COMPANY:

Burning Rock Biotech

"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."

"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."

"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)."

"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."

"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."

"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)."

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.

"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..."

"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."

"Burning Rock Biotech...announced a global strategic partnership with IMPACT Therapeutics in companion diagnostics (CDx) development for a pipeline of drugs in the field of synthetic lethality. The two companies will jointly develop CDx for a targeted oncology drug, Senaparib (IMP4297)...for the treatment of prostate cancer globally, including CDx submissions to both the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration of China (NMPA)."

"Burning Rock Biotech Limited...today announced the launch of the PRESCIENT (Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT) study, the first blood-based, pan-cancer early-detection study in China using a multi-omics approach...The study is expected to enroll 11,879 participants across 22 cancer types as well as healthy controls. These 22 cancers account for 88% of cancer incidence and 93% of cancer mortality in China."

"Burning Rock Biotech Limited...today announced a strategic partnership with Abbisko Therapeutics...in companion diagnostics (CDx). The two companies will work together to develop a CDx assay for ABSK091 (formerly known as AZD4547) to advance clinical research and development of the drug. The CDx assay is designed to detect FGFR genetic alterations in patients with urothelial carcinoma."

"Burning Rock Biotech…today announced that its liquid biopsy assay has achieved strong performance in the FDA-led Sequencing Quality Control Phase 2 (SEQC2) study, the results of which have been published on Nature Biotechnology…The ability to diagnose and monitor cancer through circulating-tumor DNA (ctDNA) sequencing promises to revolutionize clinical oncology. Accordingly, there is considerable interest and investment in the ongoing development of NGS-based ctDNA assays. Yet the reliable detection of trace amounts of fragmented ctDNA from a routine blood-draw remains a major technical challenge."

"Burning Rock Biotech...today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx™, a risk stratification test for early stage lung cancer patients, to China...test-identified low-risk patients had a 5-year freedom from recurrence (FFR) rate of 94.6%; test-identified high-risk or intermediate-risk patients who were treated with adjuvant platinum chemotherapy had 96.7% 5-year FFR compared to 71.7% 5-year DFS for high-risk patients who did not receive chemotherapy...'This agreement with Burning Rock accelerates the ongoing expansion of our DetermaRx test to patients and physicians outside the U.S., and exemplifies our global growth strategy.'"

“Burning Rock Biotech Limited…announced that it entered into a development and commercialization agreement with Myriad Genetics, Inc…which will bring myChoice® tumor testing for homologous recombination deficiency, or HRD, to China. The Myriad myChoice CDx test enables physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in potentially increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors…Through the partnership with Myriad, Burning Rock will perform myChoice HRD testing in China for collaborative drug development studies and for clinics.”

"On June 29, 2020, CStone Pharmaceuticals (HKEX: 2616) announced a strategic partnership with Burning Rock Biotech Limited (NASDAQ: BNR) to co-develop and commercialize companion diagnostics (CDx) for pralsetinib, an investigational treatment developed by CStone’s partner Blueprint Medicines, in China for the detection of RET alterations in cancer patients....We are very happy to collaborate with this leading company to leverage our respective advantages in CDx development." "