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Burning Rock Dx to Seek Chinese Regulatory Approval for NGS Tests as it Eyes Early Cancer Detection

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SAN FRANCISCO (GenomeWeb) – Burning Rock Dx, an oncology-focused Chinese molecular diagnostics company, plans to seek regulatory approvals in its home country for its next-generation sequencing-based tissue and plasma cancer panels as it eyes the early cancer detection market.

The company operates a clinical lab in Guangzhou and also has offices in Beijing and Shanghai, CEO Han Yusheng said. It is collaborating with both Illumina and Agilent to develop cancer diagnostics using those companies' respective sequencing and target enrichment technologies. Currently, the majority of its revenues, about 60 percent, come from its lung cancer products, Han said.

Last summer, Burning Rock received approval from China's National Medical Products Administration for a four-gene lung cancer panel that runs on Illumina's MiSeqDx instrument — the first NGS-based oncology test to be approved in China. The genes — ALK, EGFR, BRAF, and KRAS — were chosen to follow the National Comprehensive Cancer Network's guidelines for molecular testing in lung cancer patients, Han said. The company completed a multicenter validation study of the assay, but the results have not yet been published.

In addition, Han said that the company planned to seek additional NMPA approvals for both larger tissue-based panels as well as circulating tumor DNA-based tests.

Aside from the four-gene panel, the company markets an eight-gene lung cancer panel, as well as a midsized panel of around 168 genes and a larger panel of 520 genes that includes tumor mutational burden and microsatellite instability. Burning Rock offers both pan-cancer and tumor-specific tests for lung, breast, colorectal, prostate, and gynecological cancers as well as hereditary cancer tests to look for cancer predisposition mutations in genes such as BRCA.

The company also sells liquid biopsy assays, including a circulating tumor DNA version of its eight-gene lung cancer test and its 168-gene lung cancer assay. The eight-gene ctDNA assay is geared towards late-stage patients as a substitute for tissue-based diagnostics in cases where a biopsy cannot be done or in patients who have multiple metastases. The assay is used to identify targeted therapies for the patient. The larger ctDNA panel is used primarily to monitor patients, Han said.

The company has published a number of studies with its clinical collaborators in China, including one in 2017 comparing its 168-gene ctDNA assay to the tissue-based version in lung cancer patients, as well as a study last year demonstrating the potential for its eight-gene tissue-based assay as a first-line diagnostic in lung patients in order to guide treatment. It has also published several studies in conjunction with drug trials, using its assays to stratify patients and a study of its colorectal cancer assay for microsatellite instability detection.

Han said that the company plans to seek NMPA approval for additional assays, including a ctDNA assay and larger tissue-based panels. Gaining NMPA approval enables the company to sell the diagnostic as a kit that includes the library prep, sequencing, and bioinformatics, to hospitals to run in their own clinical laboratories. Such a decentralized testing model is attractive for the top 100 or so largest hospitals that have the capacity and technical expertise to bring NGS in house, Han said.

However, he noted, the majority of hospitals continue to want a centralized testing model, where they can order tests that are run in a commercial laboratory. As such, Han said Burning Rock plans to continue to offer its tests both as a service, running them in its own clinical laboratory, as well as to develop kit versions that it would bring through NMPA approval to sell to hospitals.

"I think for at least the next two to three years, that will be the trend," Han added.

In addition, he said that the company's strategy of developing targeted assays that were primarily tumor specific would also help it to gain NMPA approval in the near term.

The company is also looking to expand its R&D efforts into early detection. Earlier this month, the firm raised $126 million in a Series C financing round, which Han said would support those efforts.

For early detection, Han said that the company plans to combine genomic markers with others like epigenomic markers, proteins, and RNA. He said that it presented early data in a poster session at the Chinese Society of Clinical Oncology meeting last year and is currently in the process of writing the paper.

The company is focusing initially on nine cancer types: lung, gastric, colon, breast, ovarian, and liver. Han said the first step would be to target individuals who were at high risk for developing one of those cancer types, due to environmental factors like smoking history. 

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