Tokyo and Guangzhou, 25 September 2025 - Riken Genesis Co., Ltd. (Riken Genesis) and Burning Rock Biotech Limited (NASDAQ: BNR, “Burning Rock”) announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca’s capivasertib has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW).

The CDx System is a combination medical device consisting of the OncoGuide™ OncoScreen™ Plus CDx Kit and the OncoGuide™ OncoScreen™ Plus CDx Analysis Program, designed to be used with MGI Tech’s DNBSEQ-G400 sequencing platform. It enables the detection of PIK3CA, AKT1, and PTEN alterations in a single test. This diagnostic tool is intended to guide treatment decisions for adult patients with unresectable or recurrent hormone-receptor (HR)-positive, HER2-negative breast cancer who have progressed following endocrine therapy and whose tumors carry one or more PIK3CA, AKT1, or PTEN gene alterations.

The approval of this CDx system supports the use for patient selection for capivasertib in combination with fulvestrant.

With the introduction of this CDx System into clinical practice, access to precision diagnostics for breast cancer patients in Japan is expected to improve, ultimately expanding therapeutic opportunities. Riken Genesis will begin preparations for insurance coverage, aiming to ensure timely and equitable access for all eligible patients.

Yusheng Han, Founder and CEO of Burning Rock, commented:

"We are delighted to collaborate with Riken Genesis to achieve the approval of the CDx System in Japan. This is a significant milestone in Burning Rock's global strategy. Research shows that this CDx System can assist in guiding clinical treatment for breast cancer, optimizing treatment plans, and enhancing patient outcomes. We are concurrently advancing the product's registration application in China, hoping that its approval there will benefit more breast cancer patients."

Yuko Oi, President and CEO of Riken Genesis, commented: 

"We are honored to receive our first approval for a combination medical device product in partnership with Burning Rock. This achievement represents a promising step toward expanding treatment options for breast cancer patients in Japan. We are committed to delivering this innovative diagnostic tool to patients as quickly as possible."

MGI Tech’s DNBSEQ-G400 is a medium-throughput, next-generation benchtop sequencer. Equipped with a flexible flow cell system, it can support a variety of different sequencing modes, enabling a single-run data output ranging from 55 Gb to1440 Gb. Since the release, DNBSEQ-G400 has been widely used in scientific research, disease control and prevention, environment, and agriculture. By enabling the development of companion diagnostics, the DNBSEQ-G400 exemplifies how MGI's accessible sequencing technology is directly contributing to the advancement of precision medicine and improved clinical care worldwide.

Notes

1 Combination Medical Device:

A combination of two or more types of items (pharmaceuticals, medical devices or regenerative medicines) constituting a medical device to be manufactured and marketed.

2 Companion diagnostics:

Clinical testing performed to predict the efficacy and side effects of drugs before using them for treatment, particularly testing that is performed at the same time as pharmaceutical development.

About OncoGuide^TM OncoScreen^TM Plus CDx System

About Riken Genesis Co., Ltd.

RIKEN GENESIS, founded in October 2007, provides lab-assay services as well as products for genetic testing based on cutting-edge gene analysis technologies and bioinformatics, and has experience in the field of personalized medicine. The company provides highly reliable tests based on international quality standards, as demonstrated by its CLIA certification, being the first organization in Japan to meet this U.S. quality control standard for clinical laboratories.

For more information, please visit: https://www.rikengenesis.jp

About Burning Rock

Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of 1) NGS-based therapy selection testing for late-stage cancer patients, 2) Global pharmaceutical services on biomarker detection and companion diagnostics development, and 3) Early cancer detection which has moved beyond proof-of-concept R&D into the clinical validation stage. Burning Rock provides dedicated services to pharmaceutical partners, encompassing genomic data solutions, clinical trial solutions, precision patient recruitment, and companion diagnostics development and commercialization. Burning Rock has achieved two NMPA-approved IVD kits, four assays with CE marking, and a breakthrough device designation (BDD) received from both US FDA and China NMPA for multi-cancer detection blood test.

For more information about Burning Rock, please visit: https://www.brbiotech.com

About MGI

MGI Tech Co., Ltd. (or its subsidiaries, together referred to as MGI) is committed to building core tools and technologies that drive innovation in life science. Our focus lies in research & development, manufacturing, and sales of instruments, reagents, and related products in the field of life science and biotechnology. We provide real-time, multi-omics, and a full spectrum of digital equipment and systems for precision medicine, agriculture, healthcare, and various other industries.

Founded in 2016, MGI has grown into a leader in life science, serving customers across six continents and establishing research, manufacturing, training, and after-sales service facilities globally. MGI stands out as one of the few companies capable of independently developing and mass-producing clinical-grade gene sequencers with varying throughput capacities, ranging from Gb to Tb levels. With unparalleled expertise, cutting-edge products, and a commitment to global impact, MGI continues to shape the trajectory of life sciences into the future.

For more information, please visit https://en.mgi-tech.com/, LinkedIn, X and YouTube.