T2 Biosystems (TTOO) Stock: Headed Up On FDA Clearance

T2 Biosystems Inc TTOO Stock NewsT2 Biosystems Inc (NASDAQ: TTOO) is having a great start to the trading session this morning, and for good reason. The company announced FDA news that led to excitement among investors who are pushing the stock toward the top. Today, we’ll talk about:

  • The news;
  • what we’re seeing from the stock;
  • and what we’ll be watching for with regard to TTOO ahead.

TTOO Announces FDA News

As mentioned above, TTOO is having a strong start to the trading session in the pre-market hours after announcing FDA news. In a press release issued early this morning, the company announced that it has received market clearance from the United States Food and Drug Administration (FDA) for the T2Bacteria® Panel. The approval surrounds the direct detection of bacterial species in human whole blood specimens from patients that are suspected of having blood stream infections.

In the release, TTOO said that this particular test is set apart from all other FDA-approved diagnostic tests that test for bacteria. The difference is that all other approved options require a positive blood culture sample prior to bacterial species specific identification. That process generally delays results by between one and five days. However, this is not the case with regard to the T2Bacteria® Panel, which could make it the go-to option on the market considering that it is estimated that every hour of time to targeted therapy decreases mortality by approximately 8%. In a statement, John McDonough, President and CEO at TTOO, had the following to offer:

The FDA’s market clearance of the T2Bacteria Panel is a significant milestone for our company, but more importantly, for millions of patients at risk of sepsis from bloodstream infections… This breakthrough technology provides potentially life-saving answers for patients and economic savings to hospitals that bear the enormous burden of sepsis-related care and mortality.

What We’re Seeing From The Stock

One of the first lessons that we learn when we start to dabble in the market is that the news causes moves. In the case of T2 Biosystems, the news proved to be overwhelmingly positive. Not only did the company receive clearance from the FDA to market this diagnostic test, the fact that the test can cut delays by between one and five days could prove to be a life saver for many. As a result, it could become the first-line option when testing for bacterial infections in the blood. So, it’s no surprise that excited investors are sending the stock on a run for the top. At the moment (9:04), TTOO is trading at $9.15 per share after a gain of $0.28 per share or 3.16% 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 efforts to commercialize the T2Bacteria® Panel, now that FDA clearance is in the bag. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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