Gene Solutions and Pangea Laboratory Unite for Cancer Test Validation

Gene Solutions, a prominent global biotechnology firm, has announced a strategic collaboration with Pangea Laboratory, a leader in validation platforms for Laboratory Developed Tests (LDTs). This partnership aims to enhance the verification and clinical validation of liquid biopsy assays specifically designed for cancer detection and monitoring in the United States.

The collaboration, disclosed on January 21, 2026, outlines a comprehensive plan where Gene Solutions will contribute standard operating procedures, funding, and technical support from its CAP-accredited Next Generation Sequencing (NGS) laboratories located in Singapore and Vietnam. Pangea Laboratory will manage all analytical and clinical validation processes at its facilities in Irvine, California.

Advancing Cancer Care through Innovation

The primary goal of this partnership is to facilitate the U.S. readiness for Gene Solutions’ AI-powered multi-omics liquid biopsy technologies within CLIA/CAP quality systems. Dr. Hoa Giang, Co-founder and Chief Data Science Officer of Gene Solutions, emphasized the significance of this collaboration, stating, “Through our collaboration with Pangea, we’re combining Gene Solutions’ AI-driven multi-omics innovation with world-class U.S. validation expertise. Together, we aim to deliver affordable, advanced cancer detection, tumor profiling, and monitoring tools.”

The initial focus will be on two flagship NGS tests developed by Gene Solutions: SPOT-MAS, aimed at multicancer early detection, and K-4CARE, which provides comprehensive tumor profiling with circulating tumor DNA (ctDNA) monitoring.

John Moore, CEO of Pangea Laboratory, expressed enthusiasm about the collaboration, noting, “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 CARETM assay for the early detection of bladder cancer.” He highlighted that their validation platform is tailored specifically for innovative LDTs and underlined the potential benefits for clinicians and patients.

About Gene Solutions and Pangea Laboratory

Founded in 2014, Pangea Laboratory is a CLIA-certified and CAP-accredited diagnostics company specializing in high complexity testing and validation services for innovative assays, including NGS and molecular diagnostics. More information can be found at their official website: https://pangealab.com.

Gene Solutions, headquartered in Singapore, aims to make advanced genomic solutions accessible and affordable. The company leverages multi-omics, NGS, and AI technologies to offer a diverse portfolio, including multicancer early detection with SPOT-MAS and comprehensive tumor profiling with K-TRACK and K-4CARE. Since its establishment, Gene Solutions has delivered millions of genetic tests globally, enhancing cancer care through innovation.

For more details, visit www.genesolutions.com and follow them on LinkedIn and Facebook.

It’s essential to note that some tests may be offered as LDTs in CLIA-certified, CAP-accredited laboratories, with availability varying by state and health system. The results are intended for professional use only. SPOT-MAS is recommended for adults at elevated cancer risk and should complement guideline-recommended screening; it does not detect all cancers.

This announcement comes in light of regulatory changes, including the March 31, 2025, federal district court vacatur, following which the FDA issued a final rule that reverted to prior regulatory text, ensuring that CLIA/CAP oversight continues to apply to LDT services.