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Tencent Cloud Launches EdgeOne Pages Official Version, Strengthening Its End-to-End AI Strategy

Official release follows successful beta with 150,000 users, empowering developers to build and deploy full-stack web applications in minutes

SHENZHEN, China, Dec. 22, 2025 /PRNewswire/ — Tencent Cloud today announced the official launch of its EdgeOne Pages, a pioneering edge-native, full-stack development platform. This launch marks a significant enhancement to Tencent Cloud’s end-to-end AI development and deployment ecosystem. EdgeOne Pages allows developers to rapidly build Web projects without setting up servers, configuring environments, or handling operations, enabling instant deployment and effortless global launch.


Since its beta launch in October 2024, EdgeOne Pages has gained rapid adoption, serving over 150,000 users and facilitating more than one million deployments. Incorporating extensive user feedback, the official version now introduces multiple new capabilities, including metrics and usage analytics, customizable security protection, mainstream SSR full-stack frameworks, one-click KV storage, and AI voice chatbots.

Furthermore, a permanently free tier is available for all users with a one-click activation, offering core benefits such as unmetered website security acceleration traffic and request quotas, platform-level security protection, and unified data monitoring.

The official version of EdgeOne Pages enables users to configure custom security protection policies, including rate limiting, IP blocklist/allowlist, Referer blocklists, User-Agent blocklist/allowlist, and more
The official version of EdgeOne Pages enables users to configure custom security protection policies, including rate limiting, IP blocklist/allowlist, Referer blocklists, User-Agent blocklist/allowlist, and more

In the past, launching web projects globally often faced challenges such as long deployment cycles and slow launch times. For example, many AI tool developers targeting overseas markets face a lengthy process of complex tasks, including architecture planning, server procurement and configuration, frontend and backend setup, integration of user authentication (email verification, third-party login), multi-currency payment integration and callback handling, operations and maintenance, backups, and cross-region acceleration — a timeline often spanning weeks.


Market demands, however, evolve rapidly. Users seeking “basic text-to-image generation” today may request “style customization + batch export” tomorrow. The ability to rapidly develop, deploy, and validate product ideas has become a key competitive advantage for teams expanding globally.

Now, with the official release of EdgeOne Pages, independent developers and small teams can now streamline building, deployment, and operations into a unified process, reducing website launch time from days to minutes.

Build Phase: EdgeOne Pages provides a rich variety of website templates, covering multiple categories such as AI tools, online utilities, SaaS, B2B services, corporate websites, product pages, e-commerce, landing pages, and campaign pages. Through integrated Functions, users can effortless integrate CMS, payments, OAuth, databases, and other third-party services. Leveraging built-in WebSocket and LLM capabilities, users can even build an AI voice chat page rapidly using pre-built templates.

Build an AI voice chat page quickly with EdgeOne Pages
Build an AI voice chat page quickly with EdgeOne Pages

Deployment Phase: EdgeOne’s network of over 3,200 global edge nodes automatically distributes site content to nodes closest to end users, delivering global acceleration and intelligent caching for both static and dynamic content, ensuring stable and consistent performance.

EdgeOne’s global network includes more than 3,200 edge nodes
EdgeOne’s global network includes more than 3,200 edge nodes

Operation Phase: EdgeOne Pages leverages a serverless architecture, eliminating the need to purchase and maintain servers, significantly reducing operational costs. The official version also introduces enhanced data monitoring capabilities, allowing users to view site usage directly in the console and utilize a new analytics dashboard to filter detailed metrics by site and host, enabling continuous performance tracking.

The official version of EdgeOne Pages features enhanced data analytics
The official version of EdgeOne Pages features enhanced data analytics

EdgeOne Pages has now evolved from supporting a single framework to a complete full-stack ecosystem, with native support for mainstream full-stack frameworks including Next.js, Astro, Nuxt, React Router, and SvelteKit. In the EdgeOne Pages template gallery, users can preview templates or deploy them with one click. Developers can also deploy their existing full-stack applications to EdgeOne Pages without modifying project structures.


