On September 5, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Duality Biologics (Suzhou) Co., Ltd. ("DualityBio") reported that the pivotal Phase 3 trial (NCT06265428) which DualityBio is conducting in China to evaluate trastuzumab pamirtecan (BNT323/DB-1303) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy met its primary endpoint of progression free survival at a pre-specified interim analysis (Press release, BioNTech, SEP 5, 2025, View Source [SID1234655786]).

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Trastuzumab pamirtecan is a next-generation antibody-drug conjugate candidate targeting the cancer cell surface protein Human Epidermal Growth Factor Receptor 2 ("HER2"). The clinical trial compares the candidate to the approved ADC trastuzumab emtansine (T-DM1). Based on the results from the interim analysis which were shared by the Independent Data Monitoring Committee (IDMC) with DualityBio and evaluated by the Blinded Independent Central Review (BICR), DualityBio plans to discuss the next steps with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China regarding the submission of a Biologics License Application (BLA) of trastuzumab pamirtecan.

"This is a milestone in the fruitful collaboration with our colleagues at DualityBio," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. "We believe that trastuzumab pamirtecan is an ADC candidate with enormous potential which makes it an important asset in our global oncology strategy including combinational approaches. It is the first of our late-stage oncology programs to meet its primary endpoint in a pivotal Phase 3 trial and also highlights our commitment to bringing novel oncology treatments with distinct profiles to patients."

"With over 350,000 new cases annually, breast cancer has a high incidence rate in China, making it the second most common malignant tumor among Chinese women," said Global Medical Officer of DualityBio, Dr. Hua Mu. "The positive Phase 3 data and trastuzumab pamirtecan meeting the primary endpoint at the interim analysis indicate the potential of the BNT323/DB-1303 program to become a new treatment option for breast cancer patients. Together with our partner BioNTech, we plan the development of trastuzumab pamirtecan in further tumor types towards BLA application in other regions including the United States and the European Union to maximize its potential for patients around the world."

This is the first positive Phase 3 data readout achieved in BioNTech’s and DualityBio’s strategic collaboration initiated in April 2023. The collaboration aims to accelerate the development of differentiated ADC therapeutics for solid tumors. In January 2024, the partners initiated a global Phase 3 DYNASTY-Breast02 trial program for trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer (DYNASTY-Breast02, NCT06018337) following positive Phase 1/2 safety and efficacy data in patients with HER2-expressing advanced solid tumors. BioNTech holds global commercial rights (excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region), while DualityBio has commercial rights for Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region.

Further information for media: Fact Sheet about BNT323/DB-1303

About Trastuzumab Pamirtecan (BNT323/DB-1303)
Trastuzumab pamirtecan (BNT323/DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2 which was built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates ("DITAC") platform. HER2 is a surface-expressed protein on solid tumors and has been linked to the aggressive growth and spread of cancer cells, making it a potential target for innovative cancer therapeutics. The candidate has exhibited antitumor activity in both HER2-positive and HER2-low tumor models as well as in several solid tumor indications, including patients with breast and endometrial cancers, as well as other advanced solid tumors. Preclinical data and preliminary clinical data for trastuzumab pamirtecan indicate its potential to target HER2 receptors on solid tumors irrespective of expression level with a manageable safety profile and a potentially expanded therapeutic window. Trastuzumab pamirtecan is currently being additionally evaluated in an ongoing Phase 1/2 trial (NCT05150691) in patients with advanced/metastatic solid tumors and in a pivotal Phase 3 trial (DYNASTY-Breast02; NCT06018337) in patients with Hormone Receptor-positive ("HR+") and Human Epidermal Growth Factor Receptor 2 ("HER2")-low, metastatic breast cancer that have progressed on hormone and/or cyclin-dependent kinase 4/6 ("CDK4/6") therapy. The BNT323/DB-1303 program received the Fast Track designation and Breakthrough Therapy designation from the U.S. Food and Drug Administration ("FDA") for the treatment of endometrial cancer in 2023.

