IRVINE, Calif., Jan. 21, 2026 /PRNewswire/ — Pangea Laboratory, a CLIA-certified, CAP-accredited leader in Next-Generation Sequencing (NGS) and molecular diagnostic validation and innovation, today announced a strategic collaboration with Gene Solutions, a global biotechnology company, to validate AI-driven liquid biopsy assays for use in cancer detection, characterization, and monitoring within CLIA/CAP laboratory settings in the U.S. market. Following successful validation, these assays are expected to be offered as laboratory developed tests (LDTs).
Under this agreement, Pangea Laboratory will leverage its integrated validation platform and regulatory expertise to oversee all analytical and clinical validation activities for Gene Solutions’ innovative multi-omics technologies. Gene Solutions will provide standard operating procedures, funding, and technical support from its CAP-accredited laboratories in Singapore and Vietnam. Following validation, these tests may be performed in accordance with applicable CLIA/CAP requirements at Pangea’s state-of-the-art facility in Irvine, California, bringing advanced cancer detection and monitoring tools closer to U.S. patients.
“Pangea is pleased to support the advancement of SPOT-MAS™ and K-4CARE™ in the U.S. market,” said John Moore, CEO of Pangea Laboratory. “Our mission is to develop and enable next-generation diagnostics that provide patients answers sooner, and these assays are complementary to Pangea‘s Bladder CARE™ test for the early detection of bladder cancer. Our validation platform is purpose-built for innovative LDTs, and we look forward to helping bring these breakthrough technologies to patients and providers.”
Dr. Hoa Giang, Co-founder and Chief Data Science Officer of Gene Solutions, added: “Partnering with Pangea gives us a precision validation engine in the U.S. By combining our AI-driven multi-omics innovations with Pangea’s deep scientific expertise and proven track record in CLIA/CAP environments, we’re positioned to deliver affordable, advanced cancer detection and monitoring tools.”
Validation Scope and Assay Prioritization
The collaboration will initially focus on validating two flagship assays from Gene Solutions:
- SPOT-MAS: An AI-powered Multi-Cancer Early Detection (MCED) blood test that integrates ctDNA epigenomics, fragmentomics, and genomics to detect early cancer signals from 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.
Pangea’s comprehensive validation approach spans feasibility, analytical validation, and clinical verification and deployment, ensuring each assay meets the highest standards of analytical performance, clinical utility, and regulatory compliance.
About Pangea Laboratory
Founded in 2014, Pangea Laboratory is a CLIA-certified, CAP-accredited diagnostics company specializing in high complexity testing and validation services for innovative assays, including Next-Generation Sequencing (NGS), and molecular diagnostics. For more information, visit https://pangealab.com.
About Gene Solutions
Gene Solutions is a global biotechnology company headquartered in Singapore with a mission to make advanced genomic solutions accessible and affordable. Leveraging multi-omics, Next-Generation Sequencing (NGS), and AI, the company offers a portfolio including multi-cancer early detection (SPOT-MAS) and comprehensive tumor profiling with ctDNA monitoring (K-TRACK, K-4CARE). Gene Solutions operates CAP-accredited NGS laboratories and has delivered Three million of genetic tests worldwide since 2017. For more information, visit www.genesolutions.com and follow the company on LinkedIn and Facebook.
Important Disclaimer
Some tests may be offered as Laboratory Developed Tests (LDTs) in CLIA-certified, CAP-accredited laboratories; availability and institutional policies vary by state and health system. 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 release includes forward-looking statements subject to risks and uncertainties; neither Pangea Laboratory nor Gene Solutions has any obligation to update these statements. (Regulatory context for LDTs: following the March 31, 2025 federal district court vacatur, FDA issued a final rule implementing the vacatur and reverting to prior regulatory text; CLIA/CAP oversight applies to LDT services.)
Media Contact from Pangea Laboratory:
Sandie O‘Bruba
[email protected]
Media Contact from Gene Solutions:
Rachel Chu
[email protected]
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SOURCE Pangea Laboratory
