Gene Solutions and Pangea Laboratory Establish Strategic Collaboration to Validate Laboratory Developed ctDNA Tests for Precision Screening and Cancer Care in the U.S.
PRNewswire
Irvine (California) [US], January 21: 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."
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 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, NGS, and AI, the company offers a portfolio including multicancer 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 millions 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 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 Gene Solutions nor Pangea Laboratory has any obligation to update these statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. (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.)
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