About the Phase 3 trial NCT06265428
The Chinese, multi-center, randomized, controlled Phase 3 trial (NCT06265428) assesses the efficacy and safety of trastuzumab pamirtecan compared with trastuzumab emtansine in patients with HER2-positive unresectable or metastatic breast cancer who have been treated with trastuzumab and taxanes. A total of 228 patients were enrolled across 48 trial sites and were randomized 1:1 to receive trastuzumab pamirtecan or T-DM1, respectively. The trial’s primary endpoint is progression-free survival (PFS) as per RECIST 1.1 criteria, evaluated by Blinded Independent Central Review (BICR). Secondary endpoints include overall survival, objective response rate, duration of response, and safety.

On September 5, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Duality Biologics (Suzhou) Co., Ltd. ("DualityBio") reported that the pivotal Phase 3 trial (NCT06265428) which DualityBio is conducting in China to evaluate trastuzumab pamirtecan (BNT323/DB-1303) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy met its primary endpoint of progression free survival at a pre-specified interim analysis (Press release, BioNTech, SEP 5, 2025, View Source [SID1234655786]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Trastuzumab pamirtecan is a next-generation antibody-drug conjugate candidate targeting the cancer cell surface protein Human Epidermal Growth Factor Receptor 2 ("HER2"). The clinical trial compares the candidate to the approved ADC trastuzumab emtansine (T-DM1). Based on the results from the interim analysis which were shared by the Independent Data Monitoring Committee (IDMC) with DualityBio and evaluated by the Blinded Independent Central Review (BICR), DualityBio plans to discuss the next steps with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China regarding the submission of a Biologics License Application (BLA) of trastuzumab pamirtecan.

"This is a milestone in the fruitful collaboration with our colleagues at DualityBio," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. "We believe that trastuzumab pamirtecan is an ADC candidate with enormous potential which makes it an important asset in our global oncology strategy including combinational approaches. It is the first of our late-stage oncology programs to meet its primary endpoint in a pivotal Phase 3 trial and also highlights our commitment to bringing novel oncology treatments with distinct profiles to patients."

"With over 350,000 new cases annually, breast cancer has a high incidence rate in China, making it the second most common malignant tumor among Chinese women," said Global Medical Officer of DualityBio, Dr. Hua Mu. "The positive Phase 3 data and trastuzumab pamirtecan meeting the primary endpoint at the interim analysis indicate the potential of the BNT323/DB-1303 program to become a new treatment option for breast cancer patients. Together with our partner BioNTech, we plan the development of trastuzumab pamirtecan in further tumor types towards BLA application in other regions including the United States and the European Union to maximize its potential for patients around the world."

This is the first positive Phase 3 data readout achieved in BioNTech’s and DualityBio’s strategic collaboration initiated in April 2023. The collaboration aims to accelerate the development of differentiated ADC therapeutics for solid tumors. In January 2024, the partners initiated a global Phase 3 DYNASTY-Breast02 trial program for trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer (DYNASTY-Breast02, NCT06018337) following positive Phase 1/2 safety and efficacy data in patients with HER2-expressing advanced solid tumors. BioNTech holds global commercial rights (excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region), while DualityBio has commercial rights for Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region.

Further information for media: Fact Sheet about BNT323/DB-1303

About Trastuzumab Pamirtecan (BNT323/DB-1303)
Trastuzumab pamirtecan (BNT323/DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2 which was built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates ("DITAC") platform. HER2 is a surface-expressed protein on solid tumors and has been linked to the aggressive growth and spread of cancer cells, making it a potential target for innovative cancer therapeutics. The candidate has exhibited antitumor activity in both HER2-positive and HER2-low tumor models as well as in several solid tumor indications, including patients with breast and endometrial cancers, as well as other advanced solid tumors. Preclinical data and preliminary clinical data for trastuzumab pamirtecan indicate its potential to target HER2 receptors on solid tumors irrespective of expression level with a manageable safety profile and a potentially expanded therapeutic window. Trastuzumab pamirtecan is currently being additionally evaluated in an ongoing Phase 1/2 trial (NCT05150691) in patients with advanced/metastatic solid tumors and in a pivotal Phase 3 trial (DYNASTY-Breast02; NCT06018337) in patients with Hormone Receptor-positive ("HR+") and Human Epidermal Growth Factor Receptor 2 ("HER2")-low, metastatic breast cancer that have progressed on hormone and/or cyclin-dependent kinase 4/6 ("CDK4/6") therapy. The BNT323/DB-1303 program received the Fast Track designation and Breakthrough Therapy designation from the U.S. Food and Drug Administration ("FDA") for the treatment of endometrial cancer in 2023.