Deeply integrated into the AI development ecosystem, EdgeOne Pages offers full compatibility with the CodeBuddy IDE, enabling developers to complete full-stack project development in CodeBuddy and deploy with a single click to launch Web projects with global acceleration. Through MCP (Model Context Protocol), EdgeOne Pages seamlessly connects with mainstream AI IDEs such as Cursor and VS Code, further improving development efficiency. The simultaneous update of EdgeOne CLI provides a smoother development and deployment experience for users with different workflows.


Through products such as CodeBuddy and EdgeOne Pages, Tencent Cloud continues to empower developers worldwide. Looking ahead, EdgeOne Pages will keep innovating and evolving, building a new generation of development tools that are more intelligent, more reliable, and more capable.

Learn more and sign up for a free trial to get started: A Better Way to Build Full-stack Web – EdgeOne Pages

About Tencent Cloud:

Tencent Cloud, one of the world’s leading cloud companies, is committed to creating innovative solutions to resolve real-world issues and enabling digital transformation for smart industries. Through our extensive global infrastructure, Tencent Cloud provides businesses across the globe with stable and secure industry-leading cloud products and services, leveraging technological advancements such as cloud computing, Big Data analytics, AI, IoT, and network security. It is our constant mission to meet the needs of industries across the board, including the fields of gaming, media and entertainment, finance, healthcare, property, retail, travel, and transportation.

Young Chinese Runners Stand Out Performers at UTMB Asia, Powered by Outopia


CHIANG MAI, THAILAND – Media OutReach Newswire – 22 December 2025 – At Chiang Mai Thailand by UTMB, Asia’s only UTMB World Series Major, two young Chinese runners gave standout performances. Zhou Kao, a community manager at Outopia, and Luo Qiong, a college student, proved that talent and community support are a recipe for success. Both athletes were supported by Outopia, a trail running brand dedicated to empowering runners to meet their potential.

Luo Qiong after finishing her race at Chiang Mai UTMB
Luo Qiong after finishing her race at Chiang Mai UTMB

Zhou Kao, who balances a full-time role with rigorous training, finished as runner-up in the tough 100K race, clocking 9:51:39. Without a traditional elite background, Zhou credits his success to Outopia’s support. “Outopia understands the reality of committed runners; their encouragement gave me the confidence to push for a podium finish,” he shared.

Luo Qiong, a senior college student, made her international debut with a remarkable two-week back-to-back challenge. After securing second place in the 20K race, she went on to finish in the top 10 in the competitive 50K, earning her spot in the UTMB Finals in 2026. Discovered by Outopia through domestic races, Luo’s rapid progression is fueled by the brand’s financial and coaching support.

These inspiring performances highlight Outopia’s mission to empower everyday athletes with innovative, high-performance gear, while building a community that nurtures potential at all levels. Founded in 2021, Outopia is committed to supporting runners globally, from local community events to international races.

“Seeing young Chinese runners perform at this level globally is incredibly meaningful,” said Rachel Lyu, Head of Sports Marketing at Outopia. “Our mission is to empower all runners to reach their potential”. At the event, Outopia’s pop-up store and shakeout runs further demonstrated the brand’s expanding global presence.

At Chiang Mai Thailand by UTMB, Outopia’s pop-up store and shakeout runs further demonstrated the brand’s expanding global presence, bringing together runners from all over the world. These events showcased Outopia’s growing international appeal and its dedication to community driven growth.
Hashtag: #Outopia

The issuer is solely responsible for the content of this announcement.

About Outopia

Founded by passionate trail runners, Outopia specializes in high-performance, sustainable Merino wool apparel. Its mission is to empower all runners and make the world a better place through trail running. visit more .

Laos Advances National Road 22 Repairs, Nearly Half Completed

Phommi Nanthavong and Leklay Sivilay during road construction inspection. (Picture by FB page ປະຊາຊົນ)

Lao authorities are accelerating repairs on National Road 22 following damage from landslides and heavy rain, with more than 47 percent of the work now completed.

On 19 December, Phommi Nanthavong, Technical Director of the Economic Triangle Development Company Limited, which is responsible for maintaining the road, said repair work is currently focused on the most challenging sections between km 21+300 and km 33, with base preparation underway at km 33.

Authorities reported that repair work from km 31 to km 34 and from km 40 to km 68 has been completed, representing 47.31 percent of the overall project. 

