Gene Solutions, a global biotechnology company, and Pangea Laboratory, a CLIA-certified, CAP-accredited Next Generation Sequencing (NGS) leader in validation platforms for Laboratory Developed Tests (LDTs), announced a strategic collaboration to advance U.S. verification and clinical validation of liquid biopsy assays designed for cancer detection, profiling, and monitoring.

Under the agreement, Gene Solutions will provide SOPs, funding, and technical support from its CAP-accredited NGS laboratories in Singapore and Vietnam. Pangea Laboratory will oversee all analytical and clinical validation of Gene Solutions' tests at its U.S. facilities in Irvine, California. The collaboration is to streamline U.S. readiness for Gene Solutions' AI-powered multi-omics liquid biopsy technologies within CLIA/CAP quality systems.

"Through our collaboration with Pangea, we're combining Gene Solutions' AI-driven multi-omics innovation with world-class U.S. validation expertise," said Dr. Hoa Giang, Co-founder and Chief Data Science Officer of Gene Solutions. "Together, we aim to deliver affordable, advanced cancer detection, tumor profiling, and monitoring tools."

The first collaboration phase will prioritize Gene Solutions' two flagship Next Generation Sequencing (NGS) tests, including:

• SPOT-MAS™, an AI-powered Multi Cancer Early Detection (MCED) blood test integrating ctDNA epigenomics, fragmentomics, and genomics to detect early cancer signals in a single 10 mL blood draw. The assay's development and performance have been assessed across 10 major cancer types and 75 subtypes.
•  K-4CARE™, a dual‑function precision oncology assay combining comprehensive genomic and transcriptomic profiling with Molecular Residual Disease (MRD) detection to guide targeted therapy selection and deliver longitudinal ctDNA-MRD monitoring insights.

John Moore, CEO of Pangea Laboratory, added: "Pangea is pleased to support the advancement of SPOT-MAS and K-4CARE in the U.S. market which are complementary to Pangea's Bladder CARE™ assay, for the early detection of Bladder Cancer. Our validation platform is designed specifically for innovative LDTs, and we look forward to helping clinicians and patients benefit from these technologies."