Comprehensive hemostasis profiling at point of care
Currently in development, the T2HemoStat Panel is designed to be the first test to rapidly provide comprehensive hemostasis measurements directly from whole blood at the point of care. The panel, which will run on the T2Plex Instrument, is intended to provide data across the hemostasis spectrum including measurements of clotting time, fibrinogen, fibrinolysis, and platelet activity.
T2HemoStat is designed to provide the following advantages:
- Rapid comprehensive results
- Results from clinical samples as small as a finger stick of blood
- Compact instrument that can be used at the point of care
- Easy-to-use system that novice technicians can operate
- Potential to replace multiple instruments with one compact instrument
Rapid information for more effective treatment decisions
There is a significant unmet clinical need for the diagnosis and management of impaired hemostasis, which is a life-threatening condition. Patients with impaired hemostasis are either unable to promote the formation of blood clots to stabilize excessive bleeding or are hypercoaguable, with clots forming when they are not medically necessary.
There are over ten million trauma patients in the United States annually who present with symptoms of impaired hemostasis.1,2 For critical trauma patients with impaired hemostasis, diagnostic results are required in fewer than 45 minutes to aid clinicians in making the most effective treatment decisions. According to a study in the Journal of the American College of Surgeons, in trauma patients with symptoms of impaired hemostasis, mortality was reduced from 45% to 19% with more rapid delivery of appropriate therapy.3
This need for rapid information is not met by current diagnostic methods, which typically involve multiple instruments and can take hours to process a patient specimen. As a result, physicians often make critical decisions for treatment of impaired hemostasis with limited or no diagnostic data.
Designed to reduce mortality and costs
The first T2HemoStat clinical applications are focused on addressing the unmet need for trauma patients. More rapid delivery of directed therapy for patients with impaired hemostasis has been shown to deliver the following benefits:
- Reduction of mortality rate from 45% to 19%3
- A decrease in length of hospital stay by 20%4
- Reduction of healthcare costs by nearly $2 billion each year5
Beyond trauma, T2HemoStat can be expanded to add diagnostic tests that may address the needs of the broader population of patients with impaired hemostasis.
T2HemoStat is designed to provide novel signatures, as well as measure known parameters of hemostasis on a single instrument. Currently, T2HemoStat is available as a research tool for use in drug development and animal studies, providing more efficient and informative pharmacokinetics/pharmacodynamics.
The T2Dx Instrument and T2Candida Panel have received marketing authorization from the U.S. Food and Drug Administration. All other T2 Biosystems products are considered investigational and for research use only.
1. CDC, February 2014
2. Brohi, K., Singh, J., Heron, M., & Coats, T. (2003). Acute traumatic coagulopathy. Journal of Trauma and Acute Care Surgery, 54(6), 1127-1130.
3. Riskin, D. J., et al. Journal of the American College of Surgeons, 209(2), 198-205.
4. Premier healthcare alliance economic outlook – Fall 2012.
5. Arch Surg Vol. 143 No. 7, July 2008