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.
TwinStrand Biosciences announced a second Patent Trial and Appeal Board decision upholding all 30 challenged claims of its licensed ’127 patent. The October 14, 2026 final written decision followed a Federal Circuit remand requiring a different legal framework. The board determined that Guardant Health (Nasdaq: GH) had not established that any challenged claim was unpatentable. The University of Washington owns the patent and licenses it exclusively to TwinStrand.
An August 2026 district court judgment preserved a jury verdict against Guardant involving the ’127 and ’631 patents, awarding more than $245.2 million for infringement through May 2026. Guardant must also pay a 6% ongoing royalty on covered products and services through March 2033. A separate re-examination of the ’631 patent remains ongoing.
Guardant Health (GH) presented new colorectal cancer screening data for its Shield blood test at the ACG 2026 Annual Meeting.
A lifetime model of individuals ages 45 to 75 incorporated longitudinal screening adherence and real-world follow-up colonoscopy adherence. Per 1,000 simulated individuals, blood-based screening projected 12 colorectal cancer deaths averted, versus 6 for fecal immunochemical testing (FIT) and 9 for multitarget stool DNA testing (mt-sDNA). Modeled colonoscopies totaled 679, versus 113 and 326, respectively. These are projected outcomes, not observed lifetime results.
A separate Shield implementation study in two rural South Carolina health clinics reported 99% screening adherence.
Guardant Health (GH) received European approval for Guardant360 CDx as a companion diagnostic to identify breast cancer patients who may benefit from ETCAMAH.
The test received CE-marking under Europe’s In Vitro Diagnostic Medical Devices Regulation for patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer. It tests for ESR1 mutations through a blood draw before disease progression, helping guide treatment selection for AstraZeneca’s camizestrant. The European approval follows approvals for the same companion diagnostic use in the United States and Japan. It is the third approval for ETCAMAH and Guardant Health’s 31st companion diagnostic approval.
Guardant Health (GH) will report its third-quarter 2026 financial results after market close on Thursday, November 5, 2026.
Management will host a webcast conference call at 1:30 p.m. Pacific / 4:30 p.m. Eastern. Live audio will be available through the Investors section of the company website, with an archived replay available after the event.
Guardant Health (GH) announced publication of COSMOS-MEL01 results evaluating Guardant Reveal for recurrence monitoring after surgery in stage II–III melanoma.
The prospective, multicenter study analyzed 280 surveillance samples from 48 patients. The blood test detected 81% of distant recurrences during longitudinal surveillance, with 100% specificity in post-treatment samples from patients who remained recurrence-free. Detection of circulating tumor DNA preceded clinical recurrence identification by a median of 70.5 days, with a lead of up to 273 days. Detection of molecular residual disease—cancer signals remaining after treatment—approximately four weeks after surgery was independently associated with approximately 12-fold higher recurrence risk and greater than 30-fold higher death risk.
Guardant Health (GH) will have its FDA-approved Shield blood test for colorectal cancer screening covered under EviCore by Evernorth clinical guidelines effective January 1, 2027.
EviCore, a Cigna-owned specialty benefits manager and the second largest in the U.S., manages medical benefits for payers in more than 23 states. With this policy update, combined with prior coverage from Carelon and UnitedHealth Group, total covered lives for Shield among adults aged 45 and older increase to approximately 94 million, which the company says represents the overwhelming majority of eligible U.S. patients.
Guardant Health (GH) and research collaborators will present 20 abstracts, including one mini oral, on liquid biopsy and methylation-based technologies for lung cancer at the 2026 World Conference on Lung Cancer, held September 12–15, 2026, in Seoul, South Korea.
Presentations cover longitudinal plasma ctDNA profiling with the Guardant INFINITY assay, use of the Guardant Shield blood test to complement low-dose CT screening, plasma ctDNA biomarker analyses from the Phase III FLAURA2 trial, and a machine learning model using Guardant360 data to predict 90‑day brain metastasis risk. Real-world studies evaluate tissue-free MRD testing with Guardant Reveal and plasma ctDNA epigenomic subtyping across Asia-Pacific and the Middle East. The company will also sponsor a one-hour symposium on clinical interpretation of methylation signals in advanced NSCLC.
Guardant Health (GH) has been named to Business Insider’s America’s Most Innovative Businesses 2027 list with a five-star rating. The recognition places Guardant among only 13 biotechnology research companies to receive the top score, based on five years of performance. Criteria included R&D investment relative to revenue, peer perception from an industry survey, and patent growth and volume.
Guardant highlights milestones over the past five years such as delivering 1 million patient tests, building a large AI-powered blood-based data engine, and securing FDA approvals for Shield, described as a leading blood test for primary colorectal cancer screening, and Guardant360 Liquid CDx, the largest FDA-approved liquid biopsy panel. The company reports 29 companion diagnostic approvals for Guardant360 CDx, broad payer coverage for Guardant360 Liquid CDx, rapid growth of the tissue-free Guardant Reveal MRD test, and launch of Shield Multi-Cancer Detection in Asia.
Guardant Health (GH) received FDA approval for its Guardant360® CDx as a companion diagnostic to identify ESR1 mutations in HR-positive, HER2-negative advanced or metastatic breast cancer patients who may benefit from AstraZeneca’s ETCAMAH™ (camizestrant) before radiographic progression.
The approval recommends repeat Guardant360 CDx liquid biopsy testing every three months during therapy for longitudinal ctDNA surveillance. In the Phase III SERENA-6 trial, patients who switched to ETCAMAH plus a CDK4/6 inhibitor after ESR1 mutation detection saw a 56% reduction in risk of disease progression or death and 74% longer median progression-free survival (16.0 vs. 9.2 months), along with a 47% reduction in risk of deterioration in global health status and quality of life.
This marks the first FDA-approved liquid biopsy CDx for longitudinal testing in breast cancer and the 29th CDx indication for Guardant360 CDx across multiple tumor types, supported by broad reimbursement coverage representing more than 300 million covered lives. The company estimates approximately 37,000 women in the U.S. could potentially benefit from this new therapeutic approach.
Guardant Health (Nasdaq: GH) announced that its FDA-approved Shield blood test for colorectal cancer (CRC) screening will be covered under Carelon Healthcare Services’ clinical guidelines effective November 15. Carelon, a major U.S. medical benefit manager and subsidiary of a large health insurer, expands access to Shield for adults 45 and older at average CRC risk.
According to Guardant Health, this policy raises total U.S. covered lives for Shield to about 90 million, or roughly 75% of eligible CRC screening patients. Shield is guideline‑recommended by ACS and NCCN, has over 200,000 real‑world tests performed, and has shown over 90% screening adherence.