Guardant Health - GH STOCK NEWS

Guardant Health (Nasdaq: GH) announced that the Guardant360 Response test is now covered for U.S. Medicare patients with metastatic or inoperable solid tumors undergoing immune checkpoint inhibitor therapy. This coverage allows for monitoring molecular response through circulating tumor DNA (ctDNA) changes, providing early indications of treatment effectiveness. Patients will receive the Guardant360 CDx or LDT test to establish a ctDNA baseline before therapy and a Guardant360 Response test 4 to 10 weeks post-initiation to assess changes. This significant policy expansion follows previous Medicare coverages for other Guardant Health tests, enhancing the company's offerings and supporting oncologists in making informed treatment decisions.

Guardant Health (NASDAQ: GH) announced it will present data from 14 studies at the 2023 AACR Annual Meeting in Orlando, Florida, from April 14-19. The studies focus on the capabilities of the GuardantINFINITY™ platform in precision oncology, particularly through epigenomic analysis and methylation sequencing for biomarker discovery and therapy selection.

Chairman and co-CEO, Helmy Eltoukhy, highlighted that the research demonstrates the importance of understanding the tumor microenvironment. The GuardantINFINITY platform shows advantages in monitoring circulating tumor DNA (ctDNA) with enhanced sensitivity compared to traditional methods. Several studies underscore its potential in minimal residual disease detection and more.

Guardant Health (NASDAQ: GH) supports a study led by The Ohio State University to improve colorectal cancer (CRC) screening in underserved communities. The Guardant Shield blood test will be offered via mobile clinics to individuals aged 45 and older. This initiative aims to address the low CRC screening compliance, especially in areas with higher mortality rates. The Shield test boasts 83% sensitivity for CRC detection and has shown 90% adherence in real-world settings. The project will enroll approximately 300 patients and is aimed at understanding and improving screening attitudes in these communities.

Guardant Health (Nasdaq: GH) has submitted the final module of its premarket approval (PMA) application for the Shield™ blood test designed to screen for colorectal cancer (CRC) to the U.S. Food and Drug Administration (FDA). This application includes data from the ECLIPSE study, which involved over 20,000 patients, indicating an 83% sensitivity and 90% specificity for detecting CRC. Launched in May 2022, the Shield test has shown approximately 90% adherence in real-world scenarios. Guardant aims to enhance cancer screening access, especially in underserved populations, as CRC remains the second leading cause of cancer-related deaths.

Guardant Health, Inc. (NASDAQ: GH) has appointed Musa Tariq to its board of directors, effective March 6. Tariq, currently the CMO of GoFundMe, brings extensive marketing experience from global brands like Airbnb and Ford. His expertise is expected to enhance Guardant's brand and mission to improve cancer detection and patient outcomes. The company focuses on precision oncology, with products like Guardant360 and Guardant Reveal for cancer monitoring and screening. Tariq's addition comes at a crucial time as Guardant continues to advance its innovative offerings in the oncology field.

Guardant Health reported a strong performance in Q4 2022, achieving $126.9 million in revenue, a 17% increase year-over-year. The company conducted 36,000 tests for clinical customers and 8,200 tests for biopharmaceutical clients, corresponding to growth of 41% and 24%, respectively. For the full year, revenue reached $449.5 million, marking a 20% increase. Despite these gains, the net loss for Q4 2022 was $139.9 million, up from $90.9 million in Q4 2021. Looking ahead, Guardant expects 2023 revenue between $525 million to $540 million, signifying an anticipated growth of 17% to 20%.

Guardant Health, a leader in precision oncology, will participate in two upcoming investor conferences. The first is the Citi 2023 Healthcare Services, MedTech, Tools & HCIT Conference in New York City on March 1, 2023, at 3:30 p.m. Eastern Time. The second is the Cowen 43rd Annual Health Care Conference in Boston on March 8, 2023, at 10:30 a.m. Eastern Time. Live and archived webcasts of both presentations will be available on the Guardant Health website. The company aims to improve cancer care through advanced analytics and proprietary tests like Guardant360 and Shield.

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.