T2 Biosystems Inc (NASDAQ: TTOO) is having an incredibly strong start to the trading session this morning, and for good reason. Th company announced that it has been granted Breakthrough Device designation.
As you would imagine, the news excited investors, pushing the stock on a run for the top. Today, we’ll talk about:
- The Breakthrough Device designation;
- what we’re seeing from TTOO stock as a result; and
- what we’ll be watching for ahead.
FDA Grants TTOO Breakthrough Device Designation
As mentioned above, T2 Biosystems is having an incredibly strong start to the trading session this morning after announcing that it has received Breakthrough Device designation. The deisgnation was provided to its T2Resistance Panel.
The T2Resistance Panel is a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens. This can be done using a single patient blood sample without having to wait for blood culture.
TTOO said that the 13 genes identified in the panel include the most clinically important. The company said that these genes largely resist to antimicrobial drugs for certain patients, which are crucial in the tratment of bacterial infections. All of them are on the CDC’s Urgent Threat list for antibiotic resistance.
In a statement, Sandy Estrada, PharmD, Vice President of Medical Affairs at T2 Biosystems and President of Forida Health-System Pharmacists Organization, had the following to offer:
Under the current standard of care, diagnosing bloodstream infections caused by antimicrobial resistant pathogens requires a positive blood culture and subsequent analyses to determine exactly what medication will most effectively treat the infected patient. These conventional methods, including blood cultures and antimicrobial susceptibility testing (AST), take 3 or more days to provide an actionable result. This leads doctors to start their patients on broad spectrum antibiotics before they even know exactly what they need.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to T2 Biosystems, the news proved to be overwhelmingly positive.
Breakthrough Device designation comes with several benefits. Some of these include the additional support from the FDA and a shorter path to potential approval.
So, it’s not surprising to see that investors are excitedly sending the stock on a run for the top. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:14), TTOO is trading at $4.48 per share after a gain of $0.72 per share or 19.15% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on TTOO. In particular, we’re interested in following the story surrounding the company’s continued work to bring its T2Resistance panel to market. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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