News & Events

From December 9 to 11, 2025, the "WHO China In Vitro Diagnostic (IVD) Manufacturers' Prequalification (PQ) Workshop", hosted by the World Health Organization (WHO), concluded successfully at The Westin Guangzhou Haizhu Lake. Ms. Harrirt Huang, Vice President of Operations at Gendx, participated in the event. Leveraging the company's mature overseas product portfolio and international compliance foundation, she engaged in in-depth alignment with the top-tier quality standards and global compliance requirements of the IVD industry.

As an authoritative quality endorsement in the global healthcare sector, WHO PQ Certification serves as the "golden passport" for enterprises to access the international market — achieving certification signifies that products meet unified global standards for quality, safety, and performance.

The workshop focused on core topics including the PQ assessment framework, ePQS platform application, technical specifications, on-site production inspections, and change management. It also covered practical sharing on clinical guidelines and market access for priority diagnostic products such as HIV and MTB. Gendx was invited to attend precisely due to the industry-wide recognition of the company's products in relevant fields, which are characterized by high sensitivity, high specificity, and 10-minute rapid detection capability.

As an innovative enterprise with years of profound experience in the molecular diagnostics field,Gendx’s global product layout is steadily maturing. Leveraging solid compliance accumulation and market expansion, the company has paved a high-quality development path aligned with international standards and radiating globally. To date, Gendx’s products have obtained NMPA Certification, CE Certification, EN ISO 13485 Quality Management System Certification, as well as market access qualifications in multiple countries and regions. The company has successfully applied for 46 invention patents, registered 45 trademarks, and filed 5 PCT international patents.

Participation in this WHO Prequalification Workshop is a key practice of Gendx under its "Quality First, Global Layout" strategy. Moving forward, the company will continue to refine its products and services in accordance with international top-tier standards, leverage its existing global compliance foundation and technological advantages to actively pursue PQ Certification, and provide more efficient and high-quality molecular diagnostic solutions for global users, contributing to the advancement of global public health!