. baumannii as a critical bacterium needing improved prevention and treatment due to its resistance to multiple antibiotics, including carbapenems, which can hike mortality rates up to 70%.

John Sperzel, Chairman and CEO of T2 Biosystems, expressed his enthusiasm about the FDA clearance, anticipating that it will lead to broader adoption of the company’s direct-from-blood platform. The expanded T2Bacteria Panel is part of T2 Biosystems’ product line, which includes the T2Dx Instrument, T2Candida Panel, T2Resistance Panel, and T2Biothreat Panel, all based on the proprietary T2 Magnetic Resonance (T2MR) technology.

The information in this article is based on a press release.

InvestingPro Insights

T2 Biosystems, Inc. (NASDAQ:TTOO) has recently achieved a significant milestone with the FDA clearance for an update to its T2Bacteria Panel. While this development bodes well for the company’s product offerings and potential impact on healthcare, a closer look at the company’s financial health through InvestingPro data provides a broader perspective on its operational status.

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InvestingPro Data indicates a market capitalization of approximately $22.48 million USD, reflecting the size of the company within the biotechnology sector. The revenue for the last twelve months as of Q3 2023 stands at $11.0 million USD, but it’s important to note a substantial revenue decline of -53.8% during the same period. This decline is echoed in the quarterly revenue growth, which plummeted by -59.97% in Q3 2023. These figures suggest that while T2 Biosystems may be innovating in the medical field, it is currently facing significant financial headwinds.

From the InvestingPro Tips, the company is identified as operating with a significant debt burden and quickly burning through cash. Additionally, analysts anticipate a sales decline in the current year, which could further strain the company’s financial resources. With gross profit margins suffering, as indicated by a -283.22% gross profit margin in the last twelve months as of Q3 2023, the company’s ability to turn innovation into financial stability may be challenged in the short term.

Despite these challenges, T2 Biosystems has seen a strong return over the last week and month, with price total returns of 13.19% and 17.55% respectively. This suggests that investors may be responding positively to the recent FDA clearance and potential future growth. However, it’s crucial for potential investors to consider the company’s overall financial health and the broader market conditions.

For those interested in a deeper analysis, InvestingPro offers a wealth of additional tips for T2 Biosystems, providing further insights into the company’s performance and potential. With a total of 15 additional InvestingPro Tips available, subscribers can gain a comprehensive understanding of the company’s financial nuances. To explore these insights, visit https://www.investing.com/pro/TTOO and remember to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

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This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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