Why Guardant Health Stock Surged Nearly 9% Higher Today
A new designation
This morning before market open, Guardant announced that the U.S. Food and Drug Administration (FDA) had granted the healthcare company's Shield multi-cancer detection (MCD) test its Breakthrough Device designation.
This instantly confers a high status on Shield, as the FDA's designation is given only to a small clutch of medical devices that can either diagnose or treat a disease more effectively than other products.
In Shield's case, it is quite a versatile diagnostic device that can screen for a wide range of cancers, including colorectal, lung, and ovarian. It is designed to evaluate people 45 years of age or older who are at a typical average risk for cancer. According to Guardant, Shield has 98.6% specificity and 75% sensitivity in detecting certain cancers.
In its news release touting the FDA's move, Guardant quoted its co-CEO AmirAli Talasaz as saying that it "shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw."
"We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly," he added.
Coming to market soon
Another big plus of the Breakthrough Device designation is that it's part of an FDA initiative aimed at getting useful medical products to market faster. Talasaz and his team at Guardant might just get their wish with Shield before long.
Should you invest $1,000 in Guardant Health right now?
Before you buy stock in Guardant Health, consider this:
The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Guardant Health wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years.
Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $657,385!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $842,015!*
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