Guardant Health Stock Price, News & Analysis

Guardant Health (NASDAQ: GH) has partnered with actor James Van Der Beek to promote awareness about colorectal cancer (CRC) screening and their FDA-approved Shield blood test. Van Der Beek, who was diagnosed with stage 3 CRC at age 46, is speaking publicly for the first time about the importance of screening.

The Shield blood test, approved by the FDA last year, offers a convenient screening option for adults 45+ at average risk for CRC through a simple blood draw. With CRC being the second most deadly cancer in the U.S., causing over 50,000 deaths annually, early detection is crucial as the five-year survival rate exceeds 90% when caught early but drops to 13% in late stages.

The National Comprehensive Cancer Network has included Shield in its updated CRC screening guidelines, potentially improving patient access. This advancement is significant as more than 50 million Americans avoid traditional screening methods due to their unpleasant or inconvenient nature.

Guardant Health (Nasdaq: GH) announced positive results from the RADIOHEAD study, conducted in collaboration with the Parker Institute for Cancer Immunotherapy (PICI). The study evaluated Guardant Reveal, a tissue-free monitoring tool for detecting immunotherapy responses in advanced cancer patients.

The research, published in Cancer Research Communications, analyzed over 500 patients with various advanced solid tumors. Key findings showed that Guardant Reveal could identify non-responders up to 5 months earlier than standard methods. Patients with ≥80% decrease in tumor fraction showed a 75% lower risk of progression. The study covered multiple cancer types, including lung, skin, head and neck, breast, GI, GU, and gynecologic cancers.

Guardant Health (Nasdaq: GH) announced the enrollment of the first patient in the National Cancer Institute's Vanguard Study, which will evaluate the company's Shield Multi-Cancer Detection (MCD) test. The four-year study aims to enroll up to 24,000 participants aged 45-75 who are cancer-free.

The Shield MCD test, which recently received FDA Breakthrough Device Designation, can screen for 10 different cancer types through a simple blood draw. The test was selected based on its performance in detecting lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver, and gastric cancers. The study's results will inform the design of a larger randomized controlled trial for cancer screening evaluation.

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.