Pangea Laboratory and Gene Solutions Unite for Cancer Diagnostic Breakthroughs in the U.S.

Strategic Collaboration to Advance Cancer Diagnostics

Pangea Laboratory, a leader in innovative cancer diagnostics, has recently partnered with Gene Solutions, a prominent global biotechnology firm, to enhance cancer detection and monitoring in the United States. This collaboration aims to validate AI-driven liquid biopsy assays, potentially transforming the approach to cancer diagnostics.

As a CLIA-certified and CAP-accredited entity, Pangea Laboratory is set to lead the validation of Gene Solutions' pioneering multi-omics technologies. The agreement outlines a comprehensive validation process, ensuring that the developed assays meet stringent regulatory and clinical standards. Gene Solutions will contribute by providing operational procedures, funding, and expertly trained personnel from its highly regarded facilities in Singapore and Vietnam.

According to John Moore, CEO of Pangea Laboratory, this partnership is crucial as it aligns with their mission to offer advanced diagnostic solutions that can deliver timely results. He stated, "These assays not only enhance our existing portfolio, specifically complementing our Bladder CARE™ test for bladder cancer detection but also leverage our robust validation platform designed for innovative Laboratory Developed Tests (LDTs)."

Innovative Assays Designed for Detection

The initial focus of this partnership will target the validation of two flagship assays from Gene Solutions:

1. SPOT-MAS™: This innovative multi-cancer early detection (MCED) blood test integrates cutting-edge technologies such as ctDNA epigenomics, fragmentomics, and genomics. It allows the detection of early cancer signals from just a single 10 mL blood draw, a significant advancement given that it assesses across ten major cancer types and 75 subtypes.

2. K-4CARE™: This precision oncology assay employs comprehensive genomic and transcriptomic profiling alongside molecular residual disease (MRD) detection. Its dual-functionality assists in guiding targeted therapy selection while offering valuable insights into ctDNA-MRD monitoring over time.

Pangea's thorough validation process encompasses feasibility studies, analytical validation, and clinical verification, ensuring that both assays conform to the highest standards concerning analytical performance and regulatory compliance.

A Future of Enhanced Diagnostics

Dr. Hoa Giang, Co-founder and Chief Data Science Officer of Gene Solutions, highlighted the importance of this partnership, remarking, "Working with Pangea presents an opportunity to utilize an exceptional validation environment in the U.S. By synergizing our AI-driven innovations with Pangea's scientific expertise, we aim to deliver affordable and sophisticated tools for cancer detection and management."

As soon as the assays are validated, they will be developed as laboratory-developed tests (LDTs) and offered within Pangea's cutting-edge facility in Irvine, California. This strategic effort brings advanced cancer monitoring and detection capabilities closer to patients, significantly impacting patient care outcomes.

Both companies emphasize the need for responsible and regulated diagnostic practices, with tests made available in accordance with CLIA/CAP guidelines to ensure patient safety and reliability of results.

About Pangea Laboratory

Founded in 2014, Pangea Laboratory focuses on high-complexity testing and validation services for innovative assays, including next-generation sequencing. Their commitment to enhancing diagnostic capabilities illustrates their mission to deliver efficient, timely medical solutions.

About Gene Solutions

Gene Solutions, headquartered in Singapore, aims to democratize access to advanced genomic solutions via multi-omics technologies. With a track record of over three million genetic tests delivered since 2017, they are dedicated to making cancer detection more effective and widespread.

This collaboration marks a significant stride towards revolutionizing cancer diagnostics and patient care, setting the stage for groundbreaking methodologies in the fight against cancer.