T2 Biosystems Forges Sales Deal With Cardinal Health for Sepsis Test

Cardinal Health has agreed to sell T2 Biosystems Inc.’s sepsis detection diagnostics.

The multi-year U.S. agreement gives Cardinal Health exclusive rights to sell T2 Biosystems’ U.S. Food and Drug Administration (FDA)-cleared direct-from-blood diagnostics for detecting sepsis-causing pathogens, including the T2Dx Instrument, the T2Bacteria Panel, and the T2Candida Panel.

“We are thrilled to have entered into a distribution agreement with Cardinal Health that will make them the exclusive distributor of our FDA-cleared direct-from-blood diagnostics in the United States, which will dramatically increase our representation with hospital customers who are eager to add culture-independent diagnostics to strengthen their sepsis clinical care,” T2 Biosystems Chairman/CEO John Sperzel said. “We expect this collaboration to greatly expand our access to the U.S. hospital market as Cardinal Health has an extensive commercial and distribution infrastructure that includes capital equipment specialists who will sell the T2Dx Instrument.”

Despite the widespread use of blood culture-based diagnostics to detect sepsis-causing pathogens and antibiotic susceptibility, sepsis is the leading cause of death in U.S. hospitals and kills approximately 350,000 Americans annually.¹ Sepsis also costs the U.S. healthcare system an estimated $62 billion annually² and is the leading cause of 30-day hospital readmission in the United States, with 19% of sepsis survivors re-hospitalized within 30 days and 40% within 90 days.^3,4,5

A September 2024 article in The Lancet, “The Culture of Blood Culture,” described the weakness of blood culture, including poor sensitivity (i.e., missed infections), slow time to result (i.e., typically two to three days); vulnerability to contamination; reduced effectiveness in patients who have received antibiotics; and a labor-intensive process requiring skilled technicians.

T2 Biosystems has developed the only FDA-cleared diagnostics to detect sepsis-causing bacterial and fungal pathogens directly from blood in three to five hours. The T2Bacteria Panel runs on the FDA-cleared T2Dx Instrument and detects six pathogens that account for nearly 75% of U.S. bacterial bloodstream infections, with 90% sensitivity and 98% specificity, including E. faecium, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa, and E. coli. The T2Candida Panel runs on the FDA-cleared T2Dx Instrument and detects five Candida species that account for up to 95% of U.S. Candida blood stream infections, with 91% sensitivity and 99% specificity, including C. albicans, C. tropicalis, C. parapsilosis, C. krusei, and C. glabrata. The T2 Biosystems test panels are not affected by prior antimicrobial treatment.

Cardinal Health distributes pharmaceuticals, manufactures and distributes medical and laboratory products, and provides performance and data solutions for healthcare facilities. The company has been in business for more than half a century, maintains operations in more than 30 countries and employs approximately 48,000 workers globally.

T2 Biosystems develops rapid detection solutions for sepsis-causing pathogens and antibiotic resistance genes to help clinicians effectively and quickly treat patients. 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 expanded T2Candida Panel to add the detection of Candida auris.

References
¹ Centers for Disease Control https://www.cdc.gov/mmwr/volumes/72/wr/mm7234a2.htm
² Buchman, T. G., Simpson, S. Q., Sciarretta, K. L., Finne, K. P., Sowers, N., Collier, M., … & Kelman, J. A. (2020). Sepsis among medicare beneficiaries: 3. The methods, models, and forecasts of sepsis, 2012–2018. Critical care medicine, 48(3), 302-318.
https://journals.lww.com/ccmjournal/FullText/2020/03000/Sepsis_Among_Medicare_Beneficiaries__3__The.4.as
³ Fingar K, Washington R. HCUP Statistical Brief #196. November 2015. Agency for Healthcare Research and Quality, Rockville, MD. https://www.hcup-us.ahrq.gov/reports/statbriefs/sb196-Readmissions-Trends-High-Volume-Conditions.jsp
⁴ Gadre SK, et al. Chest. 2019;155(3):483-490. https://journal.chestnet.org/article/S0012-3692(18)32895-2/abstract
⁵ Prescott H and Angus D. JAMA. 2018;319(1):91. https://jamanetwork.com/journals/jama/fullarticle/2667724å