Phommi also confirmed that the damage was caused by continuous heavy rainfall, landslides, and soil erosion rather than regular road use, creating difficulties for heavy trucks and slowing construction progress.

Emergency repairs have so far restored traffic access, and the road is no longer cut off, he added. 

Asphalt paving is expected to begin within two weeks and is scheduled for completion within three to four months. 

Authorities continue to urge drivers to proceed with caution and follow traffic regulations while construction is ongoing.

Huawei’s MoM-based Multi-Agent Collaboration System Empowers Core Networks’ Transitioning to L4 High Stability

SHENZHEN, China, Dec. 22, 2025 /PRNewswire/ — In an increasingly digital era, modern life and economic activities heavily rely on networks. Network stability directly impacts public ‘digital well-being’ and ‘sense of social participation.’ As the brain of the network, the core network must remain stable, since any service interruption can affect tens of millions of users, causing immeasurable societal impact. Huawei’s ICNMaster MDAF solution builds an intelligent high-stability system based on MoM (Mixture of Models), multi-agent collaboration, and network digital twin technologies. It enables proactive risk prevention, rapid fault recovery, and service restoration within minutes, helping global operators accelerate their journey toward L4 high-stability and ensuring service continuity experience.

As 5G and cloud technologies evolve, services become more diversified. Alongside their emergence come software-hardware decoupling, multi-generation coexistence, complex inter-generation APIs, signaling surges, transport network faults, and data center failures, all of which exert greater pressure on operators to maintain carrier-grade reliability of the core network. According to GlobalData statistics, 42% of operators have experienced core network service interruptions in the past three years, with the frequency increasing annually, drawing widespread industry concern. To guide global operators in progressively improving core network reliability, TM Forum has released a core network high-stability assessment standard. Dozens of operators have already participated in evaluations. Core network reliability enhancement has become an industry consensus.

To meet global operators’ demands for core network high stability, Huawei launched the ICNMaster MDAF intelligent high-stability system. Building upon earlier innovations like the “Fault Management Agent” and “Complaint Handling Agent,” it introduces breakthrough technologies: the MoM architecture, multi-agent collaboration, and agent-network digital twin synergy. This enables automated problem closure, reduces incident probability, achieves service recovery in minutes, and empowers core network L4 high stability.

From ‘Single-Model Architecture’ to ‘Multi-Model Architecture’: Compared to traditional single-model architectures, the MoM architecture achieves scenario breakthroughs. It fully integrates the advantages of the fast inference model with the deep reasoning model like DeepSeek. An intelligent model traffic routing framework dynamically allocates tasks: routine, high-frequency events are handled instantly by fast, accurate models, while complex anomalies requiring deep reasoning are assigned to reasoning models. This ensures lightning-fast responses to common issues and deep reasoning for complex faults, achieving optimal efficiency and precision.

From ‘Single-Agent Automation’ to ‘Multi-Agent Collaborative Self-Closure’: Traditional single agents only automate isolated individual scenarios. Multi-agent collaboration technology can orderly unite multiple agents, performing agent orchestration, conflict resolution, and more. Recovery actions are validated through the network digital twin system, ensuring corrective measures are accurate and effective before being applied to the live network, ultimately achieving a self-closing loop of “perception-analysis-decision-execution.”

Huawei’s ICNMaster MDAF MoM-based multi-agent collaborative high-stability solution goes beyond an enhancement; it is a crucial step toward fully autonomous networks. It enables operators to provide not just connectivity, but a future-oriented, resilient, and intelligent digital foundation. It successfully resolves the long-standing conflict between network stability and operational efficiency and marks a fundamental strategic shift in the telecom industry’s operational model from network-centric to user-centric. The ‘Agent + Digital Twin’ collaboration paradigm validated by this system lays a solid technical and practical foundation for realizing fully autonomous driving networks in the future.

SIM Unlocks Career Agility Through Micro-Credentials


SINGAPORE – Media OutReach Newswire – 22 December 2025 – In today’s fast evolving job market, traditional qualifications alone are no longer sufficient to guarantee career longevity. Employers increasingly value agility, digital fluency, and continuous learning qualities that micro credentials deliver in concise, impactful ways.

