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Burning Rock Launches 14K-Patient Trial in China to Validate Early Cancer Detection Test

NEW YORK – Burning Rock has started a 14,000-patient trial called the Pan-Cancer Early Detection Project (PREDICT) to further validate its cell-free DNA early detection technology.

The oncology-focused, Shanghai-based molecular diagnostics firm is working with the Shanghai Zhongshan Hospital and other medical centers to enroll thousands of patients into PREDICT with the goal of validating its cfDNA test in multiple tumor types. The test, which Burning Rock has been developing for four years, is based on its ELSA-seq technology and gauges methylation profiles.

Burning Rock claimed in a statement that in early investigations its test has shown "potential effectiveness," with a sensitivity of 90 percent in detecting liver cancer, 89 percent in colorectal cancer, and 66 percent in lung cancer at 95 percent specificity. The company is working on studying models in additional cancer types.

Cancer is the leading cause of death in China. Five million people are diagnosed with cancer each year, and 3 million die from their diagnosis.

"CfDNA methylation-based tests, due to their high sensitivity and tissue of origin traceability, have emerged as a promising approach for cancer early detection and are currently undergoing clinical validation globally," Jia Fan, president of Shanghai Zhongshan Hospital and lead principal investigator of PREDICT, said in a statement. "Burning Rock's pan-cancer early detection test has demonstrated promising initial results. We look to further refine and validate the test through the PREDICT study."

Burning Rock sells a number of tissue-based and liquid biopsy assays for cancer in China. Its four-gene lung cancer panel, which runs on Illumina's MiSeqDx, received approval from China's National Medical Products Administration in 2018.