LEXINGTON, Mass., Dec. 18, 2024 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ: TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced the sale of four T2Dx Instruments to its European distributor that represents multiple EU counties, demonstrating commercial expansion and increased international market penetration.
The multiple instrument sale demonstrates commercial expansion to enable increased utilization of the T2Bacteria® Panel, the T2Candida® Panel, and the T2Resistance® Panel. The target hospitals for the new instruments include:
- Selling a second T2Dx Instrument to a major reference hospital to expand “same store” sales;
- Selling the first T2Dx Instrument to a hospital in a country for initial market penetration; and
- Selling two T2Dx Instruments to hospitals in countries that already utilize T2 Biosystems’ products.
“Our international distributors continue to expand the global footprint of the T2Dx Instruments and make direct-from-blood diagnostic tests available to new sepsis patients,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “The availability of the T2Resistance Panel in international markets strengthens the value proposition of our T2Dx platform and we believe the clinical experience using direct-from-blood detection of antibiotic resistance genes in these markets is an important precursor to our U.S. launch of the T2Resistance Panel. We previously received Breakthrough Device designation from the FDA for the T2Resistance Panel and plan to submit a FDA 510(k) premarket notification next quarter.”
The T2Resistance Panel, which runs on the FDA-cleared T2Dx® Instrument, is a direct-from-blood test panel that detects 13 antibiotic resistance genes from both Gram-positive and Gram-negative bacterial pathogens (KPC, OXA-48, CTX-M-14/15, AmpC (CMY/DHA), NDM/IMP/VIM, mecA/C, vanA/B) in 3-5 hours, without the need to wait for a positive blood culture. The T2Resistance Panel is commercially available in Europe under a CE-mark and was granted “Breakthrough Device” designation from the FDA, which provides for a prioritized FDA review process. In March 2024, the Company announced the results of a new prospective study that was published in the Journal of Clinical Microbiology, highlighting the performance and clinical benefits of the T2Resistance Panel compared to blood culture and standard microbiology methods, including high accuracy (i.e., 94.7% sensitivity, 97.4% specificity), rapid turnaround time (i.e., results available in 4.4 hours vs. 58.3 hours), and clinical impact (i.e., clinical interventions in 41% of patients in the study; 24 of 59 patients).
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology and include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the T2Lyme™ Panel, and the expended T2Candida Panel to add the detection of Candida auris. For more information, please visit www.t2biosystems.com.