About the Phase 3 trial NCT06265428
The Chinese, multi-center, randomized, controlled Phase 3 trial (NCT06265428) assesses the efficacy and safety of trastuzumab pamirtecan compared with trastuzumab emtansine in patients with HER2-positive unresectable or metastatic breast cancer who have been treated with trastuzumab and taxanes. A total of 228 patients were enrolled across 48 trial sites and were randomized 1:1 to receive trastuzumab pamirtecan or T-DM1, respectively. The trial’s primary endpoint is progression-free survival (PFS) as per RECIST 1.1 criteria, evaluated by Blinded Independent Central Review (BICR). Secondary endpoints include overall survival, objective response rate, duration of response, and safety.

On September 5, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the 2025 World Conference on Lung Cancer ("WCLC") taking place on September 6-9, 2025 in Barcelona, Spain, and the Chinese Society of Clinical Oncology ("CSCO") Annual Meeting 2025, taking place on September 10-14, 2025 in Jinan, China (Press release, Hutchison China MediTech, SEP 5, 2025, View Source [SID1234655767]).

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Updated analysis from savolitinib’s SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer ("NSCLC") patients will be presented at WCLC 2025. Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor ("TKI") being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. Details of the WCLC 2025 presentations are as follows:

Abstract title Presenter / Lead author Presentation details

SPONSORED STUDIES
SAVANNAH: Biomarker Concordance and Acquired Resistance in Patients with EGFRm MET-OverExp and / or Amp NSCLC
Christina Baik, University of Washington and Fred Hutchinson Cancer Center, Seattle, USA MA03.03
Mini Oral: New Advances in Circulating Biomarkers
Room 06
Sunday, September 7, 2025
3:15 – 4:30PM CEST
Efficacy and Safety of Savolitinib in Advanced or Metastatic METex14 NSCLC Patients With or Without Prior Immunotherapy
Yongfeng Yu, Shanghai Chest Hospital, Shanghai, China P3.12.48
Poster: Metastatic NSCLC – Targeted Therapy
Tuesday, September 9, 2025
Frontline Treatment Duration in MET-Amplified NSCLC After Third-Generation EGFR-TKI Failure: SACHI Study Insights
Lijuan Chen, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China P3.12.64
Poster: Metastatic NSCLC – Targeted Therapy
Tuesday, September 9, 2025
Osimertinib + Savolitinib in EGFRm Advanced NSCLC With MET Overexp And/Or Amp Post-Progression on Osimertinib: SAVANNAH PROs
Silvia Novello, University of Turin, San Luigi Hospital, Turin, Italy PT2.12.04
ePoster: Metastatic NSCLC – Targeted Therapy
Monday, September 8, 2025

INVESTIGATOR-INITIATED STUDIES
Efficacy and Safety of Surufatinib, Durvalumab in Combined with Chemotherapy as First-line Treatment of Extensive-stage Small-cell Lung Cancer Hui Zhang/ Ying Hu, Beijing Chest Hospital, Beijing, China P3.13.22
Poster: Small Cell Lung Cancer and Neuroendocrine Tumors
Tuesday, September 9, 2025

Clinical data of HMPL-653, a novel, selective and potent CSF-1R inhibitor, from a first-in-human Phase I study in patients with tenosynovial giant cell tumor in China will be presented for the first time at the CSCO Annual Meeting 2025. Details of the CSCO Annual Meeting 2025 presentations are as follows:

Abstract title Presenter / Lead author Presentation details

SPONSORED STUDIES
A first-in-human phase I study of HMPL-653, a CSF-1R inhibitor, in patients with tenosynovial giant cell tumor Xiaohui Niu 25297
Oral Session
Friday, September 12, 2025
15:00 – 15:12PM HKT

