T2 Biosystems Inc (TTOO)

[green maschine]

Clearance could be very soon my friend.

"We applaud the CDC and Director Dr. Mandy Cohen for taking action to address the sepsis crisis that is plaguing U.S. hospitals and causing the death of hundreds of thousands of Americans each year,” stated John Sperzel, Chairman and CEO at T2 Biosystems. “We cannot continue to rely on decades-old technologies and past processes that are failing patients, payors, and providers. We believe CDC’s leadership will serve as a catalyst to accelerate the adoption of new products and technologies that can enhance the standard of care, reduce cost, and improve patient outcomes.”

Sepsis is the leading cause of death in U.S. hospitals, causing the death of approximately 350,000 Americans each year, including 80,000 following discharges to hospice. Sepsis is the leading cost of U.S. hospitalization, costing the U.S. healthcare system $62 billion annually, as well as the leading cause of 30-day re-hospitalization in the U.S., causing 19% of sepsis survivors to be re-hospitalized within 30 days and 40% to be re-hospitalized within 90 days.

"...the T2Candida® Panel, are the first and only FDA-cleared products able to detect sepsis-causing pathogens directly from whole blood, in 3-5 hours, without the need to wait days for a positive blood culture. The limitations of blood culture are well-known, including poor sensitivity and lengthy time to result. A meta-analysis of 14 controlled studies was published in a peer-reviewed medical journal and compared the use of T2 Biosystems’ products to blood culture-based protocols. T2 Biosystems’ products identified sepsis-causing pathogens 77 hours faster, allowed patients to receive targeted antimicrobial 42 hours faster, allowed clinicians to de-escalate from empiric therapy 7 hours faster, and reduced length of stay on the hospital and ICU by approximately 5 days."