Guardant Health, Inc.

Guardant Health Applauds New Law Ensuring Access to Colorectal Cancer Screening Innovations with No Cost-Sharing for Pennsylvanians

Pennsylvania enacted HB 1123, aligning insurance coverage for colorectal cancer screening with ACS and NCCN guidelines and eliminating cost-sharing for roughly 2 million screening-eligible Pennsylvanians. The law applies to state-regulated plans and Medicaid, takes effect December 21, 2026, and directly expands access to Guardant Health's Shield blood test. Guardant positions Shield as the most clinically validated CRC blood test and the first included in ACS and NCCN guidelines, so state coverage mandates are a volume tailwind, though the near-term revenue impact of a single state is modest.

•3d ago

Guardant Health Highlights Broad Liquid Biopsy Research Portfolio at ESMO Congress 2026

Guardant Health and its collaborators will present 25 abstracts, including five rapid oral presentations, at the ESMO Congress 2026 in Madrid on October 23-27. The presentations span methylation-based ctDNA monitoring, tissue-free MRD surveillance, and liquid biopsy research across lung, colorectal, and gastric cancers, including the FORTITUDE, PACE-LUNG, and CROWN studies. The release underscores the breadth of Guardant's biopharma, academic, and European public-private partnerships but contains no new clinical data or financial disclosures; treat as a platform-adoption signal rather than a material event.

•12d ago

Guardant Health Shield Blood Test Demonstrates Leading Screening Adherence and CRC Deaths Averted Compared to Stool-Based Tests

Guardant Health presented new modeling and real-world data at ACG 2026 showing its Shield blood test drove 99% screening adherence in rural South Carolina clinics and, per a lifetime simulation, averted more CRC deaths (12 vs. 6 for FIT and 9 for mt-sDNA) per 1,000 individuals. The modeling study found blood-based screening increased, not reduced, colonoscopy volume (679 vs. 113 and 326 per 1,000), countering a key payer concern that blood tests would siphon demand from colonoscopy. The data strengthen Shield's commercial case in medically-underserved populations, though the findings are modeled and meeting-presentation data rather than a regulatory or financial event.

•17d ago

Guardant Health Announces Approval in Europe of Guardant360® CDx as Companion Diagnostic for AstraZeneca’s ETCAMAH™ (camizestrant) in Advanced ER-positive Breast Cancer

Guardant Health received CE-marking in Europe for Guardant360 CDx as a companion diagnostic identifying ER-positive, HER2-negative advanced breast cancer patients who may benefit from AstraZeneca's camizestrant (ETCAMAH). The blood-based test detects ESR1 mutations before disease progression, and the European approval follows earlier companion-diagnostic approvals for the drug in the United States and Japan. This is the company's 31st CDx approval overall, expanding the liquid biopsy platform's commercial reach across major global markets.

•24d ago

Guardant Health COSMOS Study Published in Cancer Research Communications Validates Utility of Guardant Reveal™ Liquid Biopsy Test for Predicting Recurrence in Melanoma

Cancer Research Communications published the COSMOS-MEL01 study, the first prospective multicenter evaluation of Guardant Reveal for MRD detection in resected stage II-III melanoma. The test detected 81% of distant recurrences with 100% post-treatment specificity, and ctDNA detection was associated with roughly 12-fold higher recurrence risk and over 30-fold higher death risk, preceding clinical detection by a median of 70.5 days. The publication extends Guardant Reveal's evidence base into melanoma, supporting broader recurrence-monitoring use, though it does not by itself change reimbursement or near-term revenue.

•27d ago

Guardant Health’s Shield Blood Test Covered by EviCore by Evernorth for Colorectal Cancer Screening

Guardant Health's Shield blood test for colorectal cancer screening will be covered under EviCore by Evernorth clinical guidelines effective January 1, 2027. EviCore is a Cigna-owned company and the second largest specialty benefits manager in the country, serving payers including Blue Cross Blue Shield. Combined with recent coverage expansions from Carelon and UnitedHealth Group, total covered lives for Shield now reach approximately 94 million, which management says represents the overwhelming majority of eligible U.S. patients age 45 and older. The new EviCore policy impacts payers across 23 states, and Shield has been used in more than 200,000 real-world tests with reported screening adherence above 90%. The test is the first FDA-approved blood test for primary CRC screening and is recommended in both ACS and NCCN guidelines. Investor takeaway: Shield now has near-universal commercial payer access ahead of the 2027 effective date, supporting a volume ramp, though reimbursement rates were not disclosed.

