Big news from Nanjing’s innovation community: Geneseeq’s GENESEEQPRIME® high-throughput sequencing kit has officially received FDA approval.

This is more than a regulatory win—it’s a global first.

Triple Certification Milestone

Triple certification: NMPA (China), CE (Europe), and now FDA (U.S.)

The world’s first and only pan-solid tumor high-throughput sequencing panel to achieve all three

Validated across multiple CLIA-certified U.S. labs

From R&D to international rollout, this marks the first time a Nanjing-developed large-panel IVD kit has broken into the core U.S. market. A strong signal of China’s biotech capabilities going global.