NEW YORK (GenomeWeb) – T2 Biosystems said today that it has received CE marking for its T2Bacteria Panel, enabling the sale and distribution of the product within the European Union countries and others accepting the mark.
The bacteria panel will be commercially available as part of the T2Sepsis Solution in Europe in the third quarter of 2017, the firm said.
In the US, the panel is available as a research-use-only assay, but T2 said that it is in the "final stages of completing" a US Food and Drug Administration pivotal trial, after which it will apply for 510(k) clearance that would enable it to sell and distribute the panel in the US.
The firm noted that it has enrolled 92 percent of the patients needed to complete the trial for US clearance. To date, in the prospective arm of the study, the assay is showing an average sensitivity of 96 percent and average specificity of 98 percent, T2 said.
The firm noted that consistent with previous guidance, it believes it is on track "to potentially receive FDA clearance of the T2Bacteria Panel by the end of 2017, enabling a US commercial launch in early 2018."
The T2Bacteria Panel runs on the firm's proprietary T2Dx instrument and provides species-specific test results for targeted bacterial infections direct from whole blood in about 3.5 hours, without the need for a time-consuming blood culture.
The panel identifies six of the most deadly and prevalent bacteria species that are often not covered by empiric therapy, the firm said. It identifies about 90 percent of all gram-negative infections coming in through the emergency department, and about 70 percent of community-acquired infections in the emergency department, the firm said, adding that current broad spectrum antimicrobial therapy regimens cover 60 percent of all bloodstream infections.
The company's T2Dx Instrument and T2Candida Panel were both CE-marked and FDA-cleared in 2014.
T2's President and CEO John McDonough said in a statement that the firm's T2Sepsis Solution now includes the T2Candida and T2Bacteria panels, and that this creates "a significant opportunity to expand our target hospitals" and positions the firm for "accelerated commercial growth."