NEW YORK – German firm Oncgnostics said on Thursday that China's National Medical Products Administration approved its DNA methylation-based cervical cancer GynTect assay.
Shanghai-based biotech GeneoDx, a subsidiary of the Sinopharm Group, will distribute the test there under an exclusive license.
The GynTect assay detects cancer-related changes in DNA methylation from cervical smears. It is designed to provide confirmation or identify a predisposition for cervical cancer in patients with abnormal findings, such as a positive HPV test, from a cervical cancer screen.
The Chinese approval follows a multiyear study of approximately 10,000 participants, which Oncgnostics said demonstrated a high sensitivity and specificity.
"Our China partners have done a remarkable job with their elaborate study," Alfred Hansel, Oncgnostics' managing director, said in a statement. "The subsequent approval for the Chinese market is an important milestone for both our partner and our company."
Financial details of the licensing and distribution agreement were not disclosed.