Why Micro-Credentials Matter

Micro credentials are short, focused courses designed to equip professionals with in demand skills quickly. Unlike full degree programs, they enable learners to upskill or reskill without disrupting their careers. For industries shaped by rapid technological change such as digital marketing, artificial intelligence (AI), cybersecurity, and sustainability, these credentials are becoming essential for staying relevant.

According to the World Economic Forum’s Future of Jobs Report 2025, 39% of workers’ core skills will change by 2030, and 59% of the global workforce will need reskilling to meet evolving demands. This shift, driven by automation, AI, and sustainability imperatives, makes continuous learning a necessity rather than an option.

Micro credentials bridge this gap by offering industry aligned, stackable learning experiences that can be completed in weeks rather than years. Research indicates that employers are 72% more likely to hire candidates with micro credentials, as these certifications validate practical, job ready skills.

SIM’s Commitment to Career Readiness

SIM Global Education (SIM GE) is at the forefront of lifelong learning, responding to the urgent need for professionals to stay competitive in a rapidly changing economy. Through its Centre for Micro-Credentials (CMC), SIM offers a curated portfolio of short, stackable courses designed to deliver future-ready skills in high-demand areas such as digital marketing, AI, cybersecurity, and sustainability.

These programs are industry-aligned and developed in consultation with employers and global education partners to ensure relevance and practical application. Each course provides actionable knowledge that learners can immediately apply in their roles, making them ideal for busy professionals seeking quick, impactful upskilling.

A distinctive feature of SIM’s micro-credential ecosystem is the integration of digital badges. These secure, verifiable credentials contain metadata about the achievement, issuer, and criteria. Learners can showcase these badges on platforms like LinkedIn, signalling to recruiters and employers that they possess specialized expertise in emerging fields. This visibility supports skill-based hiring, a growing trend among organizations seeking demonstrable competencies rather than just academic qualifications.

SIM also emphasizes flexibility and accessibility. Courses are delivered in bite-sized formats, often online or blended, allowing learners to progress at their own pace without disrupting their careers.

The Bottom Line

Micro-credentials represent a strategic shift in preparing for the future of work. As industries evolve rapidly, the ability to adapt, upskill, and demonstrate verified competencies is essential. Degrees provide a foundation, but they often lack the agility to keep pace with emerging technologies.

SIM’s micro-credential programs offer flexibility, relevance, and recognition, enabling professionals to stay competitive in a skills-driven economy. Learners can customize pathways, focus on areas like AI, cybersecurity, or sustainability, and earn digital badges that employers value in skill-based hiring.

Micro-credentials help professionals future-proof their careers, ensuring resilience amid automation and digital transformation. For organizations, they build a workforce that is agile and ready for tomorrow’s challenges.

References:

  1. The Future of Jobs Report 2025 – https://www.weforum.org/publications/the-future-of-jobs-report-2025/in-full/3-skills-outlook/
  2. Micro credentials offer accessible education for evolving workforce – https://dcs.wisc.edu/blog/microcredentials-offer-accessible-education/
  3. World Economic Forum – https://www.linkedin.com/posts/world-economic-forum_skills-gap-reskilling-the-future-of-ugcPost-7283091514723819521-JmZr/
  4. Career Sense & MySIM – https://www.sim.edu.sg/alumni/careersense-mysim
  5. CMC – https://cmc.sim.edu.sg/s/alumni-landing
  6. Digital Badge – https://learn.credly.com/blog/digital-badges-explained-what-why-how-and-when

Hashtag: #SIMGlobalEducation #SIMGE #GlobalEducation #InternationalDegree #CareerReady #FutureSkills

The issuer is solely responsible for the content of this announcement.

About SIM Global Education

SIM Global Education (SIM GE) is a leading private education institution in Singapore and the region. We offer more than 140 academic programmes ranging from diplomas and graduate diploma programmes to bachelor’s and master’s degree programmes with some of the world’s most reputable universities from Australia, Canada, Europe, United Kingdom, and the United States. SIM GE’s cohort is made up of 16,000 full- and part-time students and adult learners, of which approximately 36% are international students hailing from over 50 countries.

SIM GE’s holistic learning approach and culturally diverse learning environment aim to equip students with knowledge, industry skills and employability competencies, as well as a global perspective to succeed as future leaders in a fast-changing, technologically driven world.

