FDA Panel to Evaluate Guardant Health Colorectal Test on March 28

December 20, 2023

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On March 28th, a panel from the Food and Drug Administration (FDA) will be evaluating Guardant Health ($NASDAQ:GH)’s colorectal test. Guardant Health is a leading precision oncology company that has developed breakthrough technology to improve clinical outcomes in cancer treatment. Their liquid biopsy technology is used to detect and monitor changes in the DNA of cancer cells, enabling physicians to make personalized treatment decisions for their patients. The FDA panel will be assessing the utility of the Guardant Health colorectal test in patients with early-stage colorectal cancer. This test is designed to detect mutations in key genes associated with colorectal cancer, providing critical information about the tumor and helping to guide treatment decisions.

If approved, this test could provide a more comprehensive and accurate diagnosis than current methods, allowing for better individualized care and improved patient outcomes. This assessment marks a significant milestone in Guardant Health’s effort to bring their innovative technology to the market. If approved, this test could revolutionize the way colorectal cancer is diagnosed and treated, setting a new standard of care for healthcare providers and patients alike. The FDA panel’s decision on March 28th will be a key indicator of the future of precision oncology.

Share Price

On Tuesday, the stock of GUARDANT HEALTH opened at $27.8 and closed at $27.9, marking a 2.5% increase from its last closing price of 27.2. This surge in share prices came following news that the U.S. Food and Drug Administration (FDA) will hold an advisory committee meeting on March 28th to evaluate Guardant Health’s colorectal cancer screening test. The company has developed a novel non-invasive liquid biopsy test, which consists of sequencing DNA fragments found in a patient’s blood in order to identify mutations associated with the presence of colorectal cancer.

If approved, the test would provide an accurate, easy-to-administer alternative to current colorectal cancer screening methods such as colonoscopies and stool tests. This is an important step for Guardant Health, as successful FDA approval of this test could result in increased demand for the company’s products and services, which in turn could drive further growth. Live Quote…

About the Company

  • Industry Classification
  • Key Executives
  • Ownership (Institutional/ Fund Holdings)
  • News Feed
  • Income Snapshot

    Below shows the total revenue, net income and net margin for Guardant Health. More…

    Total Revenues Net Income Net Margin
    535.78 -432.34 -80.7%
  • Income Statement Reports (Yearly/ Quarterly/ LTM)
  • Income Supplement
  • Growth Performance
  • Cash Flow Snapshot

    Below shows the cash from operations, investing and financing for Guardant Health. More…

    Operations Investing Financing
    -337 247.42 389.12
  • Cash Flow Statement (Yearly/ Quarterly/ LTM)
  • Cash Flow Supplement
  • Balance Sheet Snapshot

    Below shows the total assets, liabilities and book value per share for Guardant Health. More…

    Total Assets Total Liabilities Book Value Per Share
    1.8k 1.57k 1.93
  • Balance Sheet (Yearly/ Quarterly)
  • Balance Sheet Supplement
  • Key Ratios Snapshot

    Some of the financial key ratios for Guardant Health are shown below. More…

    3Y Rev Growth 3Y Operating Profit Growth Operating Margin
    25.5% -79.9%
    FCF Margin ROE ROA
    -67.8% -102.7% -14.9%
  • Income Statement Ratios
  • Balance Sheet Ratios
  • Cash Flow Ratios
  • Valuation Ratios
  • Other Ratios
  • Other Supplementary Items
  • Analysis

    GoodWhale has conducted an analysis of GUARDANT HEALTH‘s wellbeing and, according to our Star Chart, we can see that the company has a low health score of only 3/10. This is because of its weak cashflows and debt, which suggests that it is not likely to be able to pay off debt and fund future operations. In terms of the company’s growth, assets and dividends, GoodWhale scores GUARDANT HEALTH as strong in growth, medium in assets and weak in dividend and profitability. This means that the company has achieved high revenue or earnings growth, but is considered less stable due to its lower profitability. Because of this, GoodWhale classifies GUARDANT HEALTH as ‘cheetah’. So, investors who are looking for higher risk, higher return investments may be interested in this company. More…

  • Star Chart Analysis
  • Valuation Analysis




  • Peers

    The competition in the market for cancer detection and treatment is heating up. Guardant Health Inc, a leading player in the field, is up against some stiff competition from the likes of Aclaris Therapeutics Inc, Inoviq Ltd, and Biomark Diagnostics Inc. All these companies are vying for a share of the pie in this rapidly growing market. While Guardant Health Inc has a strong product portfolio and a good track record, its competitors are not far behind and are also making inroads into this market. It remains to be seen who will emerge victorious in this battle.

    – Aclaris Therapeutics Inc ($NASDAQ:ACRS)

    Aclaris Therapeutics Inc is a clinical-stage biopharmaceutical company focused on the development and commercialization of drugs for the treatment of dermatological and immuno-inflammatory diseases. The company’s lead product candidates include ATI-502 for the treatment of seborrheic keratosis, and ATI-501 for the treatment of vitiligo. Aclaris Therapeutics Inc has a market cap of 1.11B as of 2022, a Return on Equity of -25.42%.

    – Inoviq Ltd ($ASX:IIQ)

    Inoviq Ltd is a publicly traded company with a market capitalization of 50.61M as of 2022. The company’s return on equity (ROE) is -13.68%. Inoviq Ltd is engaged in the development and commercialization of innovative drugs and therapies. The company’s products are designed to improve the lives of patients with serious medical conditions. Inoviq’s products are available in more than 60 countries worldwide.

    – Biomark Diagnostics Inc ($OTCPK:BMKDF)

    Biomark Diagnostics Inc is a company that provides diagnostic testing services. The company has a market capitalization of 10.88 million as of 2022 and a return on equity of 179.57%. The company’s diagnostic testing services include tests for cancer, cardiovascular disease, and infectious diseases. Biomark Diagnostics Inc is headquartered in the United States.

    Summary

    Guardant Health is a leading precision oncology company that offers a comprehensive liquid biopsy test for colorectal cancer. On March 28th, the U.S. Food and Drug Administration (FDA) will review Guardant Health’s colorectal cancer liquid biopsy test for approval. If approved, this test could provide an efficient and cost-effective alternative to traditional colonoscopy for colorectal cancer screening. Investors interested in Guardant Health should consider its competitive advantages such as its advanced technology and advanced data analytics capabilities.

    Additionally, the company has a strong financial position with significant cash and marketable securities on its balance sheet. Furthermore, Guardant Health has entered into strategic partnerships with many leading healthcare companies, which provides the company with additional potential revenue streams. All of these factors offer compelling potential for long-term growth and make Guardant Health an attractive investment opportunity.

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