LEXINGTON, Mass. - T2 Biosystems, Inc. (NASDAQ:TTOO), a company specializing in the detection of sepsis-causing pathogens and antibiotic-resistance genes, announced findings from a European study published in The Journal of Clinical Microbiology. The study evaluated the T2Resistance Panel's clinical utility in a real-world hospital setting, showing high accuracy rates and faster detection times that could influence clinical interventions.
The two-center prospective trial included 59 patients and aimed to assess the clinical sensitivity and performance of the T2Resistance Panel compared to standard blood culture and microbiological methods. The panel, which detects 13 antibiotic resistance genes directly from blood, showed a 94.7% clinical sensitivity and 97.4% specificity. Notably, results were obtained in 4.4 hours on average, a significant reduction from the 58.3 hours typically required with blood culture-based methods.
This rapid turnaround time led to 49 clinical interventions across the patient group, which included 17 antibiotic escalations and 32 discontinuations of unnecessary antibiotics. The study's authors concluded that the T2Resistance markers were highly sensitive for detecting drug resistance genes in patients with bacterial bloodstream infections, providing resistance detection approximately 90% faster than standard methods and influencing antimicrobial therapy decisions.
The T2Resistance Panel operates on the FDA-cleared T2Dx Instrument and is available in Europe under a CE mark. It has been granted Breakthrough Device designation by the FDA, indicating priority review for the U.S. market. T2 Biosystems plans to submit a 510(k) premarket notification to the FDA later this year.
John Sperzel, Chairman and CEO of T2 Biosystems, expressed optimism that the growing dataset from the study would encourage wider adoption of the panel in CE Mark-accepting countries and serve as a precursor to the company's U.S. market launch.
T2 Biosystems' portfolio includes various panels and instruments based on its proprietary T2 Magnetic Resonance technology, with an active pipeline of future products.
The information in this article is based on a press release.
InvestingPro Insights
While T2 Biosystems (NASDAQ:TTOO) has been making strides in the medical diagnostics field with its T2Resistance Panel, the financial health of the company raises concerns for investors. According to InvestingPro data, T2 Biosystems has a market capitalization of 20.62 million USD, reflecting the market's current valuation of the company. However, the company's financial metrics indicate some challenges. The revenue for the last twelve months as of Q3 2023 stood at 11.0 million USD, which represents a significant decline of 53.8% compared to the previous period. This downturn is mirrored in the company's gross profit margin, which was reported at -283.22%, suggesting that the cost of goods sold far exceeds the revenue generated—a situation that is unsustainable in the long term.
Investors should note that the company's P/E ratio is negative, standing at -0.44, which typically indicates that the company is not currently profitable. Furthermore, the price of T2 Biosystems' stock has experienced a notable decline, with a one-year price total return of -91.56% as of the latest available data. This performance highlights the market's reaction to the company's financial health and future prospects.
Among the InvestingPro Tips for T2 Biosystems, it's worth mentioning that analysts do not anticipate the company will be profitable this year, and the stock has fared poorly over the last month. These insights might be particularly relevant for potential investors considering the company's future revenue and profitability outlook.
For those interested in a deeper analysis, there are additional InvestingPro Tips available that shed light on the company's financial situation and market performance. For instance, T2 Biosystems operates with a significant debt burden and is quickly burning through cash, which could affect its ability to finance operations without seeking additional capital. To explore these insights further, readers can visit InvestingPro and use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking access to a total of 14 tips that provide a comprehensive view of the company's financial health and market standing.
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