For more information on SIM Global Education, visit

Menarini Silicon Biosystems announces PACE trial biomarker analysis results confirming clinical utility of CELLSEARCH® CTC enumeration to guide treatment decisions in a specific metastatic breast cancer subtype

The secondary analysis of the PACE trial highlights the value of counting Circulating Tumor Cells (CTCs) in the blood to help guide treatment escalation or de-escalation in patients with hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer whose disease progressed after treatment with aromatase inhibitors plus CDK4/6 inhibitors. CTC count is a standalone predictive biomarker, independent of clinical risk factors and circulating tumor DNA.

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Dec. 22, 2025 /PRNewswire/ — Menarini Silicon Biosystems, a pioneer of cell-based liquid biopsy technology, announced today the publication in Clinical Cancer Research[1] of the CTC biomarker analysis from the PACE trial, a multicenter phase II clinical study initiated in 2017. The analysis examined whether CTC count could provide prognostic and predictive information in HR+/HER2- metastatic breast cancer patients progressing after first-line treatment. 

203 patients were randomized to receive either endocrine monotherapy or combination therapy consisting of a doublet (endocrine therapy plus a CDK4/6 inhibitor) or a triplet regimen (endocrine therapy plus a CDK4/6 inhibitor and an immune checkpoint inhibitor). Based on their CTC level, patients were classified into two prognostic groups: those with less than 5 CTCs per 7.5 mL of blood, defined as having indolent disease, and those with 5 or more CTCs, defined as having aggressive disease. While no significant difference in progression-free survival was observed between treatment groups in the overall population, patients with aggressive disease (5 or more CTCs) experienced a meaningful reduction in the risk of progression when treated with combination therapies. More specifically, the risk of progression was reduced by 57% in patients receiving doublet therapy and 74% in patients receiving triplet therapy, when compared with endocrine monotherapy.

Lorenzo Gerratana, MD, Associate Professor at the University of Udine and Physician Scientist at IRCCS CRO Aviano (Italy) and first author of the PACE biomarker analysis, said: “This analysis underscores the value of CTC enumeration to identify HR+/HER2- metastatic breast cancer patients more likely to benefit from intensified therapies after disease progression on first-line treatment. Patients with aggressive disease showed improved clinical outcomes with combination therapy, whereas patients with indolent disease did not show a meaningful benefit from treatment escalation compared to monotherapy”. As the biological mechanisms driving resistance to CDK4/6 inhibitors are still not fully understood, there is a clear unmet need for reliable biomarkers to guide treatment decisions following disease progression.

These recent findings are consistent with the results of the STIC trial[2], published in 2024, which showed that treatment decisions guided by CTC counts could differ from physician choice and, when discordant, either led to improved survival outcomes or allowed treatment de-escalation without negatively affecting survival.

“The STIC and PACE trials consistently demonstrate how our CELLSEARCH CTC enumeration can improve patient management in the heterogeneous metastatic breast cancer setting, where both resistance mechanisms and disease progression remain a challenge,” said Fabio Piazzalunga, President of Menarini Silicon Biosystems (MSB). “This test is available for In Vitro Diagnostic Use in Europe and China, and in the U.S. through our CAP/CLIA/ISO 15189 accredited laboratory in Huntingdon Valley, Pa., USA. We are committed to supporting physicians to make more informed decisions, whether to intensify treatment to control disease progression or reduce treatment intensity to preserve quality of life”.

About CELLSEARCH

CELLSEARCH is the only CE-marked, clinically validated, blood test cleared by the FDA for counting CTCs to aid physicians in managing patients with metastatic breast, prostate, and colorectal cancers.

CELLSEARCH CTC Kit is not cleared or approved for use to guide specific treatment decisions.  The clinical data described herein involve an investigational use of the CELLSEARCH system outside its cleared indications, and have not been submitted to or reviewed by any regulatory authority for approval.

For more information on the full intended use and limitations of the CELLSEARCH system, please refer to the Instructions for Use at http://documents.cellsearchctc.com/.

