US-based sepsis diagnostics company T2 Biosystems has signed a multi-year exclusive US distribution agreement with healthcare services company Cardinal Health.
T2 Biosystems develops diagnostic products for rapid and accurate detection of sepsis-causing pathogens and antibiotic resistance genes.
Cardinal Health is a distributor of pharmaceuticals, medical and laboratory products, and a provider of performance and data solutions for healthcare facilities.
Under the agreement, Cardinal Health will obtain exclusive rights to sell T2 Biosystems’ US Food and Drug Administration (FDA)-approved diagnostics products, in the US.
The products include the T2Dx Instrument, the T2Bacteria Panel, and the T2Candida Panel, for the rapid detection of sepsis-causing pathogens.
T2 Biosystems chairman and CEO John Sperzel said: “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 US.
“We expect this collaboration to greatly expand our access to the US hospital market as Cardinal Health has an extensive commercial and distribution infrastructure that includes capital equipment specialists who will sell the T2Dx Instrument.”
According to the diagnostics company, blood culture-based diagnostics are widely used to detect sepsis-causing pathogens and antibiotic susceptibility.
However, sepsis remains the major cause of hospital death, hospitalisation cost, the 30-day hospital readmission in the US, with 19% of sepsis survivors re-hospitalised within 30 days.
T2 Biosystems said that its FDA-approved diagnostics can detect sepsis-causing bacterial and fungal pathogens directly from blood within three to five hours, instead of days.
Its T2Bacteria Panel runs on the FDA-approved T2Dx Instrument and detects six pathogens which account for nearly 75% of bacterial bloodstream infections in the US.
With 90% sensitivity and 98% specificity, the panel can detect pathogens including E. faecium, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa, and E. coli.
Its T2Candida Panel runs on the FDA-cleared T2Dx Instrument and detects five Candida species which are responsible for up to 95% of Candida blood stream infections in the US.
The panel shows 91% sensitivity and 99% specificity in detecting Candida species C. albicans, C. tropicalis, C. parapsilosis, C. krusei, and C. glabrata.
Furthermore, its panels are not affected by prior antimicrobial treatment, said T2 Biosystems.