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Thai FDA Approval

GeneFirst Receives Thai FDA Approval for Papilloplex® HR-HPV DNA and mRNA Kits

9 June 2026

Approval expands access to GeneFirst's HPV testing portfolio in Thailand and supports the company's continued international growth strategy.


Abingdon, United Kingdom – June 9th 2026


GeneFirst Ltd, a UK-based molecular diagnostics company specialising in cancer screening and oncology testing, is pleased to announce that its Papilloplex® HR-HPV DNA Kit and Papilloplex® HR-HPV mRNA Kit have received regulatory approval from the Thailand Food and Drug Administration (Thai FDA).


The approval represents an important milestone in GeneFirst's international expansion strategy and enables the commercial distribution of both assays within Thailand, one of the largest healthcare markets in Southeast Asia.


The Papilloplex® HR-HPV DNA Kit is designed for the qualitative detection of high-risk human papillomavirus (HR-HPV) genotypes associated with the development of cervical cancer. The Papilloplex® HR-HPV mRNA Kit detects E6/E7 mRNA expression from high-risk HPV genotypes, providing an additional molecular approach for assessing clinically significant HPV infections.

The approvals strengthen GeneFirst's HPV screening portfolio and support the growing demand for accurate, molecular-based cervical cancer screening solutions across the region.


"This approval marks an important achievement for GeneFirst and reflects our commitment to making high-quality molecular diagnostic solutions available to laboratories and healthcare providers worldwide," said Shirly Sheng, Business Development Director of GeneFirst. "Thailand is an important market within Southeast Asia, and we look forward to working closely with our partners to support HPV screening and cervical cancer prevention initiatives in the region."

The approvals also reinforce GeneFirst's ongoing investment in regulatory compliance and clinical evidence generation. The company is currently undertaking a multi-centre international clinical performance study involving leading HPV reference laboratories to support future regulatory activities and international validation requirements.


About Papilloplex® HR-HPV Kits

The Papilloplex® HR-HPV DNA Kit and Papilloplex® HR-HPV mRNA Kit utilise GeneFirst's proprietary Multiplex Probe Amplification (MPA™) technology, enabling multiplex detection of clinically relevant HPV targets with streamlined laboratory workflows and high analytical performance.


About GeneFirst

GeneFirst Ltd is a UK-based molecular diagnostics company focused on advancing cancer screening and oncology testing through innovative molecular technologies. The company develops and manufactures diagnostic solutions that support the early detection, monitoring and management of cancer, helping laboratories and healthcare providers improve patient outcomes.

GeneFirst's portfolio includes HPV screening assays for cervical cancer prevention and next-generation sequencing (NGS) solutions for precision oncology applications. Through its proprietary technologies and commitment to scientific excellence, GeneFirst aims to expand access to high-quality molecular testing and support cancer prevention and personalised medicine initiatives worldwide.


Media Contact

Winnie Wu

Chief Operations Officer

GeneFirst Ltd

Email: winnie.wu@genefirst.com

Website: www.genefirst.com

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