About MSB

Menarini Silicon Biosystems, based in Bologna, Italy, and Huntingdon Valley, Pa., U.S., is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology, and diagnostics company headquartered in Florence, Italy, with more than 17,000 employees in 140 countries.

[1] https://pubmed.ncbi.nlm.nih.gov/40853871/
[2] https://pubmed.ncbi.nlm.nih.gov/37931185/ 

Contact: PAVY Consulting, Linda PAVY, lipavy@pavyconsulting.com 

 

Beko Secures €100 Million Sustainability-Linked Loan from IFC to Drive Global Innovation and Net-Zero Transformation

Beko has secured its first sustainability-linked loan to expand renewable energy capacity, strengthen earthquake resilience, and promote next-generation eco-efficient appliances and diversity, with sustainability targets tied to emission reduction and increased women’s representation.

ISTANBUL, Dec. 22, 2025 /PRNewswire/ — Beko, the leading global home appliance company, has signed a €100 million sustainability-linked loan with IFC, a member of the World Bank Group. Marking Beko’s first sustainability-linked loan, the agreement reinforces the company’s commitment to integrating sustainability across its value chain and driving innovation in energy-efficient technologies.

Barış Alparslan, Beko CFO
Barış Alparslan, Beko CFO

IFC is the world’s largest development institution focused on the private sector in emerging markets. The newly secured financing will facilitate the ongoing operation of Beko’s two solar power plants dedicated to renewable energy use and strengthen six production facilities which will improve resilience against potential earthquake damage. The loan will also accelerate Beko’s global research and development (R&D) into digitalization and the creation of smart, resource-efficient, and health-focused appliances, supporting sustainable living worldwide.

This five-year financing, structured in accordance with the company’s Sustainability-Linked Financing Framework, includes the company’s 2030 targets to reduce greenhouse gas emissions and strengthen gender diversity within the workforce; reflecting IFC’s focus on inclusive and climate-resilient growth.

“The sustainability-linked loan with IFC marks yet another important milestone in our journey toward building a net-zero future,” said Barış Alparslan, Chief Financial Officer of Beko. “By investing in renewable energy, earthquake resilience, and R&D for smarter, more efficient products, we’re strengthening our ability to meet global sustainability expectations while continuing to deliver value to our customers and communities worldwide. Beko is proud to deepen its collaboration with IFC as we scale innovation that respects the world and is respected worldwide.”

“Our investment in Beko underscores the importance of building resilient infrastructure and advancing R&D to ensure the long-term competitiveness and sustainability of the region’s manufacturing sector,” said Ashruf Megahed, IFC Regional Industry Head for Manufacturing, Agribusiness and Services in the Middle East and Central Asia. “By working with leading companies like Beko, we want to drive economic resilience and create jobs, generating positive effects for the wider economy.”

ABOUT BEKO  

Beko is an international home appliance company with a strong global presence, operating through subsidiaries in more than 55 countries with a workforce of over 50,000 employees and production facilities spanning multiple regions—including Europe, Asia, Africa, and the Middle East. Beko has 22 brands owned or used with a limited license (Arçelik, Beko, Whirlpool*, Grundig, Hotpoint, Arctic, Ariston*, Leisure, Indesit, Blomberg, Defy, Dawlance, Hitachi*, Voltas Beko, Singer*, ElektraBregenz, Flavel, Bauknecht, Privileg, Altus, Ignis, Polar). Beko became the largest white goods company in Europe with its market share (based on volumes) and reached a consolidated turnover of 10.6 billion Euros in 2024. Beko’s 28 R&D and Design Centers & Offices across the globe are home to over 2,300 researchers and hold more than 4,500 international registered patent applications to date. The company has achieved the highest score in the S&P Global Corporate Sustainability Assessment (CSA) in the DHP Household Durables industry for the seventh consecutive year (based on the results dated 16 October 2025) and has been included in the Dow Jones Sustainability Indices for the eighth consecutive year.** The company has been recognized as the 17th most sustainable company on TIME Magazine and Statista’s 2025 list of the World’s Most Sustainable Companies. Beko’s vision is ‘Respecting the World, Respected Worldwide.’  

www.bekocorporate.com  

*Licensee limited to certain jurisdictions.  
**The data presented belongs to Arçelik A.Ş., a parent company of Beko.  

