Japan’s Ministry of Health, Labour and Welfare has granted Manufacturing and Marketing Approval to the OncoGuide OncoScreen Plus CDx System to identify PIK3CA, AKT1, and PTEN alterations for use in selecting adults with unresectable or recurrent HR-positive, HER2-negative breast cancer for treatment with capivasertib in combination with fulvestrant. The system, cleared as a combination medical device, pairs an NGS kit with analysis software and is intended for use on FFPE tumor tissue.
The approval formalizes a biomarker-defined entry point for capivasertib in Japan and gives Riken Genesis, the marketing authorization holder, and Burning Rock, the kit’s manufacturer via its Guangzhou subsidiary, a regulated path to deploy a distributed testing solution tied directly to a targeted therapy. By consolidating three AKT-pathway markers in a single run, the CDx reduces the operational friction of sequential single-gene testing and aligns with the biomarker framework used to generate capivasertib’s pivotal data package. Riken Genesis plans to move immediately toward insurance coverage, a practical determinant of adoption in Japan’s hospital-based molecular testing ecosystem.
Strategically, the move is as much about market enablement as it is about diagnostics. For AstraZeneca, a Japan-approved CDx that matches the label-level biomarker definition helps remove a gating factor to uptake and post-marketing evidence generation. For Burning Rock, this is a visible step in expanding beyond China into regulated CDx markets, using a software-plus-kit model that fits health systems looking to localize testing rather than rely exclusively on central labs. For Riken Genesis, it is a way to anchor domestic NGS capacity around an indication-specific assay rather than cede ground to comprehensive genomic profiling tests already entrenched in Japanese oncology practice.
The immediate impact for sites and sponsors is pragmatic. Hospitals with NGS infrastructure can implement a purpose-built assay with standardized bioinformatics, potentially shortening turnaround times and reducing the need for reflex testing when AKT pathway alterations are suspected. CROs and sponsors running Japan components of global trials gain an approved screening tool that harmonizes biomarker definitions across regions, lowering screen-fail risk and regulatory negotiation over laboratory-developed tests. However, reliance on FFPE tissue means biopsy logistics remain a real constraint in the metastatic HR-positive setting, where liquid biopsy-based workflows have gained traction for speed and patient convenience. PTEN assessment by NGS also carries analytical nuances, and labs will need to ensure proficiency as part of onboarding.
Reimbursement and competitive positioning are the next variables. Japan already reimburses certain broad panels that can detect the same alterations; whether clinicians pivot to an indication-specific CDx will depend on pricing, turnaround, and the degree to which payers and institutions prefer drug-linked assays for label compliance. Supply chain and data governance will also be watched, given cross-border manufacturing and the inclusion of analysis software as part of the regulated device. If capivasertib’s Japan label and access infrastructure are fully aligned, the CDx could quickly become the default route to therapy; if not, it will still serve as a standardized screen for ongoing and future AKT-pathway studies.
Key milestones to track include the timing of insurance listing, lab deployment footprint, and any head-to-head operational comparisons with existing panels on turnaround and failure rates. Broader signals to watch are whether Japan’s regulators continue to endorse multi-gene, pathway-defined CDx linked to specific therapies and whether tissue-only approvals give way to paired plasma options to mitigate biopsy bottlenecks.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
