NMPA
Fosun Diagnostics Obtains China Approval for SARS-CoV-2 Antigen Test
The kit detects the SARS-CoV-2 nucleocapsid antigen in nasopharyngeal swabs within seven days of infection for patients with respiratory and fever symptoms.
The company previewed results from studies slated for presentation next month on both its newly launched MRD assay and soon-to-be launched cancer screening test.
Burning Rock Secures Lung Cancer NGS Test Regulatory Approval in China
The LungCure CDx next-gen sequencing kit is the company's second NMPA-approved in vitro diagnostic following a smaller six-gene panel commercialized in 2018.
Qiagen Next-Gen QuantiFeron Tuberculosis Test Gains Chinese Regulatory Approval
The new approval for QuantiFeron-TB Gold Plus adds to prior regulatory approvals in the US and other countries around the world, including CE-IVD marking.
AnPac Bio Developing Multicancer Testing Device Based on Biophysical Properties of Blood Components
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The device uses the Chinese-American company's "cancer differentiation analysis" technology and may enable earlier, more robust cancer detection.