^
Contact us  to learn more about
our Premium Content:  News alerts, weekly reports and conference planners

COMPANY:
Burning Rock Biotech

i
Other names: Burning Rock Biotech | Burning Rock Dx | Burning Rock Biotech Ltd. | Burning Rock Biotech Ltd | Burning Rock Biotech Limited | Beijing Burning Rock Biotech Limited | Guangzhou Burning Rock Dx Co., Ltd. | Guangzhou Burning Rock Dx Co., Ltd | Guangzhou Burning Rock Dx Co Ltd | Guangzhou Burning Rock Dx Co.,Ltd.
Related tests:
Evidence

News

7ms
Burning Rock and Boehringer Ingelheim Achieved a Master Service Agreement in Oncology Companion Diagnostics (GlobeNewswire)
"Burning Rock Biotech Limited...is pleased to announce that the Company and Boehringer Ingelheim officially have signed the Master Service Agreement (MSA) in the field of oncology companion diagnostics. This agreement aims to provide Chinese patients with safer, more efficient, and precise treatment options and diagnostic methods, thereby promoting innovation and development in cancer treatment. This partnership will primarily focus on advancing the clinical trials related to Boehringer Ingelheim's MDM2-p53 antagonist, brigimadlin (BI 907828), and the development of companion diagnostic products in China."
Licensing / partnership
|
brigimadlin (BI 907828)
7ms
Burning Rock received Breakthrough Device Designation from China’s NMPA for its multi-cancer early detection test (Burning Rock Dx Press Release)
"Burning Rock Biotech Limited...is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA."
Non-US regulatory
|
OverC™
9ms
Burning Rock's minimal residual disease (MRD) product supports advancement in early-stage non-small cell lung cancer treatment, with results published in the Cancer Cell (Burning Rock Dx Press Release)
"Burning Rock Biotech Limited...is delighted to announce that our personalized Minimal Residual Disease (MRD) product, CanCatch® (PROPHETTM panel), was enrolled in a prospective observational study (MEDAL, MEthylation based Dynamic Analysis for Lung cancer, NCT03634826)...In MEDAL-PROPHET study, the CanCatch® demonstrated superior performance in head-to-head comparisons with tumor-agnostic fixed-panel and tumor-informed fixed-panel MRD assays."
Observational data
12ms
Burning Rock's precision oncology diagnostics product supports advancement in late-stage breast cancer treatment, with results published in the New England Journal of Medicine (Burning Rock Dx Press Release)
"Burning Rock Biotech Limited...is pleased to announce that our flagship comprehensive genomic profiling (CGP) product, OncoScreen Plus, was featured in a phase 3 multi-regional clinical trial (MRCT), along with FoundationOneCDx, in support of advancement in breast cancer treatment...In the study, Burning Rock's flagship comprehensive genomic profiling (CGP) product, OncoScreen Plus, was used to determine activating mutations in PIK3CA and AKT1 and inactivating alterations in PTEN genes for patients enrolled in China."
P3 data
|
FoundationOne® CDx • OncoScreen Plus®
over1year
Burning Rock received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test (Burning Rock Dx Press Release)
"Burning Rock...announced that its OverC™ Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally...OverC™ MCDBT is intended for early detection of multiple cancer types (esophageal, liver, lung, ovarian, and pancreatic cancers) in adults of either sex, aged 50-75 years old, at average risk for cancer."
FDA event
|
OverC™
almost2years
MGI Tech, Burning Rock Biotech join forces to develop precision oncology products (Genomeweb)
"Chinese precision oncology firm Burning Rock Biotech and sequencing technology company MGI Tech have partnered to develop precision oncology services and products, the firms said earlier this month..Under the collaboration agreement, Burning Rock will leverage MGI's DNBSeq high-throughput sequencers, including the MGISeq-2000 and DNBSeq-T7, to provide commercial services and develop in vitro diagnostic products, while MGI will offer technical support and services, the companies said."
Licensing / partnership
almost2years
Burning Rock announces the launch of china’s first prospective interventional validation study on multi-cancer early detection - the PREVENT study (Burning Rock Dx Press Release)
