Welcome to our dedicated page for Guardant Health news (Ticker: GH), a resource for investors and traders seeking the latest updates and insights on Guardant Health stock.
Guardant Health (GH) is a leader in precision oncology, pioneering non-invasive liquid biopsy tests for cancer detection and monitoring. This dedicated news hub provides investors and healthcare professionals with timely updates on the company's financial performance, clinical advancements, and strategic initiatives.
Access authoritative coverage of earnings reports, regulatory milestones, and technology innovations shaping cancer diagnostics. Our curated collection includes press releases on clinical trial results, partnership announcements, and peer-reviewed research developments directly from Guardant Health's communications.
Key updates cover FDA clearances for diagnostic assays, global commercialization efforts, and data partnerships advancing precision medicine. Stay informed about developments in molecular residual disease detection, expanded test indications, and reimbursement progress affecting healthcare adoption.
Bookmark this page for consolidated access to verified information about liquid biopsy advancements and GH's role in transforming cancer care through genomic insights. Check regularly for objective reporting on developments impacting both clinical practice and investment considerations.
Guardant Health (NASDAQ:GH), a precision oncology company, has been named to the TIME100 Most Influential Companies list. This recognition comes due to the company's impact, innovation, ambition, and success.
Guardant was included in the Innovators section, which features 20 companies from various industries. Key milestones for Guardant include achieving 500 peer-reviewed publications and delivering 500,000 patient tests.
Additionally, the FDA’s Medical Devices Advisory Committee has recommended approval for Shield™, Guardant's blood test for colorectal cancer screening. The FDA's decision is expected later this year.
Guardant Health (Nasdaq: GH) will present data from 16 studies at the 2024 ASCO Annual Meeting, May 31-June 4 in Chicago. The studies highlight the impact of Guardant's blood tests and real-world data on precision oncology and cancer screening. Key presentations include interim data from the RADIOHEAD study showing correlations between epigenomic biomarkers and immunotherapy responses across 13 cancer types.
Presentations will cover the utility of ctDNA for therapy response monitoring, the use of the GuardantINFORM clinical-genomic database to study tumor drivers and resistance, and applications of genomic and epigenomic biomarkers in cancer treatment. Featured studies focus on racial differences in genomic profiles in metastatic breast cancer and the quantification of tumor fractions using the Guardant Infinity platform.
The FDA's Molecular and Clinical Genetics Panel has strongly recommended the approval of Guardant Health's Shield™ blood test for colorectal cancer (CRC) screening in adults aged 45 and older at average risk. The panel's vote was 8 to 1 for safety, 6 to 3 for effectiveness, and 7 to 2 for benefits outweighing risks. Shield aims to improve CRC screening rates by offering a non-invasive alternative to stool-based tests. Shield demonstrated 83% sensitivity and 90% specificity for advanced neoplasia in the pivotal ECLIPSE study, aligning with existing non-invasive tests. The FDA is expected to make its decision later this year.
Guardant Health (Nasdaq: GH) announced a temporary halt in trading of its stock on Nasdaq. This pause precedes a important meeting of the FDA's Molecular and Clinical Genetics Panel, which will review the premarket approval application for Shield™, Guardant Health’s blood test aimed at screening colorectal cancer in average-risk adults. The panel meeting, starting at 9:30 a.m. ET, will provide independent expert advice to the FDA to support its decision-making process.
Guardant Health (Nasdaq: GH), a precision oncology company, announced its participation in three upcoming investor conferences.
These include the William Blair 44th Annual Growth Stock Conference in Chicago on June 4, the Jefferies Global Healthcare Conference in New York on June 5, and the Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, Florida on June 11.
Live and archived webcasts of these sessions will be available on Guardant Health's website under the 'Investors' section.
Guardant Health announced EU IVDR certification for its Guardant360 CDx liquid biopsy, allowing comprehensive genomic profiling across all solid cancers.
Certification by TÜV SÜD provides a significant milestone, ensuring compliance with stricter EU regulatory standards. This enables broader adoption and faster access to genomic profiling, aiding personalized treatment for advanced cancer patients.
Guardant360 CDx identifies somatic mutations using a blood sample, facilitating targeted therapies for non-small cell lung and breast cancer.
Clinical studies suggest that targeted therapies result in improved progression-free survival and higher response rates.
Adoption of genomic profiling with IVDR-certified liquid biopsy can address challenges like insufficient tissue for molecular profiling, ultimately benefiting more cancer patients.
Since its introduction, Guardant360 has been widely accepted, with over 500,000 tests performed and more than 400 peer-reviewed publications.
Guardant Health (Nasdaq: GH) announced on April 22, 2024, that its Compensation Committee has approved the granting of restricted stock units (RSUs) and non-qualified stock options to new non-executive employees under its 2023 Employment Inducement Incentive Award Plan. This move, compliant with Nasdaq Listing Rule 5635(c)(4), involves RSUs representing 215,601 shares of common stock to 94 employees and stock options to purchase 98,076 shares to three employees. The RSUs and stock options have a vesting schedule tied to continued employment, with stock options priced at $24.00 per share, the closing price on May 13, 2024.
Guardant Health (Nasdaq: GH) will present real-world data supporting the performance of its Shield™ blood test for colorectal cancer (CRC) screening at the 2024 Digestive Disease Week (DDW) in Washington, DC. The Shield test aims to increase CRC screening rates by offering a more convenient and less unpleasant method compared to traditional options. Presentations will include data showing improved screening rates and early detection of CRC. Initial results from the ECLIPSE study, validating Shield’s performance, were unveiled at the 2023 DDW, leading to a premarket approval (PMA) application to the FDA. An FDA Advisory Panel is set to review this application on May 23, 2024.
Guardant Health reported a 31% increase in revenue for the first quarter of 2024 compared to the same period in 2023. The company achieved significant revenue growth in precision oncology, driven by increased testing volume and reimbursement rates. Despite a decrease in free cash flow, Guardant Health raised its 2024 revenue guidance to $675-$685 million, showcasing a positive outlook for the year. The company also highlighted key milestones achieved in clinical data validation, product launches, and publication impact.
Guardant Health, Inc. (Nasdaq: GH) will participate in upcoming investor conferences including the BofA Securities 2024 Healthcare Conference and Leerink Partners 2024 Healthcare Crossroads Conference. Interested parties can access live and archived webcasts of the sessions on the company website.
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