Guardant Health (GH) Stock News

Guardant Health (NASDAQ: GH), a precision oncology company, has scheduled its Q2 2025 earnings release for July 30, 2025, after market close. Management will host a conference call at 1:30 PM PT / 4:30 PM ET on the same day.

The earnings webcast will be accessible through the Investors section of Guardant Health's website, with a replay available after the event.

Guardant Health's Shield blood test for colorectal cancer screening has won Fast Company's 2025 World Changing Ideas Award. Shield is the first FDA-approved blood test for primary CRC screening, offering a convenient alternative to traditional colonoscopy and stool tests. The test targets a significant healthcare gap, as one-third of eligible U.S. adults (over 50 million people) skip recommended screening due to the unpleasant nature of current options. The test can be performed through a simple blood draw during routine office visits and is approved for average-risk individuals aged 45 and older. Shield has also received recognition from TIME's Best Inventions 2024, Popular Science's Best of What's New 2024, and is included in NCCN screening guidelines. Colorectal cancer, the second leading cause of cancer deaths in the U.S., has a 91% five-year survival rate when detected early.

Guardant Health (GH) announced results from the LIBERATE study published in ESMO Open, demonstrating the effectiveness of their Guardant Reveal blood test in detecting minimal residual disease in early-stage breast cancer patients. The study analyzed 290 blood samples from 95 patients with ER+/HER2- or triple negative breast cancer. Key findings showed 100% sensitivity for distant recurrence in ER+/HER2- breast cancer patients and 71% overall sensitivity, with 100% specificity and positive predictive value for relapse. The test detected cancer recurrence with a median lead time of 152 days before clinical recurrence. The blood-based test requires no tissue sample and showed nearly 100% sample evaluability. These results build on previous research showing 83% sensitivity for metastatic recurrence in triple negative breast cancer with 99.5% sample-level specificity.

Guardant Health (GH) has received FDA Breakthrough Device designation for its Shield multi-cancer detection (MCD) test, a blood-based screening tool for eight different cancer types in individuals aged 45 or older. The test uses methylation-based technology to detect bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreas cancers. Clinical validation data presented at ASCO 2025 demonstrated impressive performance metrics: 98.6% specificity, 75% overall cancer sensitivity (ranging 62-96% per cancer type), and 92% accuracy in identifying cancer signal origin. The test was also selected by the National Cancer Institute for its Vanguard Study evaluating emerging MCD technology. This FDA designation aims to accelerate development and review processes for devices showing potential in life-threatening disease treatment or diagnosis.

Guardant Health (GH) announced a significant milestone as its Shield blood test has been included in the National Comprehensive Cancer Network's (NCCN) updated colorectal cancer screening guidelines. The Shield test, which detects circulating tumor DNA in blood, is FDA-approved for adults aged 45+ at average cancer risk and is recommended for testing every three years. The inclusion is supported by the landmark ECLIPSE study, published in the New England Journal of Medicine, which demonstrated Shield's 83% sensitivity in detecting colorectal cancer compared to screening colonoscopy. This development represents a major advancement in making colorectal cancer screening more accessible through a simple blood draw alternative.

Guardant Health (GH) announced breakthrough results from the Phase III SERENA-6 trial, showcasing the effectiveness of their Guardant360 CDx liquid biopsy test in detecting early endocrine resistance in breast cancer treatment. The trial demonstrated that using Guardant360 CDx to detect ESR1 mutations and switching patients to AstraZeneca's camizestrant resulted in a 56% reduction in disease progression or death risk in HR-positive breast cancer patients. This groundbreaking study, published in The New England Journal of Medicine, is the first global Phase III trial using ctDNA monitoring to guide therapy changes before radiological disease progression, potentially establishing a new paradigm in breast cancer treatment.

Guardant Health (GH) presented groundbreaking results from the largest molecular residual disease study in colon cancer at ASCO 2025. The study, involving over 2,000 stage III colon cancer patients with 6.1 years median follow-up, demonstrated the effectiveness of their Guardant Reveal blood test in predicting cancer recurrence risk and survival outcomes. The test detected that 62.6% of patients with post-surgical circulating tumor DNA (ctDNA) experienced cancer recurrence within 3 years despite chemotherapy, compared to only 15.4% in patients with undetectable ctDNA. This breakthrough enables better identification of high-risk patients who may need more aggressive treatment, as approximately 30% of stage III colon cancer patients typically relapse after surgery despite standard chemotherapy.

Guardant Health (NASDAQ: GH) has unveiled significant enhancements to its Guardant360® Liquid test, introducing nearly a dozen new smart liquid biopsy applications. The expanded capabilities, powered by the Guardant Infinity™ platform and AI learning engine, enable comprehensive tumor analysis through a simple blood test. Key innovations include: confirming absence of actionable mutations in lung and colorectal cancers, identifying cancer origin for unknown primary sites, classifying breast and lung cancer subtypes through methylation signatures, utilizing pharmacogenomics for therapy safety, detecting HPV and EBV viruses, determining HRD status, and performing HLA genotyping. The test delivers results within seven days and provides molecular profiling information traditionally obtained through tissue-based immunohistochemistry, representing a significant advancement in non-invasive cancer diagnostics.

Guardant Health (GH) will present data from over 19 studies at the 2025 ASCO Annual Meeting, showcasing their liquid biopsy tests' role in cancer care. Key highlights include: 1) A plenary session featuring the Phase 3 SERENA-6 trial demonstrating Guardant360 CDx test's ability to detect ESR1 mutations in breast cancer patients, 2) An oral session presenting the largest study of Guardant Reveal for molecular residual disease detection in colon cancer, involving over 2,000 patients with 6.1 years median follow-up, 3) Validation of an algorithm predicting absence of actionable mutations in colorectal and lung cancers, and 4) Application of epigenomic-based classifier for identifying tumor types in cancer of unknown primary origin. The presentations span various applications including cancer screening, therapy selection, and recurrence monitoring across multiple solid tumor types.