Guardant Health, Inc. - GH STOCK NEWS

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.

Guardant Health (Nasdaq: GH) is expanding its Clear Your View campaign to raise awareness for complete biomarker testing in newly diagnosed advanced colorectal cancer (CRC) patients. Despite guidelines recommending testing for six biomarkers, over 60% of patients do not receive complete testing, risking suboptimal therapy. The initiative encourages oncologists to “stop, test, and wait” for testing results to increase treatment efficacy. The campaign is supported by various patient advocacy groups and emphasizes the importance of personalized treatment to improve survival rates.

Guardant Health (Nasdaq: GH) has achieved CE-marking for the Guardant360^® CDx test, which profiles tumor mutations in patients with any solid malignant neoplasm. This test is also approved as a companion diagnostic for non-small cell lung cancer patients with EGFR alterations, indicating suitability for Tagrisso^® (osimertinib) treatment. CE-marking enhances global accessibility of Guardant360 CDx, crucial for guiding personalized cancer treatments based on comprehensive genomic profiling. The test complements Guardant Health's mission to advance precision oncology.

Guardant Health reported a 25% increase in Q4 revenue to $78.3 million and a 34% yearly increase to $286.7 million in 2020. Notably, precision oncology revenue grew 31%, supported by a 70% rise in clinical testing. The company launched Guardant Reveal and expanded its partnership with Vall d’Hebron Institute of Oncology. Despite these gains, operating expenses surged 110% to $141.1 million in Q4, leading to a net loss of $93.7 million. Looking ahead, Guardant expects 2021 revenue between $360 million and $370 million.

Guardant Health (Nasdaq: GH) announces its participation in two upcoming virtual investor conferences. The 10th Annual SVB Leerink Global Healthcare Conference will feature a fireside chat on February 26 at 1:20 p.m. PT. Additionally, the Cowen 41st Annual Health Care Conference will hold a fireside chat on March 2 at 8:10 a.m. PT. Interested parties can access live and archived webcasts on the company’s website. Guardant Health is a leader in precision oncology, focusing on blood tests and advanced analytics to improve cancer patient outcomes and lower healthcare costs.

Guardant Health, Inc. (Nasdaq: GH) will report its fourth quarter and full year 2020 financial results after the market closes on February 24, 2021. A conference call to discuss these results will follow at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time, available for live streaming on the company’s website. Guardant Health is at the forefront of precision oncology, providing proprietary blood tests and advanced analytics to improve cancer care and outcomes. Their tests include Guardant360® and GuardantOMNI®, aiming to enhance early-stage cancer detection and management.