PALO ALTO, Calif. – Guardant Health , Inc. (NASDAQ:), a precision oncology company, has announced that its premarket approval (PMA) application for the Shield blood test, aimed at screening for colorectal cancer (CRC), is set for review by the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration Medical Devices Advisory Committee on May 23, 2024.
The Shield blood test is designed to detect CRC at early stages, which is typically when the disease is most treatable. The company’s co-CEO, AmirAli Talasaz, expressed optimism about the upcoming review and the potential for the Shield test to provide a more convenient option for CRC screening compared to current methods.
Guardant Health, founded in 2012, specializes in developing blood and tissue tests that offer insights into the genetic drivers of cancer. These tests are intended to improve patient outcomes at various stages, from early detection and monitoring for recurrence to guiding treatment decisions for advanced cancer.
The review by the FDA Advisory Committee represents a critical step for Guardant Health in potentially bringing the Shield blood test to market, pending approval.
This news is based on a press release statement from Guardant Health, Inc.
InvestingPro Insights
As Guardant Health, Inc. (NASDAQ:GH) prepares for a significant milestone with its Shield blood test, investors and industry watchers are closely monitoring the company’s financial health and market performance. According to real-time data from InvestingPro, Guardant Health has a market capitalization of approximately $1.96 billion, reflecting its standing in the precision oncology market.
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The company’s financial metrics indicate challenges and potential areas of focus for investors. Guardant Health has not been profitable over the last twelve months, with an adjusted P/E ratio as of Q4 2023 standing at -4.35. This aligns with an InvestingPro Tip that analysts do not anticipate the company will be profitable this year. Additionally, the company is trading at a high Price / Book multiple of 12.33, suggesting that its market value is considerably higher than its book value, which could be a point of analysis for value-focused investors.
Despite these challenges, Guardant Health’s liquid assets exceed its short-term obligations, providing some financial stability as it continues to invest in research and development. Moreover, the stock is trading near its 52-week low, which might attract investors looking for potential bargains in the biotechnology sector.
Investors interested in a deeper dive into Guardant Health’s financials and future outlook can find additional InvestingPro Tips on the company’s profile at Investing.com/pro/GH. There are currently 7 additional tips available, which could provide further insights into investment decisions. To access these insights, users can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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