By Fineline Cube 
Burning Rock Ltd. (NASDAQ: BNR), a China‑based medical‑technology company, announced that its OncoGuide OncoScreen Plus CDx System has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW). The companion diagnostic, built on Burning Rock’s proprietary OncoScreen Plus platform, is now cleared to guide clinical selection for AstraZeneca (AZ; NASDAQ: AZN)’s AKT inhibitor capivasertib in hormone‑receptor‑positive, HER2‑negative breast‑cancer patients.
Approval Scope
- Target Population – Adults with HR⁺/HER2⁻ locally advanced or metastatic breast cancer who have progressed after ≥ 1 endocrine therapy in the metastatic setting, or who have recurred within 12 months of completing adjuvant therapy.
- Genetic Markers – The kit simultaneously detects PIK3CA, AKT1, and PTEN alterations, the three biomarkers that predict eligibility for capivasertib plus fulvestrant.
- Single‑Assay Advantage – By consolidating the three companion‑diagnostic targets into one test, OncoGuide OncoScreen Plus reduces turnaround time and workflow complexity for clinicians.
Clinical Context
- Capivasertib is a first‑in‑class, highly selective inhibitor of the AKT1/2/3 kinases, developed by AstraZeneca in partnership with Astex Therapeutics, the Institute of Cancer Research, and Cancer Research Technology Ltd.
- The drug targets the PI3K‑AKT‑mTOR signaling axis, a pathway frequently dysregulated in HR⁺/HER2⁻ breast cancer through PIK3CA, AKT1, or PTEN alterations.
- Capivasertib received U.S. FDA approval in November 2023 and Chinese approval in April 2025, positioning it as a critical therapeutic option in advanced breast cancer.
Market & Strategic Implications
| Factor | Impact |
|---|---|
| Japanese Market | MHLW approval opens a 30‑million‑patient market in Japan, where precision oncology is expanding rapidly. |
| Diagnostic Ecosystem | OncoGuide OncoScreen Plus complements existing companion‑diagnostic platforms, strengthening Burning Rock’s portfolio and cross‑sell opportunities with AstraZeneca. |
| Revenue Synergy | The approval aligns diagnostic and therapeutic pathways, potentially accelerating reimbursement in Japan and other key markets. |
Future Outlook
- Pipeline Expansion – Burning Rock plans to extend OncoGuide OncoScreen Plus to additional indications, leveraging its multiplexing capability.
- Regulatory Momentum – With approvals in the U.S., China, and now Japan, the company is positioned to pursue global regulatory clearance, including the EU market.
- Commercial Partnerships – The alliance with Riken Genesis and AstraZeneca underscores a collaborative model for bringing precision therapies to patients worldwide.-Fineline Info & Tech