INVESTIGATOR-INITIATED STUDIES
Fruquintinib Plus Serplulimab as First-Line Therapy in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (nccRCC): Updated Efficacy and Safety from a Multicenter, Single-Arm Trial Jiwei Huang/ Wei Xue 23258
Oral Session
Thursday, September 11, 2025
16:50 – 17:15PM HKT
Fruquintinib plus camrelizumab combined with paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): updated data from a single-arm, phase II clinical trial Tianzhu Qiu/ Yanhong Gu 23766
Oral Session
Friday, September 12, 2025
11:20 – 12:00 noon HKT
Fruquintinib plus chemotherapy as second-line therapy in metastatic colorectal cancer: a multicenter, open-label, phase II clinical trial Yongshun Chen 22084
Poster Session
Efficacy and Safety of Neoadjuvant Fruquintinib plus Toripalimab and Short-Course Radiotherapy (SCRT) for Locally Advanced Rectal Cancer: Updated Results from a Phase II Clinical Trial Zhiping Li 21915
Abstract
Fruquintinib combined with chemotherapy as first-line treatment for advanced metastatic colorectal cancer: a propensity score‑matched comparison of efficacy between a prospective single-arm cohort and a retrospective observational cohort Fuxiang Zhou 23550
Abstract
Efficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide arm Miaomiao Gou 23591
Abstract
Phase ll Clinical Study of Surufatinib Combined with Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer Miaomiao Gou 23610
Oral Session
Friday, September 12, 2025
16:53 – 16:59PM HKT
A single-arm, Phase Ib/II trial of surufatinib plus KN046 and gemcitabine and nab-paclitaxel as first-line treatment for unresectable advanced pancreatic cancer Wenquan Wang/ Liang Liu 23783
Oral Session
Thursday, September 11, 2025
16:20 – 16:35PM HKT
Updated results of surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trial Dan Cao 22652
Poster Session
Surufatinib in patients with soft tissue myeloma who have failed first-line standard chemotherapy or anlotinib: a multicenter, prospective, two-cohort, phase II clinical study Yuhong Zhou/ Xi Guo P80
Poster Session
Efficacy and Mechanistic Study of the NASCA Regimen (Surufatinib Combined with Camrelizumab, Nab-Paclitaxel, and S‑1) in Advanced Pancreatic Cancer Patients with Liver Metastasis Guanghai Dai/ Ru Jia 22309
Abstract
A Phase II, Single-Arm Study of Surufatinib Combined with Zimberelimab and Nab-Paclitaxel in Patients with Advanced Triple‑Negative Breast Cancer: Data Update Caixia Wang 23679
Abstract
Efficacy and safety of surufatinib combined with gemcitabine, cisplatin and immune checkpoint inhibitor for the treatment of unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Xuetao Shi/ Jingtao Zhong 24133
Abstract
Efficacy and Safety of Surufatinib in Patients with Neuroendocrine Neoplasms: A Multicenter Retrospective Study Jiang Long 24294
Abstract

On September 4, 2025 Ibex Medical Analytics (Ibex), a leader in artificial intelligence (AI)-powered cancer diagnostics, reported it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its HER2 breast cancer biomarker scoring solution (Press release, Ibex Medical Analytics, SEP 4, 2025, View Source [SID1234655784]). Ibex’s fully automated "zero-click" AI-enhanced decision support tool for pathologists efficiently increases the accuracy and consistency of HER2 immunohistochemistry (IHC) scoring, including HER2-low cases. Ibex’s breast HER2 solution was developed and validated by Ibex in collaboration with AstraZeneca and Daiichi Sankyo.

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Using digitized images of HER2 IHC stained breast cancer samples, Ibex’s breast HER2 solution detects invasive tumor cell staining patterns and classifies HER2 expression into four standard scores: 0, 1+, 2+ and 3+ (based on ASCO (Free ASCO Whitepaper)/CAP guidelines). It can assist pathologists in the detection and interpretation of cases with HER2 ultralow expression (defined as IHC 0 with membrane staining present). The AI-powered computational tool automates and optimizes case review with:

"Zero-click" invasive tumor detection (automatically excluding ductal carcinoma in situ)
Automated tumor cell identification and cell staining pattern classification
Editable invasive contours and score recalculation
Visualization of AI findings and cell staining pattern percentages for better understanding of score result
Pathologists supported by Ibex’s breast HER2 solution showed improvement in scoring accuracy and consistency, as demonstrated by two clinical studies; one spanning 14 international cancer centers and an additional multi-reader validation study.

