Precision oncology specialist Guardant Health (NASDAQ: GH) was something of a stock market star on Tuesday. On the back of very positive news in the regulatory sphere, the company’s shares jumped almost 9% higher today. This made it quite the outperformer on the exchange, as the bellwether S&P 500 index’s gain was a relatively modest 0.6%.
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.
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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.
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Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Guardant Health. The Motley Fool has a disclosure policy.
