Geneseq Biosciences announces that Melaseq™ Liquid Biopsy for Melanoma Detection has secured NATA approval

Melbourne, Australia - 20 February 2025 - Geneseq Biosciences is proud to announce that Australian Clinical Labs, the Australian licensee of the Melaseq™ test, has received regulatory approval for its licensed product, Melaseq™ Liquid Biopsy as an in-vitro diagnostic (IVD) assay for clinical use as blood-based biomarker of invasive cutaneous melanoma.

This week, Melaseq™ received formal certification from Australia's National Association of Testing Authorities (NATA). This approval is an important milestone in the development timeline of Geneseq's first diagnostic assay. Previously, the test secured NATA approval for solid tissue application to aid in the genomic characterisation of individual skin biopsies. The new certification confirms Melaseq™ as the world's first genomic test to aid in detecting early-stage invasive melanoma, anywhere on the body.

NATA approval is the culmination of a rigorous validation process, ensuring that Melaseq™ meets the highest clinical and analytical standards. Geneseq Biosciences has conducted extensive research, optimised assay development, and validated the test through large-scale clinical studies, testing thousands of samples across multiple clinical settings and countries. This approval underscores the robustness of Melaseq™ in a clinical setting and reinforces its role as a valuable adjunct to existing melanoma diagnostic pathways.

Melaseq™ is a groundbreaking liquid biopsy test designed to facilitate the early and accurate detection of cutaneous melanoma, one of the most aggressive forms of skin cancer. By analysing specific genetic markers associated with melanoma in a simple blood sample, Melaseq™ is intended to be used in conjunction with standard-of-care diagnostic procedures. It may alert patients to the presence of an invasive melanoma, which can then be confirmed by skin examination and biopsy, ensuring timely and appropriate clinical intervention.

"This approval represents the culmination of a six-year journey from a self-funded concept to a fully certified, diagnostic assay approved for clinical use," said Dr Ryan Van Laar, PhD, CEO of Geneseq Biosciences. "The path to regulatory approval has been both challenging and rewarding, and we are incredibly proud to see Melaseq™ reach this pivotal stage. With NATA certification granted to Australian Clinical Labs, we are now positioned to support the clinical implementation of this cutting-edge liquid biopsy technology, providing a powerful new tool for the early detection of melanoma."

With Melaseq™ now approved for clinical use as a blood-based test, Geneseq Biosciences is committed to broadening its accessibility and clinical adoption. The global liquid biopsy market is rapidly expanding, driven by the demand for minimally invasive cancer diagnostics, and Melaseq™ represents a first-in-class, evidence-backed solution for early melanoma detection.

Within Australia, clinical availability of the Melaseq™ assay will be coordinated by Australian Clinical Labs, who will provide detailed information regarding the timing and process in due course via: https://www.clinicallabs.com.au/melaseq/

Geneseq Biosciences remains dedicated to advancing precision oncology through ongoing research and strategic collaborations. For more information on clinical implementation and partnership opportunities, please contact us via www.geneseq.com.au or info@geneseq.com.au

About Geneseq Biosciences:

Geneseq Biosciences is a Melbourne, Australian based leader in genomic-based liquid biopsy solutions, specialising in advanced molecular diagnostics for oncology applications. By leveraging international experience in genomic test development, cutting-edge laboratory technologies and advanced machine learning analytics, Geneseq is committed to transforming cancer detection and patient care.

For more information, please visit www.geneseq.com.au .