Gene Solutions and Pangea Laboratory Partner to Enhance Cancer Detection

On January 21, 2026, Gene Solutions and Pangea Laboratory announced a significant collaboration aimed at enhancing cancer detection and monitoring in the United States. This partnership focuses on the verification and clinical validation of liquid biopsy assays, which are critical for cancer profiling and monitoring.

Gene Solutions, a biotechnology firm based in Singapore, will provide standard operating procedures (SOPs), funding, and technical support from its CAP-accredited Next Generation Sequencing (NGS) laboratories located in Singapore and Vietnam. Meanwhile, Pangea Laboratory, recognized for its expertise in validation platforms for Laboratory Developed Tests (LDTs), will manage the analytical and clinical validation of Gene Solutions’ tests at its facilities in Irvine, California.

Collaboration Objectives and Benefits

This collaboration seeks to streamline the readiness of Gene Solutions’ AI-powered multi-omics liquid biopsy technologies within CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists) quality systems. Dr. Hoa Giang, Co-founder and Chief Data Science Officer of Gene Solutions, emphasized the importance of this partnership, 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 phase of this collaboration will focus on validating two flagship NGS tests developed by Gene Solutions. These tests are designed to significantly improve cancer detection rates, particularly in patients at elevated risk.

Pangea Laboratory’s Role

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.” Pangea’s validation platform is specifically tailored for innovative LDTs, and the organization anticipates that this partnership will greatly benefit clinicians and patients alike.

Founded in 2014, Pangea Laboratory is a CLIA-certified and CAP-accredited diagnostics company specializing in high-complexity testing and validation services for Next Generation Sequencing and molecular diagnostics. Gene Solutions, established with the mission to make advanced genomic solutions accessible and affordable, has been delivering millions of genetic tests globally since 2017.

For more information on Gene Solutions and Pangea Laboratory, interested parties can visit their respective websites at Pangea Laboratory and Gene Solutions.

It’s important 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 of these tests are intended for professional use only. SPOT-MAS is recommended for adults at higher cancer risk and is intended to complement guideline-recommended screening; it does not detect all cancers.

This announcement also comes in light of recent regulatory changes regarding LDTs. Following the March 31, 2025, federal district court vacatur, the FDA issued a final rule reverting to prior regulatory text, reaffirming the importance of CLIA and CAP oversight for LDT services.