•1mo ago

Guardant Health and Collaborators to Present 20 Abstracts Highlighting Portfolio of Liquid Biopsy Tests for Early Detection and Ongoing Treatment Management at 2026 World Conference on Lung Cancer

Guardant Health and its research collaborators will present 20 abstracts, including one mini oral, at the 2026 World Conference on Lung Cancer hosted by the IASLC in Seoul, September 12-15, 2026. The data span Guardant's lung cancer portfolio, including tissue-free MRD surveillance with Guardant Reveal, the Guardant Shield blood test as a complement to low-dose CT screening, and plasma ctDNA biomarker analysis from the Phase III FLAURA2 trial in EGFR-mutated NSCLC. Several studies were conducted independently by academic institutions and industry collaborators using Guardant technologies or real-world data, which the company cites as evidence of broad platform adoption across the research community. Chairman and co-CEO Helmy Eltoukky framed the expanded conference presence around the company's methylation-based technology and the InfinityAI platform, and Guardant will also sponsor a clinician symposium on interpreting plasma methylation signals in advanced NSCLC.

•1mo ago

Business Insider Names Guardant Health One of America's Most Innovative Businesses

Guardant Health has been named to Business Insider’s America's Most Innovative Businesses 2027 list, earning a five-star rating in the biotechnology category. The recognition highlights the company's leadership in precision oncology and its sustained R&D investment, including the delivery of over 1 million patient tests. The accolade underscores Guardant's market position and the clinical utility of its portfolio, such as Shield and Guardant360 Liquid CDx.

•1mo ago

Guardant Health Announces Landmark FDA Approval of Guardant360® CDx as Companion Diagnostic for AstraZeneca’s ETCAMAH™ (camizestrant) in Advanced Breast Cancer

The FDA approved Guardant360 CDx as the companion diagnostic for AstraZeneca's ETCAMAH (camizestrant) in HR-positive, HER2-negative advanced or metastatic breast cancer harboring ESR1 mutations, making it the first FDA-approved liquid biopsy CDx for longitudinal testing in breast cancer. The approval is based on the Phase III SERENA-6 trial, where ctDNA-guided switching to camizestrant plus a CDK4/6 inhibitor after ESR1 mutation detection cut the risk of progression or death by 56% and extended median progression-free survival to 16.0 from 9.2 months. The label calls for repeat Guardant360 CDx testing every three months to detect emerging resistance before radiographic progression — a recurring-testing paradigm with a potential U.S. population of approximately 37,000 women. This marks the 29th CDx indication for the Guardant360 CDx platform globally, which already has Medicare and commercial coverage representing more than 300 million covered lives.

•1mo ago

Guardant Health’s Shield Blood Test Covered by Carelon Health Services for Colorectal Cancer Screening

Carelon Healthcare Services will cover Guardant Health’s Shield blood test for colorectal cancer screening starting November 15, significantly expanding access for eligible policyholders. This decision brings total covered lives for Shield to approximately 90 million, or 75% of the eligible U.S. population, marking a major step in commercial adoption. Shield is the first FDA-approved blood test for primary colorectal cancer screening in average-risk adults and has demonstrated over 90% screening adherence in real-world settings.

•2mo ago

Guardant Health Reports Second Quarter 2026 Financial Results and Increases 2026 Revenue Guidance

Guardant Health reported Q2 2026 revenue of $335.0 million, up 44% year-over-year, driven by a 38% increase in Oncology revenue and a 257% surge in Screening revenue to $52.9 million. The company raised its full-year 2026 revenue guidance to $1.34 billion to $1.36 billion, representing growth of 36% to 38%, up from the previous outlook of 32% to 34%. Operational highlights included FDA approval for Guardant360 Liquid CDx and the inclusion of the Shield blood test in American Cancer Society guidelines, alongside securing coverage from UnitedHealth Group.

