Cancer Genetics Inc (NASDAQ: CGIX) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that the FDA has provided special 510(k) clearance from the United States Food and Drgu Administration (FDA). Of course, this excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The FDA clearance;
- what we’re seeing from the stock as a result;
- and what we’ll be watching for ahead.
FDA Provides CGIX With Special 510(k) Clearance
As mentioned above, Cancer Genetics is having an overwhelmingly strong start to the trading session this morning after announcing that it has received special 510(k) clearance from the FDA. In a press release issued early this morning, the company announced that it has received the clearance from the FDA surrounding its Tissue of Origin test, also known as TOO® after the company made modifications to test reagents and software. In a statement, John A. (Jay) Roberts, Interim CEO and COO at CGIX, had the following to offer:
Our TOO® Test represents a unique offering with the ability to add significant value to the continuum of care for cancer patients and greatly enhance our biopharma partners’ development efforts. This 510(k) clearance represents an important milestone toward our goal of gaining broad adoption of the test… An important element of our recently implemented transformation strategy is the identification of new methods through which to monetize our world-class test portfolio. We are currently evaluating several partnering opportunities that would expand the reach of the TOO® Test and have the potential to generate high-margin revenue streams. We look forward to continuing this process as we leverage the capabilities of TOO® to drive future growth.
What We’re Seeing From The Stock
With the news of the clearance from the FDA, Cancer Genetics now has the ability to commercialize TOO®, generating revenue from sales. Of course, this led to excitement among investors who are sending the stock screaming for the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:56), CGIX is trading at $1.33 per share after a gain of $0.36 per share or 37.18% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on CGIX. In particular, we’re interested in following the commercialization efforts surrounding TOO® following the approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!