T2 Biosystems files 510(k) for T2Bacteria Panel

T2 Biosystems Inc. (NSDQ:TTOO) said today it filed a 510(k) appliation with the FDA for its T2Bateria Panel rapid diagnostic solution designed to identify pathogens assocaited with Sepsis.

The T2Bacteria panel is designed to run on the FDA-cleared T2Dx instrument to provide diagnosis of sepsis pathogens within hours, reducing the time for patients with bloodstream infections to receive treatment, the Lexington, Mass.-based company said.

The submission includes data from a pivotal clinical trial of the T2Bacteria Panel which compared it to blood culture, as well as the performance of the panel in known bacteria positive samples, the company said. Results from the trials indicated a 95.8% average sensitivity and 98.1% average specificity.

“Bacterial infections are a major cause of poor health outcomes and a driver of costs in hospitals today. There is a great need for improved diagnostics to aid clinicians in providing faster treatment and the T2Bacteria Panel is the first product submitted for FDA clearance that detects bacteria species directly from whole blood, providing faster, actionable information,” Dr. Mitchell Cohen of the University of Colorado said in a prepared statement.

The T2Bacteria Panel is designed to identify the human blood specimens Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus, T2 said.

“The filing of T2Bacteria brings us one step closer to achieving our goal of providing the healthcare system with a comprehensive sepsis solution. We are very pleased with the performance of the T2Bacteria Panel in the pivotal clinical trial as the product has demonstrated performance comparable to our FDA-cleared T2Candida Panel. We have already seen significant interest from hospitals in using the product under a Research Use Only program that we offered on a limited basis this past spring,” prez & CEO John McDonough said in preapred remarks.

Last week, T2 Biosystems said that the US Centers for Disease Control and Prevention will use its T2Dx Instrument to test and monitor for the emergence and outbreaks of the antibiotic-resistant superbug Candida auris.

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