NEW YORK (360Dx) – Novacyt today announced regulatory actions by US and Chinese regulators for two of its products.
In the US, the firm has registered its Novaprep HQ+ Orange vial as a class I device with the US Food and Drug Administration. Providers who can qualify the vial for cytology or molecular use in the US can now purchase the product. Novacyt plans to seek a commercialization partner for the Novaprep vial and media system, the company said.
Novacyt also said that the Novaprep system has been approved by the Chinese Food and Drug Administration for non-gynecological cancer testing in China. The technology was previously approved in 2015 by CFDA for cervical cancer screening. The new approval means Novacyt can market the Novaprep system other cancers through its China subsidiary.
"These regulatory approvals expand the marketing and distribution opportunities for the Novaprep platform in cervical cancer screening, which is the largest, and in certain markets, one of the fastest growing cancer screening markets," Novacyt Group CEO Graham Mullis said in a statement. "The additional non-gynecological approval in China for Novaprep brings the technology to multiple new cancer markets and reinforces our direct sales investment in China, which is already giving substantial growth of 100 percent in 2016 and is expected to deliver more in 2017."