•3mo ago

Actor and Cancer Advocate Patrick Dempsey Stars in Emotional Tribute Video From Guardant Health Memorializing Those Who Have Lost Their Lives to Colorectal Cancer

Guardant Health launched a new video campaign featuring actor and cancer advocate Patrick Dempsey to promote the Shield blood test for colorectal cancer screening. The initiative highlights that Shield is the only FDA-approved blood test included in both American Cancer Society and National Comprehensive Cancer Network guidelines. Real-world data cited shows that among approximately 200,000 tested patients, Shield achieved a screening completion rate of over 90%.

•3mo ago

UnitedHealth Group Now Covers Guardant Health’s Shield Blood Test for Colorectal Cancer Screening

Guardant Health announced that UnitedHealth Group, the largest commercial insurer in the U.S., now covers its Shield blood test for colorectal cancer screening. The updated policy provides access to more than 100 million total covered lives, including approximately 40 million UHG members aged 45 and older. Shield is the first and only FDA-approved blood test included in both American Cancer Society and NCCN guidelines for average-risk adults.

•4mo ago

Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS®

The FDA approved Guardant Health’s Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s HERNEXEOS, the first targeted therapy for HER2-mutant advanced non-small cell lung cancer. This approval allows the liquid biopsy test to identify patients with specific HER2 mutations eligible for HERNEXEOS treatment, leveraging a simple blood draw instead of invasive tissue biopsy. Guardant360 CDx now holds 27 companion diagnostic indications globally, covering more than 300 million lives under Medicare and commercial payers, reinforcing its position as a leading comprehensive genomic profiling tool.

•4mo ago

Guardant Health and Collaborators to Present 38 Abstracts Highlighting Breadth and Expanded Clinical Utility of Guardant Liquid Biopsy Tests Powered by InfinityAI at 2026 ASCO Annual Meeting

Guardant Health will present 38 abstracts and one oral presentation at the 2026 ASCO Annual Meeting, highlighting the clinical utility of its liquid biopsy portfolio. Key data includes validation of Guardant360 Liquid CDx as a comprehensive pan-cancer companion diagnostic, reinforcing its recent FDA approval as the world’s largest liquid biopsy panel. Additional abstracts cover expanded access to targeted therapies in lung cancer via improved ALK fusion detection and longitudinal performance of the Shield blood test for colorectal cancer screening.

•5mo ago

American Cancer Society Recommends Guardant Health’s Shield Blood Test in Updated Colorectal Cancer Screening Guidelines

Guardant Health’s FDA-approved Shield blood test has been included in the updated American Cancer Society (ACS) Colorectal Cancer Screening Guidelines. The guidelines recommend Shield as a new option for the more than 50 million eligible Americans who are not up to date with screening, particularly those who decline stool-based or visual exams. Shield is now the only FDA-approved blood test included in both ACS and NCCN guidelines, with real-world data showing a 90% completion rate among ~200,000 patients tested.

•5mo ago

FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint

The FDA approved Guardant Health's new Guardant360 Liquid CDx, the largest FDA-approved liquid biopsy panel with a 100x wider genomic footprint than its predecessor. The test integrates genomic and epigenomic insights from a single blood draw, offering several-fold increased sensitivity for ctDNA detection and faster results in as little as seven days. Seven existing companion diagnostic indications for the previous Guardant360 CDx transfer to the new test, covering therapies in non-small cell lung cancer, colorectal cancer, and advanced breast cancer.

•5mo ago

Guardant Health Reports First Quarter 2026 Financial Results and Increases 2026 Revenue Guidance

Guardant Health reported Q1 2026 revenue of $301.7 million, up 48% year-over-year, fueled by strong performance in both Oncology and Screening segments. The company raised its full-year 2026 revenue guidance to $1.30 billion to $1.32 billion, representing growth of 32% to 34%, up from the prior range of $1.25 billion to $1.28 billion. Screening revenue surged to $41.6 million from $5.7 million in the prior year period, driven by approximately 44,000 Shield tests.

•5mo ago

Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations

Guardant Health received FDA approval for its Guardant360 CDx test as a companion diagnostic for Arvinas and Pfizer’s VEPPANU in ER+/HER2- advanced breast cancer. The blood-based test identifies patients with ESR1 mutations eligible for the new PROTAC therapy, representing the third ESR1 companion diagnostic approval for Guardant. This is the 26th companion diagnostic indication for the Guardant360 platform, which now has coverage for over 300 million lives through Medicare and commercial payers.

•5mo ago