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, Inc. develops precision oncology diagnostics and data products centered on blood and tissue testing for cancer care. Company news commonly covers the Guardant360 liquid biopsy and Guardant360 Tissue franchises, Guardant Reveal for molecular residual disease monitoring, Shield colorectal cancer screening, and InfinityAI real-world data and analytics.
Recurring updates include financial results across Oncology, Screening, and Biopharma & Data revenue categories; FDA companion diagnostic approvals for Guardant360 CDx; research presentations in tumor typing, therapy selection, methylation and multiomic testing; and biopharma collaborations that use Guardant tissue and liquid biopsy assays to support targeted therapy development.
Guardant Health reported a revenue of $78.7 million for Q1 2021, marking a 17% increase year-over-year. The company conducted 18,390 clinical tests, a 21% increase, but biopharmaceutical tests declined by 33%. The launch of Guardant Reveal for colorectal cancer monitoring and the receipt of ADLT status for the Guardant360® test are significant highlights. However, operating expenses rose 93% to $157.8 million, leading to a net loss of $109.7 million. Looking ahead, Guardant expects full-year revenue between $360 million and $370 million, indicating 26%-29% growth.
Guardant Health (Nasdaq: GH) has appointed Craig Eagle, MD, as its new Chief Medical Officer (CMO). Dr. Eagle brings extensive experience in oncology from roles at Genentech and Pfizer, where he led medical affairs and clinical trial operations. His appointment aims to enhance Guardant Health's mission of advancing precision oncology and improving patient access to diagnostics. Dr. Eagle expressed enthusiasm for contributing to innovative cancer care strategies. Guardant Health specializes in liquid biopsy tests that target cancer detection and treatment at various stages.
Guardant Health's Guardant Reveal, a blood-only liquid biopsy, is proven to detect minimal residual disease (MRD) in early-stage colorectal cancer (CRC) patients. In a study from Massachusetts General Hospital, Guardant Reveal demonstrated an industry-leading test sensitivity of 91% by integrating cancer-specific epigenomic signatures and genomic alterations, compared to 40%-50% in traditional tissue-dependent tests. This innovative approach may allow for better prognosis and tailored therapies without the need for tumor tissue.
Guardant Health (Nasdaq: GH), a precision oncology leader, will participate in the BofA Securities 2021 Healthcare Conference. The management team is set to engage in a fireside chat on May 12 at 2:00 p.m. PT / 5:00 p.m. ET. Interested parties can access the live and archived webcast via the company’s website.
Guardant Health focuses on revolutionizing cancer care through proprietary blood tests and advanced analytics. Their innovative tests aid in early detection and treatment of cancer, aiming to improve patient outcomes while reducing healthcare costs.
Guardant Health announces a collaboration with Daiichi Sankyo to seek regulatory approval for the Guardant360 CDx blood test as a companion diagnostic for Enhertu, targeting HER2 mutations in patients with advanced non-small cell lung cancer (NSCLC). This partnership aims to address unmet medical needs, enhancing patient outcomes with personalized medicine. The Guardant360 CDx test, already FDA-approved, offers comprehensive genomic profiling, crucial for guiding treatment decisions across solid tumors.
Guardant Health, Inc. (Nasdaq: GH) will announce its financial results for Q1 2021 on May 6, 2021, after market close. A conference call will follow at 1:30 p.m. PT/4:30 p.m. ET. The audio of the event will be accessible via the company's website and archived for later viewing. As a leader in precision oncology, Guardant Health uses proprietary blood tests to enhance cancer care and outcomes.
Guardant Health (Nasdaq: GH) presents significant findings at the AACR Virtual Annual Meeting, showcasing the effectiveness of its blood tests in precision oncology. Key data support the utility of Guardant360®, Guardant360 CDx, and GuardantOMNI™ in detecting actionable mutations and informing treatment pathways for cancer patients. The Guardant360 CDx has been validated for use with Amgen’s KRAS G12C inhibitor, sotorasib. Notably, the tests demonstrate high concordance with tissue biopsies, enhancing access to critical diagnostics. These advancements aim to improve treatment outcomes, particularly as healthcare recovers from the pandemic.
Guardant Health (Nasdaq: GH) has received approval from the New York State Department of Health for its Guardant Reveal™ liquid biopsy test, designed for detecting and monitoring minimal residual disease (MRD) in early-stage cancer patients. It is the first blood-only test with a 7-day turnaround to assess residual disease status without tissue biopsies. The test focuses initially on early-stage colorectal cancer and demonstrates an industry-leading sensitivity of 91% for detecting circulating tumor DNA (ctDNA). This innovation aims to improve patient management by identifying those who may benefit from adjuvant therapy.
Guardant Health (Nasdaq: GH) has received Advanced Diagnostic Laboratory Test (ADLT) status approval from CMS for its Guardant360 CDx test, the first FDA-approved liquid biopsy for tumor mutation profiling across all solid cancers. This ADLT status indicates that the test meets criteria for innovative products. Effective from January 1, 2022, Medicare will reimburse the test at $5,000 during a nine-month data collection period. This milestone is expected to facilitate broader payer coverage and enhance patient access to comprehensive genomic profiling, improving treatment options for advanced cancer patients.
A study published in JCO Precision Oncology demonstrates that the Guardant360® liquid biopsy test effectively indicates treatment response in patients with metastatic non-small cell lung cancer (mNSCLC) undergoing pembrolizumab-based therapy. In a study involving 51 patients, molecular responders experienced significantly improved progression-free survival (14.1 months) and overall survival (22.1 months) versus non-responders. Guardant Health's test analyzes DNA from blood samples to guide treatment decisions, addressing the need for early indications of therapeutic efficacy.