NEW YORK (GenomeWeb) – Curetis announced today that its distribution partner in China has submitted the Curetis Unyvero sample-to-answer molecular diagnostics system and an assay cartridge to detect pathogens that cause pneumonia for regulatory approval in the country.
Beijing Clear Biotech filed the Unyvero A50 HPN cartridge with the Chinese National Medical Products Administration, an agency formerly known as the China Food and Drug Administration. The HPN assay is designed for hospitalized patients with pneumonia and analyzes 48 genetic markers in about 5 hours.
Curetis expanded its distribution agreement with BCB in October from five to eight years, contingent on NMPA regulatory approval.
The company noted in a statement that the use of foreign data in submissions to the newly formed NMPA became possible a little more than a year ago, when a new regulation was issued by the Chinese government. The HPN submission was based on data from approximately 1,400 patient samples previously submitted to the US Food and Drug Administration trial and as part of European CE-IVD validation studies, as well as analytical data generated in China.
In addition, Curetis noted that BCB has generated clinical data from several hundred patient samples at a Chinese hospital and intends to collect additional clinical data on the performance of Unyvero HPN in China to potentially augment the submission and support future adoption of the test.
Curetis anticipates initial revenues through BCB in China from commercial sales beginning in 2020.