[News Brief] Mirxes Obtains China NMPA Approval for Gastric Cancer Blood Test

Mirxes Obtains China NMPA Approval for Gastric Cancer Blood Test

Mirxes has received regulatory approval from China’s National Medical Products Administration (NMPA) for GASTROClear, a blood-based diagnostic test. The approval allows for gastric cancer screening among high-risk adults aged 45 to 74 within the Chinese market.

  • Clinical Data: The test identifies 12 microRNA markers and demonstrated an 87.5% sensitivity rate for stage 1 gastric cancer during a clinical trial of 9,472 subjects conducted between 2021 and 2023.
  • Market Expansion: Following regulatory clearance, the company plans to triple its Chinese sales team by 2026 and upgrade manufacturing facilities to supply public and private health institutions.
  • Clinical Application: The non-invasive test serves as a screening alternative to gastroscopy for an eligible population estimated at 500 million people under current national health guidelines.

This summary is based on a press release issued by Mirxes.

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