Meet Foundation Medicine’s FlexOMx Lab™: A Flexible Research Lab to Support the Development of New Medicines

As part of our mission to transform cancer care, we work closely with biopharmaceutical partners across the discovery and development life cycle -from biomarker translational research through companion diagnostic approval and beyond-to help bring new treatment options to patients.

We understand how arduous the development of new medicines can be. Over the years, we have published more than 1,000 peer-reviewed publications,¹ supported more than 950 clinical trials² and became a global leader in approved companion diagnostic indications, with 50% of all approved companion diagnostic indications for next-generation sequencing testing across the United States and Japan.³

While Foundation Medicine is committed to advancing the cutting-edge research required to bring innovative solutions forward, we also understand that gaps exist between translational research discoveries and future clinical diagnostic solutions. To bridge that gap, we have built a new lab environment: the Foundation Medicine FlexOMx Lab™.

Introducing the Foundation Medicine FlexOMx Lab

To meet the evolving needs of our partners, we have launched our new FlexOMx Lab to provide flexible research use only (RUO) and investigational use only (IUO) offerings to support the research, discovery and development of new medicines by our biopharmaceutical partners.

The Foundation Medicine FlexOMx Lab bridges our expertise in both translational research and regulatory grade clinical trial services by offering a new auditable lab with planned Clinical Laboratory Improvement Amendments (CLIA)-certification and College of American Pathologists (CAP)-accreditation,⁴ giving biopharmaceutical partners the confidence and quality they can trust in the processing of their clinical trial samples while maintaining the flexibility to meet each partner's unique program needs.

Offering a suite of "omics" services, our partners have access to deep research insights, such as:

• Adding gene expression insights from more than 20,000 genes using the same tissue inputs that partners are accustomed to sending us today and our innovative DNA/RNA coextraction method
• Gaining more circulating tumor DNA (ctDNA) insights by enabling lower input processing for plasma samples
• Expanding offerings for hematological malignancies by adding frozen samples to our specimen inputs.

But this is just the start of the FlexOMx Lab.

What is on the horizon for the Foundation Medicine FlexOMx Lab?

To stay abreast of the evolving precision medicine landscape, we will continue to work with our biopharmaceutical and research partners to identify clinically relevant biomarkers in cancer and other disease areas and plan to expand our FlexOMx Lab offerings to provide more flexibility to meet our partners' emerging needs.

With a focus on innovation, we plan to bring new capabilities to the FlexOMx Lab later in 2025 and beyond to support new and existing therapy modalities with assays for:

• Whole exome sequencing (WES) to support novel therapy modalities such as individual neoantigen therapies
• Whole genome sequencing (WGS) to support germline testing and precision medicine applications outside of oncology
• Molecular residual disease (MRD) to support drug development in early-stage cancers and low-shed late-stage cancers

An essential partner in 2025 and beyond

Foundation Medicine has forged the path for high-quality diagnostic testing for 15 years. With the FlexOMx Lab, we're excited to offer our biopharmaceutical and research partners additional value through new, high-quality, flexible services and capabilities that will meet their evolving needs and, ultimately, help more patients benefit from advancements in precision medicine.

© 2025 Foundation Medicine, Inc.

Foundation Medicine and FlexOMx Lab are trademarks of Foundation Medicine, Inc.