Guardant Health Stock Price, News & Analysis

Guardant Health (Nasdaq: GH) will report third quarter 2025 financial results after market close on Wednesday, October 29, 2025. Company management will host a webcasted conference call starting at 1:30 p.m. PT / 4:30 p.m. ET. Live audio will be available on the company’s Investors website at www.guardanthealth.com. The webcast will be archived and available for replay after the event.

Guardant Health (NASDAQ:GH) has received FDA approval for its Guardant360 CDx as a companion diagnostic for Eli Lilly's Inluriyo (imlunestrant) in treating advanced breast cancer patients with ESR1 mutations. The diagnostic test helps identify patients with estrogen receptor-positive (ER+), HER2-negative advanced or metastatic breast cancer who may benefit from Inluriyo treatment after endocrine therapy progression.

The approval is significant as ESR1 mutations affect 40% of HR+, HER2- advanced breast cancers. In the Phase 3 EMBER-3 trial, Inluriyo demonstrated a 38% reduction in risk of progression or death compared to endocrine therapy. This marks Guardant360 CDx's sixth FDA-approved companion diagnostic claim and its second indication in breast cancer treatment.

Guardant Health (NASDAQ: GH) and Quest Diagnostics (NYSE: DGX) have announced a strategic collaboration to expand access to Guardant's Shield™ blood-based colorectal cancer screening test across the United States. The Shield test, which is FDA-approved for average-risk adults aged 45 and older, will be available through Quest's extensive network of approximately 650,000 clinician and hospital accounts.

The partnership will enable physicians to order Shield directly through their existing Quest accounts and EHR systems. Patients will have access to blood draws at Quest's 2,000 service centers and 6,000 in-office phlebotomists. The test is expected to launch through Quest in Q1 2026. Shield is currently covered by Medicare and the Veterans Affairs Community Care Network.

Guardant Health (Nasdaq: GH), a leading precision oncology company, has appointed Alex M. Azar II to its board of directors. Azar, the former 24th Secretary of the U.S. Department of Health and Human Services (HHS), brings significant healthcare leadership experience from both public and private sectors.

During his tenure at HHS, Azar oversaw critical agencies including the Centers for Medicare and Medicaid Services, FDA, and CDC. His extensive experience includes serving as President of Lilly USA, LLC, and holding various executive positions. Currently, he serves on multiple boards and advisory positions, including roles at the Aspen Institute, LifeScience Logistics, and Stanford University School of Medicine.

Guardant Health (Nasdaq: GH) has announced a strategic partnership with LabFlorida/SunDx Labs to expand access to Guardant Shield™, the first FDA-approved blood test for colorectal cancer (CRC) screening, to senior living communities. Through this agreement, LabFlorida will be the exclusive distributor for Shield across senior living facilities in Florida.

The partnership aims to address a critical healthcare gap, as up to 71% of assisted living residents are not current with CRC screening. Shield offers a simple blood draw alternative to traditional screening methods, targeting the 1-2 million individuals in senior living communities who are at increased risk of colorectal cancer due to age. The test could significantly improve screening rates for this vulnerable population, where CRC is the second leading cause of cancer-related deaths with a 91% five-year survival rate if detected early.

Guardant Health (Nasdaq: GH) has announced a strategic partnership with PathGroup to expand the reach of its FDA-approved Shield™ blood test for colorectal cancer (CRC) screening. The collaboration will extend Shield's availability to over 250 hospitals and health systems across 25 states, reaching more than 15,000 PathGroup-affiliated physicians.

Shield, the first FDA-approved blood test for CRC primary screening, will be integrated into PathGroup's electronic ordering systems, streamlining the workflow for healthcare providers. The partnership leverages PathGroup's extensive network of phlebotomists and Patient Service Centers, serving over 5 million patients annually. Additionally, PathGroup will provide expertise in immunohistochemistry (IHC) testing for Guardant's comprehensive biomarker testing suite.

Guardant Health (NASDAQ:GH) announced positive clinical validation results for its Shield™ V2 blood test algorithm for colorectal cancer (CRC) screening. The test demonstrated 84% overall sensitivity with 90% specificity for CRC detection. Stage-specific sensitivities were: 62% for stage I, 100% for stage II, 96% for stage III, and 100% for stage IV.

The validation was conducted using an expanded cohort from the 20,000+ person ECLIPSE study. Shield, which recently received NCCN guideline inclusion as the first FDA-approved blood test for primary CRC screening, showed 13% sensitivity in detecting advanced adenomas. The company is also developing a multi-cancer detection test that received FDA Breakthrough Device Designation.

Guardant Health (Nasdaq: GH), a precision oncology company, has announced an upcoming Investor Day scheduled for September 24, 2025, in New York City. The event will begin at 9:00 a.m. ET / 6:00 a.m. PT and will feature presentations from the company's leadership team.

While in-person attendance is by invitation only due to limited capacity, interested parties can access both live and archived webcasts of the presentation through the "Investors" section of Guardant Health's website at www.guardanthealth.com.

Guardant Health (NASDAQ:GH), a precision oncology company, announced its participation in the Morgan Stanley 23rd Annual Global Healthcare Conference in New York. The company's management will engage in a fireside chat on September 8th at 4:05 p.m. ET. Investors can access both live and archived webcasts of the presentation through the investor relations section of Guardant Health's website.