FAST NEWS: Burning Rock’s cancer test gets breakthrough designation

The latest: Cancer screening company Burning Rock Biotech Ltd. (BNR.US) announced Sunday that its OverC multi-cancer detection blood test (MCDBT) has been granted breakthrough device designation by the China National Medical Products Administration (NMPA).

Looking up: OverC was previously granted breakthrough device status by the U.S. Food and Drug Administration (FDA) in January. Now, with its similar designation from the NMPA, it has become the only product of its type worldwide to receive breakthrough device status from both the FDA and NMPA.

Take Note: The product has only entered the NMPA’s “special examination and approval procedures for innovative medical products,” and has not been formally approved for commercialization.

Digging Deeper: Founded in 2014 and listed on the Nasdaq in 2020, Burning Rock provides cancer detection and related services through its own centralized laboratories as well as a growing number of laboratories within partner hospitals. Travel restrictions during the pandemic forced some of the company’s laboratories to close, dealing a blow to its business. To increase its revenue sources, it has boosted cooperation with pharmaceutical companies to assist them in screening disease targets for the development of new drugs. In the first quarter of this year, revenue related to that business totaled 29.15 million yuan ($4 million), up 136% year-on-year.

Market Reaction: Burning Rock’s shares jumped 11.9% on Monday to close at $1.13 after the announcement. The stock trades near the lower end of its 52-week range.

Translation by A. Au

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