Shares of T2 Biosystems (NASDAQ:TTOO) are soaring up over 20% today on the heels of receiving a 510(k) clearance for its T2Biothreat from the FDA. This unique test directly detects six biothreat pathogens from a blood sample.

Spotting Biothreats Faster:
T2Biothreat Panel is a game-changer, being the first and only FDA-approved product that can spot these critical biothreat pathogens simultaneously. T2 Biosystems proudly stands as the first U.S. company to achieve this milestone, reshaping the field of biothreat detection.
Big Investor Sells:
Interestingly while celebrating this achievement, a significant investor, CR Group (CRG), decided to sell off a substantial chunk of shares. This sell-off, totaling 24.81 million shares, took place between Sept. 20 and Sept. 26. The timing of this sell-off alongside the FDA clearance raises some eyebrows.
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New CDC Guidelines:
Regardless of CR Group selling, there still appears to be a massive opportunity according to many retail investors. Following new CDC guidelines, the U.S. government now mandates that all hospitals in the country must adopt rapid testing protocols to combat the sepsis pandemic by 2026, or risk losing Medicare funding.
Buying opportunity of the year!!! Update
byu/den1183 inTTOOstock
T2 Biosystems stands as the exclusive FDA-cleared product capable of achieving 100% accurate sepsis detection within 3 to 5 hours. Anticipating widespread adoption of T2 instruments in hospitals, the CEO foresees significant revenue generation, potentially reaching $1.3 billion annually, given the mandate.
This development drastically alters the landscape, potentially influencing the stock’s trajectory positively. With the ongoing surge in manufacturing hires and likely acceleration in orders, coupled with potential government contracts or international sales, many beleive T2 Biosystems presents an undervalued opportunity for investors.
What Borrowing Costs Tell Us:
Another interesting indicator to look at is the cost to borrow (CTB) fee. In terms of TTOO’s case, the stock has seen a massive surge in CTB fees, indicating a high demand from short sellers. When compared to the average CTB fee for other stocks, it’s pretty drastic. While this is typically not a very positive sign, retail investors seem to be buzzing with interest, given there also could be a potential short squeeze if enough buying comes in to trap the shorts.
Better News for Patients:
But let’s not forget the real impact and that’s what TTOO can do for patients. @ChengKeki a user from Twitter also shared an article about Butler Memorial Hospital and their approach to Sepsis. The hospital came up with a 2 step approach to expedite patient care. They’re utilizing the Beckman Coulter automation line to identify changes in a person’s blood cells that might indicate the development of sepsis. Which apparently has only been used in Europe and they’re the first in the US with the technology. Then shortly after, they use T2 Biosystems panels that as you know, quicken the process from 36 hours, to just 3-5 hours.
Catching sepsis quickly is crucial because it’s a life-threatening condition that rapidly progresses throughout your body and can lead to death if not promptly diagnosed and treated. Sepsis occurs when the body responds improperly to an infection, causing widespread inflammation and potentially damages multiple organ systems. Early detection allows for immediate medical intervention.
Conclusion:
T2 Biosystems is hitting major milestones, not only in the market but in improving critical healthcare processes. The company is also a major hit with retail investors and continues to trade an astronomical amount of shares daily, the current average is ~115M shares. The FDA approval and its implications, along with the positive shift in sepsis diagnosis, showcase T2 Biosystems’ growing role in healthcare. Keep an eye on how this progresses—it’s exciting for both investors and patients alike.
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