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 has presented promising data for its Shield Multi-Cancer Detection (MCD) test, demonstrating strong performance across 10 cancer types. The blood-based test achieved 98.5% specificity and 60% overall sensitivity, with notably higher sensitivity of 74% for six aggressive cancers including esophageal-gastric, hepatocellular, lung, ovarian, and pancreatic cancers.
Key findings from the blinded case-control study of 778 individuals include:
- 89% accuracy in cancer signal origin prediction
- Sensitivity ranging from 96% (esophageal-gastric) to 21% (prostate)
- Strong performance in detecting aggressive cancers through a simple blood draw
The test's impressive results have led to its selection by the National Cancer Institute for inclusion in their upcoming Vanguard Study. This development represents a significant step forward in early cancer detection technology, potentially offering a new screening option for earlier diagnosis when treatment is more effective.
Guardant Health (Nasdaq: GH) has launched Guardant360 Tissue, a groundbreaking molecular profiling test for tumor tissue that combines comprehensive multiomics analysis. The test, powered by the Guardant Infinity smart liquid biopsy platform, analyzes DNA, RNA, AI-powered PD-L1, and genome-wide methylation data.
Key features include:
- Analysis of 742 DNA genes and fusions in 367 RNA genes
- First tissue comprehensive genomic profiling test with genome-wide tumor methylation analysis
- Requires 40% fewer tissue slides than industry standard
- Results available in under two weeks
- Medicare coverage for eligible patients
The innovative test requires 92% less tissue surface area compared to industry norms, addressing a critical need as over 50% of tumor tissue samples typically fail to meet standard surface area requirements. This advancement enables testing of more patients with tissue samples while providing enhanced insights for therapeutics like PARP-inhibitors and immunotherapies.
Guardant Health (Nasdaq: GH) has launched Guardant360 Tissue, a groundbreaking molecular profiling test for tumor tissue that combines comprehensive multiomics analysis. The test analyzes DNA, RNA, AI-powered PD-L1, and exome-wide methylation data to provide a more complete cancer profile.
Powered by the Guardant Infinity smart liquid biopsy platform, the test examines 742 DNA genes and fusions in 367 RNA genes, while requiring 92% less tissue surface area than industry standards. This efficiency allows testing with 40% fewer slides, enabling more patients to qualify for testing compared to conventional methods where over 50% of samples typically fail surface area requirements.
The advanced test offers enhanced insights for PARP-inhibitors and immunotherapies, while enabling better tumor classification and subtyping. Results are available within two weeks, and the test is covered by Medicare for eligible patients.
Guardant Health (Nasdaq: GH) has announced a strategic collaboration with Pfizer (NYSE: PFE) to advance cancer therapy development using the Guardant Infinity™ smart liquid biopsy platform. The multi-year global partnership will:
- Implement Guardant's liquid biopsy tests in Pfizer's global clinical studies
- Assess circulating tumor DNA (ctDNA) as a surrogate endpoint for therapy response monitoring
- Evaluate blood-based epigenomic analyses
The agreement includes access to Guardant's liquid biopsy tests in China for Pfizer's global clinical trials with Chinese cohorts, building on Guardant's existing partnership with Adicon Holdings announced in July 2022.
Guardant Health (Nasdaq: GH) announced it will present 18 abstracts at the 2025 AACR Annual Meeting in Chicago, including four oral sessions. The presentations will showcase advances in multi-cancer detection and multiomic precision oncology testing powered by their Guardant Infinity smart liquid biopsy platform.
Key highlights include:
- Performance data presentation for the Shield MCD test, selected for the National Cancer Institute's Vanguard Study
- Oral presentations on methylation-based cancer signal identification, lung cancer subtyping, and BRAF mutations analysis in non-small cell lung cancer
- Validation of a new tissue profiling assay with integrated multiomics
- New methylation-based applications for liquid biopsy
The presentations span various cancer types including lung, breast, and colorectal cancers, demonstrating applications in screening, recurrence monitoring, and treatment selection.
Guardant Health (Nasdaq: GH) has scheduled its first quarter 2025 financial results announcement for April 30, 2025, after market close. The precision oncology company will host a conference call and webcast at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on the same day. Investors can access the live audio webcast through the company's website investor section, and a replay will be available after the event.
Guardant Health (Nasdaq: GH) has partnered with Bayshore HealthCare to expand access to precision oncology testing across Canada. The agreement will make Guardant's portfolio of cancer tests available through Bayshore's network of clinics, which serves over 350,000 Canadians annually (excluding Quebec).
The partnership includes three key tests: Guardant360® for therapy selection in advanced cancer, Guardant Reveal™ for minimal residual disease detection and recurrence monitoring in early-stage cancer, and Shield™ blood test for colorectal cancer screening. This collaboration aims to provide physicians with advanced molecular profiling technology for developing personalized care plans and improving patient outcomes.
Guardant Health (Nasdaq: GH) announced that its Shield™ blood test for colorectal cancer screening is now covered by the U.S. Department of Veterans Affairs (VA) Community Care Network. The coverage applies to VA community care beneficiaries aged 45-84 with no copay requirement, marking the first coverage extension beyond Medicare beneficiaries.
The VA network coverage, which serves approximately 9.1 million beneficiaries, follows Medicare's coverage announcement in August 2024. This expansion particularly benefits individuals between 45-64 years old. The Shield blood test, which received FDA approval in July 2024 as the first blood test for primary CRC screening, also recently obtained Advanced Diagnostic Laboratory Test (ADLT) status from CMS.
Guardant Health (Nasdaq: GH) has received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) for its Shield™ blood test for colorectal cancer screening. The test, which received FDA approval in July 2024 as the first blood test for primary CRC screening, will be reimbursed at $1,495 for Medicare patients during the initial nine-month ADLT period starting April 1, 2025.
The ADLT status confirms Shield's innovative nature in providing novel clinical information unavailable through other methods. Following the initial period, Guardant Health will submit private-payer payment data, with the median rate determining Medicare pricing from January 1, 2026, to December 31, 2027. The Shield blood test is approved for primary non-invasive colorectal cancer screening in average-risk individuals age 45 and older.
Guardant Health (Nasdaq: GH) has announced a collaboration with Dak Prescott's Faith Fight Finish Foundation and Partners in Wellness to enhance colorectal cancer screening in Louisiana. The initiative will provide Guardant's Shield™ blood test through mobile screening vans serving over 30 communities in northern and central Louisiana.
The program targets an area with particularly high colorectal cancer rates, with 7 of the 11 highest prevalence areas in the state located in northern Louisiana. The initiative is especially significant as colorectal cancer disproportionately affects African American populations, who represent 59% of Partners in Wellness patients.
Partners in Wellness, operating since 1999, has served more than 20,000 patients and provided over 50,000 screenings at no cost. The program will conduct multiple mobile screening events during March (Colorectal Cancer Awareness Month), offering the Shield blood test regardless of insurance status or ability to pay, with results available in approximately two weeks.