"Burning Rock Biotech Limited...announced the launch of the PREVENT (a Prospective multi-canceR Early-detection and interVENTional) study, China’s first prospective interventional study to evaluate the performance of Burning Rock's early cancer detection test, OverC™, in the asymptomatic population. The study is expected to enroll 12,500 asymptomatic individuals, to evaluate the performance of the OverC™ test in detecting 6 cancers (lung, liver, colorectal, esophageal, pancreatic and ovarian cancers)."
Launch
|
OverC™
almost2years
Burning Rock receives CE Mark for its OverC™ Multi-Cancer Detection Blood Test Kit (PRNewswire)
"Burning Rock Biotech Limited...announced that it has received CE marking for its OverC™ Multi-Cancer Detection Blood Test manufactured in both the US and China facilities...The approval of CE mark for the OverC™ test is of much significance for the commercialization and compliance process of Burning Rock's multi-cancer early detection technology and marks a breakthrough in the company's global business strategy."
European regulatory
|
OverC™
2years
Burning Rock secures second NGS kit approval from the NMPA (Burning Rock Dx Press Release)
"Burning Rock Biotech Limited...announced that the National Medical Products Administration (NMPA) approved Burning Rock’s Human Nine-Gene Mutation Joint Detection Kit (reversible termination sequencing) (LungCure™ CDx) as a class III medical device. This approval demonstrates Burning Rock's industry-leading capability of working with the NMPA on bringing an innovative next generation sequencing (NGS)-based diagnostic product to the China market."
Non-US regulatory
|
LungCure™ CDx
2years
Burning Rock to release MRD clinical data on NSCLC and CRC at the upcoming American Association for Cancer Research Annual Meeting (Burning Rock Dx Press Release)
"Burning Rock Biotech Limited...announced that it will present MRD (molecular residual disease) clinical data on non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) at the following two sessions of American Association for Cancer Research (AACR) Annual Meeting on April 8, 2022: 5916 - Tumor-informed patient-specific panel outperforms tumor-naïve and tumor-informed fixed panel for circulating tumor DNA (ctDNA)-based postoperative monitoring of non-small cell lung cancer (NSCLC); and 5917 - Patient-specific tumor-informed circulating tumor DNA (ctDNA) analysis for postoperative monitoring of patients with stages I-III colorectal cancer (CRC)."
Clinical data
over2years
Oncocyte and Burning Rock complete technology transfer part two and prepare for scaled distribution of DetermaRX in China (Oncocyte Press Release)
Oncocyte Corporation...announced the completion of the second part of the technology transfer under its revised Exclusive Sublicense Agreement with Burning Rock Biotech Limited...Per the agreement, Burning Rock has licensed Oncocyte’s proprietary risk stratification DetermaRx™ test in China, and is now poised to launch the test to the world’s largest early-stage lung cancer market.
Launch
|
DetermaRx™
over2years
Merck KGaA, Darmstadt, Germany and Burning Rock Collaborate on Liquid-biopsy Based CDx Development Using Burning Rock’s OncoCompass Target (Burning Rock Dx Press Release)
"Burning Rock Biotech Limited...announced a strategic partnership with Merck KGaA, Darmstadt, Germany, in companion diagnostics (CDx) development for the MET inhibitor tepotinib in the mainland China market. The CDx test is based on Burning Rock's self-developed next generation sequencing (NGS)-based liquid biopsy solution, OncoCompass Target™ panel....Tepotinib was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced non-small cell lung cancer (NSCLC) harboring MET gene alterations..."
Licensing / partnership
|
OncoCompass™ Target
|
Tepmetko (tepotinib)
over2years
Burning Rock Collaborates with IMPACT Therapeutics to Provide Testing Services in Developing IMP9064 in both US and China (GlobeNewswire)
"Burning Rock Biotech Limited...today announced a collaboration with IMPACT Therapeutics where Burning Rock provides testing services in connection with IMPACT Therapeutics’ development of its ATR inhibitor IMP9064, which has received the Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the Phase I/II clinical study, and will begin soon in the U.S. The collaboration will be supported by Burning Rock’s Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited labs in Guangzhou, China and California, U.S."
Licensing / partnership • IND • New P1/2 trial
|
IMP9064