Guardant Health, Inc. - GH STOCK NEWS

Guardant Health has launched an upgraded version of its Guardant360 TissueNext test, which now identifies 498 genes or cancer biomarkers. This expanded gene panel helps oncologists find more targeted therapies for patients with advanced cancer. Additionally, operational improvements have streamlined the workflow, reducing the time to results to less than two weeks. The test is covered by Medicare for patients with advanced solid tumors. Guardant Health aims to improve patient outcomes by providing more comprehensive gene coverage. This new test can be ordered either alone or in combination with Guardant360 CDx to support guideline-recommended genomic profiling for advanced breast and lung cancer.

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.