lAbout IFC

IFC — a member of the World Bank Group — is the largest global development institution focused on the private sector in emerging markets. We work in more than 100 countries, using our capital, expertise, and influence to create markets and opportunities in developing economies. In fiscal year 2025, IFC committed a record $71.7 billion to private companies and financial institutions, leveraging private sector innovation and investment to help create a world free of poverty on a livable planet.
www.ifc.org

 

 

 

Guardant Health Japan receives regulatory approval of Guardant360® CDx liquid biopsy as companion diagnostic for imlunestrant in metastatic or recurrent breast cancer previously treated with endocrine therapy

Guardant360® CDx is the first companion diagnostic to be approved in Japan to identify ESR1 mutations in patients with hormone receptor-positive, HER2-negative breast cancer for treatment with imlunestrant

TOKYO, Dec. 22, 2025 /PRNewswire/ — Guardant Health Japan Corp. today announced that the Ministry of Health, Labour and Welfare (MHLW) has approved Guardant360® CDx on 23 October 2025 as a companion diagnostic to identify ESR1 mutations in patients with hormone receptor–positive, HER2-negative breast cancer with disease progression following endocrine therapy, for consideration of treatment with imlunestrant. This approval makes Guardant360® CDx comprehensive genomic profiling panel the first blood-based companion diagnostic to be approved in Japan for the detection of ESR1 mutations.

The ESR1 gene encodes the estrogen receptor alpha proteins, one of the key hormone receptors involved in breast cancer. ESR1 mutations are recognized drivers of resistance to aromatase inhibitors, a class of endocrine therapies widely used as first-line treatment in breast cancer. In a randomized multicenter trial, ESR1 mutations were detected approximately 20 to 40% of patients with locally advanced or metastatic breast cancer previously treated with an aromatase inhibitor¹, and it has been reported ESR1 mutation prevalence increased with additional lines of therapy².

This regulatory approval of the Guardant360® CDx test, which identifies ESR1 mutations using a blood sample, is expected to increase targeted treatment options for patients with hormone receptor–positive, HER2-negative breast cancer who have developed resistance to aromatase inhibitors.

Guardant360® CDx was approved by MHLW in March 2022 for comprehensive genomic profiling in patients with advanced solid tumors. The test is approved as a companion diagnostic for multiple cancer drugs approved in Japan. Testing under the national health insurance system is available at cancer genome core hospitals, cancer genome hub hospitals, and affiliated cancer genome medical institutions designated by MHLW. Please refer to Annex A for the list of approved companion diagnostics.

References:

  1. Jhaveri KL, et al. N Engl J Med. 2025; 392(12): 1189-1202. 
  2. Bhave MA, et al. Breast Cancer Res Treat. 2024; 207: 599-609. 

About Guardant360® CDx 

Guardant360® CDx is a liquid biopsy test that uses next generation sequencing to analyse circulating tumour DNA (ctDNA), which is produced when tumours shed small pieces of their genetic material into the bloodstream. The test provides comprehensive genomic profiling results from a simple blood draw, helping oncologists move beyond the limitations of tissue biopsies to obtain clinically relevant information in time to match patients to the optimal personalized treatment.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer*. For more information, please visit https://guardanthealthjapan.com and follow the company on LinkedIn.

The complete portfolio of Guardant Health products may not be available in all regions. 

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

Annex A

List of Approved Companion Diagnostics in Japan

Biomarker

Cancer

Companion Diagnostic

KRAS G12C

Non-small cell
lung cancer
(NSCLC)

sotorasib

ERBB2 (HER2) mutation

trastuzumab deruxtecan 

EGFR exon 20 insertion
mutation

amivantamab-vmjw

ESR1 mutation

Breast cancer

imlunestrant

BRAF  V600E

Colorectal
cancer

encorafenib, binimetinib, and cetuximab

encorafenib and cetuximab

KRAS/NRAS wild-type 

cetuximab 

panitumumab

ERBB2 copy number
alteration (HER2 gene
amplification positive)

trastuzumab and pertuzumab 

Solid tumor

trastuzumab deruxtecan

MSI-High 

Colorectal
cancer

nivolumab

Solid tumor

pembrolizumab

Note: Underlined item has been added with this approval.