Guardant Health Stock Price, News & Analysis

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.

Guardant Health (NASDAQ: GH) reported preliminary, unaudited results for 2022, showing a revenue increase of 20% to between $447 million and $450 million. Clinical and biopharma test volumes rose by 42% and 40%, with 124,800 and 26,000 tests respectively. For Q4 2022, revenue was projected between $124 million and $127 million, up 15%-17% year-over-year. The company ended the year with $1 billion in cash and equivalents. Analysts express optimism for continued double-digit growth in 2023.

Guardant Health, a leading precision oncology company, will participate in the 41^st Annual J.P. Morgan Healthcare Conference on January 9, at 3:00 p.m. PT. The management will present and engage in a Q&A session, with a live and archived webcast available on their website. Guardant Health is known for its innovative cancer testing solutions, including Guardant360^® and Guardant Reveal™, aimed at improving patient outcomes and lowering healthcare costs. For more details, visit guardanthealth.com.

Guardant Health has partnered with Susan G. Komen to enhance breast cancer care. This collaboration aims to develop clinical studies focusing on high-risk early-stage breast cancer patients, utilizing Guardant Reveal™, a blood test for detecting minimal residual disease (MRD). By integrating input from patient advocates, the partnership seeks to create patient-centric research that informs treatment strategies. The initiative aligns with the goal of improving outcomes through personalized cancer monitoring and therapy.

Guardant Health reported promising results from the ECLIPSE study, demonstrating an 83% sensitivity and 90% specificity in detecting colorectal cancer (CRC) using its blood test. The study involved over 20,000 patients and provides a pathway for a potential FDA approval and Medicare reimbursement. Additionally, the test showed a significant increase in screening adherence, with 90% of patients completing the test compared to 43%-66% for stool tests. Guardant plans to file for premarket approval in Q1 2023.

Guardant Health has announced a collaboration with AstraZeneca to develop the Guardant360 CDx blood test as a companion diagnostic for ESR1-mutated metastatic breast cancer. This initiative is part of a strategic partnership to leverage liquid biopsy for early therapy interventions. The Guardant360 CDx test will identify patients with detectable ESR1 mutations during the SERENA-6 phase III clinical trial, evaluating camizestrant. The collaboration aims to improve patient outcomes through early detection and intervention.

Guardant Health (Nasdaq: GH) has announced that new data from its blood tests will be presented at the 2022 San Antonio Breast Cancer Symposium from December 6-10. The presentations will showcase the Guardant360® blood test and the GuardantINFORM™ dataset, focusing on critical biomarkers and treatment patterns in advanced breast cancer. Guardant aims to demonstrate the utility of its tests in enhancing understanding of biomarker targets and therapy responses, potentially leading to improved patient outcomes.