NEW YORK – T2 Biosystems announced on Monday that it has received 510(k) clearance from the US Food and Drug Administration for an extended version of its T2Bacteria syndromic panel.
The T2Bacteria Panel detects pathogens that cause bloodstream infections directly from whole-blood samples within three to five hours using a combination of magnetic resonance technology and PCR performed on the firm's T2Dx instrument.
T2Bacteria received the CE mark in 2017, and was cleared by the FDA in 2019 to detect five common sepsis-causing pathogens: Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
The extended version announced on Monday now adds a sixth target: Acinetobacter baumannii.
"We are thrilled to receive the FDA 510(k) clearance for the expanded T2Bacteria Panel, to include the detection of A. baumannii, as we believe it will lead to increased adoption of our proprietary direct-from-blood platform," John Sperzel, chairman and CEO of T2 Biosystems, said in a statement.
Considered a healthcare-acquired infection, A. baumannii caused an estimated 8,500 infections in hospitalized patients and 700 deaths in the US in 2017, according to the Centers for Disease Control and Prevention. Pan-antibiotic resistant A. baumannii has also been classified as a "priority pathogen" by the World Health Organization due to rising resistance rates.
T2 Bio is also readying its T2Resistance Panel for submission to the FDA. As previously reported, the firm's T2Resistance Panel won $2 million in support from CARB-X and obtained the CE mark for a test that detects 13 genes conferring antimicrobial resistance using its T2Dx instrument. The T2Resistance Panel has also been supported by up to $62 million from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority.
In May 2023, the firm announced it would lay off 30 percent of its workforce after revenues declined 70 percent. Its T2Biothreat Panel was cleared by the FDA in September, but the company was threatened with delisting by the Nasdaq in November.
Shares of T2 Bio were up 15 percent to $5.61 in Monday morning trading on the Nasdaq.