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LEXINGTON, Mass. - T2 Biosystems, Inc. (NASDAQ:TTOO), has announced the FDA clearance of its T2Candida Panel for use in pediatric patients. The diagnostic test, which detects sepsis-causing Candida species directly from blood samples, can now be marketed and sold to children's hospitals across the United States. The T2Candida Panel is recognized for its rapid results, providing detection within 3-5 hours, a significant improvement over traditional blood culture methods that may take days.
The T2Candida Panel operates on the T2Dx Instrument and identifies five Candida species responsible for up to 95% of Candida bloodstream infections in the U.S., according to the CDC. The inclusion of pediatric testing expands the test's clinical utility and is expected to enable better patient outcomes and reduced healthcare costs by facilitating faster targeted antifungal treatment for children.
Studies have underscored the test's efficiency, with one showing that the T2Candida Panel delivers species identification results 121.8 hours faster than blood culture, with a higher detection rate. Another study highlighted the panel's superior sensitivity and specificity compared to other pre-blood culture tests, recommending its use for diagnosing invasive candidiasis in at-risk children and adolescents.
The burden of invasive candidiasis in hospitalized children is substantial, with a mean increased hospital stay of 21 days and excess costs of approximately $92,000, further emphasizing the need for prompt and accurate diagnostic tools like the T2Candida Panel.
John Sperzel, Chairman and CEO of T2 Biosystems, expressed the company's commitment to improving sepsis testing and the immediate start of marketing efforts to over 200 children's hospitals in the U.S. He highlighted the panel's potential to significantly speed up detection and enhance sensitivity compared to blood culture-based diagnostics.
T2 Biosystems is known for its rapid detection technology for sepsis-causing pathogens and antibiotic resistance genes, aiming to improve patient care and reduce the cost of care. The T2Candida Panel joins the company's suite of products, including the T2Bacteria Panel, T2Resistance Panel, and T2Biothreat Panel, with an active pipeline for future products.
The information provided is based on a press release statement from T2 Biosystems.
In other recent news, T2 Biosystems, a company focused on the rapid detection of sepsis-causing pathogens, reported record quarterly and first-half sepsis test revenue during their second quarter 2024 earnings call. Despite a net loss of $9.2 million, the company announced robust revenue growth projections for sepsis products and revealed ongoing negotiations with a potential US commercial partner to enhance operations. The firm also highlighted its upcoming T2Lyme Panel launch and advancements in its product pipeline, including the T2Resistance Panel and the expanded T2Candida Panel, all of which have received FDA breakthrough device designation.
In financial updates, the company reported second-quarter revenues of $2 million and projected growth in sepsis product revenues to $10 million to $11 million in 2024. The firm is also reducing its US sales force in anticipation of a commercial partnership and implementing an ATM to strengthen its balance sheet. The company expects mid-40% to mid-50% year-over-year growth in product revenue and plans to submit the T2Resistance to the FDA for 510(k) clearance in Q4 2024. These recent developments highlight T2 Biosystems' strategic initiatives for growth in the sepsis diagnostics market.
InvestingPro Insights
As T2 Biosystems (NASDAQ:TTOO) garners attention with the FDA clearance of its T2Candida Panel for pediatric use, investors are closely monitoring the company's financial health and stock performance. The latest metrics from InvestingPro paint a detailed picture of the company's current market position.
InvestingPro Data reveals a market capitalization of $44.22 million, indicating the company's size and market value. Despite the innovative steps T2 Biosystems is taking in the medical diagnostics field, the company's revenue for the last twelve months as of Q2 2024 stands at $7.16 million, reflecting a substantial decline of 45.74%. This contraction in revenue signals challenges in the company's commercial operations.
The financial data also shows that T2 Biosystems has a negative price-to-earnings (P/E) ratio of -0.38, which is further adjusted to -0.96 for the last twelve months as of Q2 2024. This negative P/E ratio suggests that the company is not currently generating profits, a concern that is echoed by one of the InvestingPro Tips. The company is noted to be not profitable over the last twelve months, emphasizing the need for a strategic approach to reach profitability.
InvestingPro Tips also highlight that T2 Biosystems is quickly burning through cash and suffers from weak gross profit margins, which could impact its ability to sustain operations without additional financing. Moreover, the company's stock has experienced a significant price decline over the last year, which may be a point of consideration for potential investors.
For those interested in a deeper analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/TTOO. These tips provide further insights into the company's financial status and stock performance, offering valuable information for making informed investment decisions.
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