Guardant Health, Inc. - GH STOCK NEWS

Guardant Health (NASDAQ:GH) has unveiled a major upgrade to its Guardant360 liquid biopsy test, running on the Guardant Infinity smart liquid biopsy platform. The enhanced test now covers 739 genes, a tenfold increase from its predecessor, and includes all guideline-recommended genomic biomarkers for advanced solid tumors. It offers 10 times higher sensitivity in quantifying tumor burden and can identify emerging biomarkers for precise cancer characterization.

Key features of the upgrade include:

• Broader gene panel coverage
• Analysis of both actionable and emerging biomarkers
• Results delivered in 7-10 days
• Medicare and major private payer coverage
• Improved precision in treatment strategy identification

The test's expansion aims to provide oncologists with a more comprehensive view of cancer, potentially improving patient outcomes through more targeted treatment options.

Guardant Health (NASDAQ:GH), a leader in precision oncology, has appointed Dr. Manuel Hidalgo Medina to its board of directors. Dr. Hidalgo, currently the Chief of Hematology and Medical Oncology at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, brings extensive expertise in translational and clinical research, particularly in anticancer drug development. His appointment is expected to contribute significantly to Guardant Health's mission of improving patient outcomes through advanced diagnostics.

Dr. Hidalgo's impressive career includes leadership roles at Beth Israel Deaconess Medical Center, the Spanish National Cancer Research Centre, and the Kimmel Comprehensive Cancer Center. He also serves on the board of Bristol Myers Squibb, further enhancing his industry insights.

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.