Guardant Health Stock Price, News & Analysis

Guardant Health (NASDAQ: GH) has initiated a new study, Understanding Patient Preference on Colorectal Cancer Screening Options (U-Screen), to evaluate its Shield blood test's effectiveness in improving adherence to colorectal cancer (CRC) screenings among underserved populations. The study targets patients at Federally Qualified Health Centers (FQHC) who have not completed guideline-recommended screenings. The Shield test, which detects CRC via circulating tumor DNA, showed 83% sensitivity and approximately 90% adherence in real-world use. The research aims to address the significant barriers to CRC screening, particularly in minority groups.

Guardant Health (NASDAQ: GH) has announced that UnitedHealthcare (UHC) now covers the Guardant360 CDx liquid biopsy test for all FDA-approved indications in advanced or metastatic breast and non-small cell lung cancer (NSCLC) patients. This marks a significant expansion of the test's accessibility, making it available under UHC's commercial policies for enrolled patients. Guardant360 CDx is the first FDA-approved blood test for comprehensive genomic profiling in solid tumors and has been instrumental in matching patients with targeted therapies. With over 250,000 tests performed, its coverage by the largest U.S. national health insurer enhances patient access to critical genomic profiling.

Guardant Health and AnHeart Therapeutics announced a strategic collaboration focused on developing Guardant360 CDx and Guardant360 TissueNext assays as companion diagnostics for taletrectinib, an investigational ROS1 inhibitor targeting advanced non-small cell lung cancer (NSCLC). This partnership aims to expedite regulatory approval and improve patient access to advanced diagnostic tools. Taletrectinib has received FDA Breakthrough Therapy Designation for ROS1-positive NSCLC patients. The collaboration will utilize comprehensive genomic profiling to identify suitable patients for this therapy, enhancing treatment outcomes.

Guardant Health, Inc. (Nasdaq: GH) announced a favorable recommendation from U.S. District Court Magistrate Judge Christopher J. Burke regarding Illumina's lawsuit filed on March 17, 2022. The judge recommended that nearly all of Illumina's claims be dismissed, affirming Guardant's belief in the validity of its patent ownership. This dismissal is viewed as a significant step in Guardant's mission to enhance cancer care. Guardant Health continues to advance its precision oncology platform with various proprietary tests aimed at improving patient outcomes and reducing healthcare costs.

Guardant Health (NASDAQ: GH) is set to report its financial results for the fourth quarter and full year 2022 after market close on February 23, 2023. The corresponding conference call will start at 1:30 p.m. PT (4:30 p.m. ET). Listeners can access the live webcast and subsequent archive in the Investors section of the company’s website.

Guardant Health specializes in precision oncology, providing proprietary tests and advanced analytics aimed at improving cancer treatment outcomes and reducing healthcare costs.

Guardant Health (NASDAQ: GH) has unveiled Guardant Galaxy, a suite of AI-powered analytical technologies aimed at enhancing cancer testing and drug discovery. The first application, developed in collaboration with Lunit, improves biomarker detection by over 20% for the Guardant360 TissueNext PD-L1 test in non-small cell lung cancer cases. Future applications will focus on deep learning-driven genomic and epigenomic discovery, leveraging real-world clinical data from the GuardantINFORM platform. The initiative aims to provide oncologists with precise information and to accelerate biomarker discovery.

Guardant Health (GH) announced FDA approval for its Guardant360 CDx liquid biopsy test, which identifies advanced breast cancer patients with ESR1 mutations eligible for ORSERDU™ (elacestrant) therapy, a significant breakthrough for a major unmet medical need. This marks the first new endocrine therapy innovation in over 20 years, targeting the 40% of ER+/HER2- advanced breast cancers driven by ESR1 mutations. ORSERDU, developed by Stemline Therapeutics, is designed for patients whose disease has progressed after at least one line of endocrine therapy. The approval followed the Phase III EMERALD trial, demonstrating significant progression-free survival benefits.

Guardant Health (GH) partners with The Royal Marsden NHS Foundation Trust to conduct Part C of the TRACC study, evaluating the effectiveness of the Guardant Reveal™ blood test in guiding chemotherapy decisions for stage II-III colorectal cancer patients. The trial will involve over 1,600 patients at around 40 sites in the UK, aiming to determine if patients who test negative for circulating tumor DNA (ctDNA) can avoid unnecessary chemotherapy, thus reducing associated side effects. The study's aim is to enhance patient quality of life and optimize treatment protocols while potentially saving healthcare costs.

Guardant Health (NASDAQ: GH) will present new data at the ASCO 2023 Gastrointestinal Cancers Symposium from January 19-21 in San Francisco. The company will showcase 10 poster presentations emphasizing the roles of its blood tests, Guardant360 and Guardant Reveal, along with the GuardantINFORM dataset. These findings aim to enhance the understanding of biomarkers and predict disease recurrence in gastrointestinal cancers. Notably, the presentations will cover topics such as ctDNA-based detection in colorectal cancers and treatment response assessments, highlighting the potential of liquid biopsies in personalized oncology.