On October 3, 2025, Singlera Genomics and its Thai partner ARTBiotech jointly announced that the ColonAiQ® multi-gene methylation detection kit, a colorectal cancer testing product independently developed by Singlera Genomics, has officially received registration approval from the Thai Food and Drug Administration (FDA) (Registration No.: 68-2-2-1-0010537). This approval marks a key international expansion for ColonAiQ® following its successful registration in Singapore this past April, bringing transformative breakthroughs to the field of colorectal cancer screening and monitoring in Southeast Asia.
ColonAiQ® utilizes multi-gene methylation biomarkers in blood samples combined with fluorescent probe-based quantitative PCR technology to effectively detect colorectal cancer and precancerous lesions, while also monitoring postoperative recurrence risk in stage I-III colorectal cancer patients. Compared with traditional imaging or proteomic methods, this technology leverages the characteristics of circulating tumor DNA (ctDNA) to achieve non-invasive, real-time, and highly sensitive detection, providing a more convenient and precise solution for clinical practice that enhances early cancer diagnosis and postoperative management.
The authoritative certification of ColonAiQ®'s safety and efficacy by the Thai FDA not only demonstrates its technological leadership but also provides strong momentum for Singlera Genomics' expansion in the Southeast Asian market. This approval accumulates valuable experience for subsequent entry into more regional markets, further consolidating ColonAiQ®'s position as an innovative benchmark in the global liquid biopsy field.
Leveraging ARTBiotech's profound resources and channel advantages within the Thai healthcare market, ColonAiQ® will be rapidly deployed in Thai medical institutions, benefiting a broad patient population. Ms. Jutifun Kidchalad, Founder and CEO of ARTBiotech, stated, "Colorectal cancer is one of the most prevalent malignant tumors in Thailand, and early screening is crucial for improving survival rates. ColonAiQ® achieves precise, non-invasive screening with just a single blood draw, which will significantly enhance local prevention and treatment capabilities, propelling Thailand's precision medicine into a new stage."
Mr. Liu Qiang, Co-founder and COO of Singlera Genomics, emphasized: "As a strategic hub in Southeast Asia, Thailand's approval marks a significant milestone in Singlera's global expansion and reaffirms the international value of China's original technologies. Moving forward, we will continue to deepen collaboration with global partners to make innovative technologies accessible to patients worldwide, collectively building a global ecosystem for precision medicine."