The IVDR certificate was received following a meticulous review process, as required by EU regulations, reflecting trust in the quality, safety and performance of the product. Ibex’s breast HER2 solution has been shown to be exceptionally robust, with high performance across multiple labs, scanners, anti-HER2 antibodies, and patient demographics during IVDR clinical studies:

Improved Accuracy (relative to experts): Pathologists supported by AI demonstrated improved sensitivity, when scoring HER2 0 and 1+ slides (91.2% manual score vs. 97.4% with AI) and overall accuracy for all HER2 scores (77.5% manual score vs. 86.6% with AI).
Increased Consistency: Pathologists’ average inter-observer agreement was significantly higher when assisted by AI (94.1%) than with manual scoring (77.3%), in all slides, and specifically for HER2 0 and 1+ slides (97.2% with AI vs. 87.4% for manual score).
"AI can be a valuable decision support tool, aiding pathologists to improve HER2 scoring accuracy and align more closely with expert breast pathologists, as well as enhancing consistency among pathologists, particularly in challenging cases at the lower end of the HER2 expression spectrum," says Dr. Elena Provenzano, lead breast histopathologist at Cambridge University Hospitals NHS Foundation Trust. "Ibex’s HER2 tool could be extremely valuable in today’s clinical landscape, where there is increasing pressure to identify low-expressing HER2 cases in a more reproducible and objective manner."

Ibex’s HER2 biomarker solution is part of Ibex Breast, an integrated AI solution offering a streamlined diagnostic workflow that detects 54 tissue morphologies in breast H&E slides, which has been widely adopted by leading pathology labs worldwide.2,3 Pathologists can review H&E and IHC-stained slides with AI support, facilitating rapid, consistent and objective diagnosis, scoring, and reporting of breast biopsies and excisions.

"Our AI-powered solutions are designed with pathologists, for pathologists, enabling them to leverage cutting-edge technology to make more confident diagnoses," remarked Dr. Manuela Vecsler, VP of Clinical and Scientific Affairs at Ibex Medical Analytics. "We are thrilled to see our HER2 IHC scoring solution’s high performance during IVDR clinical studies, with pathologists noting its ease of use, confidence boost, and smooth workflow integration—underscoring its real-world diagnostic impact. This certification reaffirms our commitment to providing the most accurate and reliable tools for pathologists, ultimately improving patient care."

On September 4, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a positive clinical readout update assessing the performance of the latest colorectal cancer (CRC) screening algorithm (V2) for its Shield blood test (Press release, Guardant Health, SEP 4, 2025, View Source [SID1234655783]). The study met all primary endpoints and the sensitivity of this new screening algorithm for detecting CRC was 84% with 90% specificity. Sensitivity for detection of stage I CRC was 62%.

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"We are pleased with the performance of the new algorithm in detecting stage I CRCs. Today’s update shows yet again that Shield delivers best-in-class performance," said AmirAli Talasaz, Guardant Health co-CEO. "We will continue to leverage our first mover advantage, rapidly growing database and innovation engine to push Shield to higher levels of performance over time."

The clinical validation of the algorithm was conducted on an expanded cohort of subjects enrolled in the landmark ECLIPSE study. ECLIPSE is a 20,000+ person registrational study evaluating the performance of Shield for detecting CRC in average-risk adults that was published in The New England Journal of Medicine. Sensitivity for early-stage CRC was 62% for stage I and 100% for stage II. Sensitivity was 96% for stage III and 100% for stage IV. Sensitivity in detecting advanced adenomas was 13%.

The National Comprehensive Cancer Network (NCCN) recently updated its CRC Screening Guidelines to add Shield as the first blood test that is FDA approved for primary screening of CRC. Shield has also received numerous awards recognizing its innovation and power to change lives, including Fast Company’s World Changing Ideas, TIME’s list of the Best Inventions of 2024 and was selected as a Grand Award Winner in Popular Science’s Best of What’s New 2024.

Beyond CRC screening, Guardant Health has a pipeline of activities around the Shield platform, including the Shield multi-cancer detection (MCD) test which was recently granted Breakthrough Device Designation by the FDA and included in the National Cancer Institute’s Vanguard study.

Shield is the first and only blood test that has received full FDA approval as a primary screening option for CRC in average-risk adults aged 45 and older and can be ordered by any prescribing healthcare provider. For more information, visit www.ShieldCancerScreen.com.