Celebrating 15 Years of Innovation at Foundation Medicine

In 2010, cancer care was at an inflection point. Targeted therapies were beginning to emerge following the publication of the first detailed analysis of the human genome, and the clinical landscape was on the cusp of change. Foundation Medicine was founded in 2010 with a bold mission to drive a deeper understanding of cancer and harness the full potential of precision medicine.

As we celebrate our 15^th anniversary, I’d like to reflect on what we have achieved in this time through collaboration, scientific innovation and an unwavering commitment to patients.

Forging a path for high-quality genomic testing in advanced cancer

We have known that cancer is a disease of the genome since the beginning of the 20^th century. But it is only in the past two decades that we have had the technology and ability to turn this knowledge into action. By 2010, comprehensive genomic profiling (CGP) gave researchers and scientists the ability to analyze hundreds of genes to detect genomic alterations that were known to drive cancer growth.

Foundation Medicine recognized the vast potential of CGP as a way for physicians to understand the full genomic landscape of a patient’s cancer to help them determine the best possible treatment strategy. Our team of scientists developed one of the first standardized CGP platforms, confirming its accuracy, reliability and clinical relevance through pioneering clinical studies and rigorous assay validation in real-world clinical settings. Through partnerships and collaborations with stakeholders from across the cancer landscape, we have led the transformation of cancer care for 15 years.

FoundationOne®CDx paved the way for patient access to high-quality, accessible genomic testing in 2017 as the first next-generation sequencing-based companion diagnostic to undergo parallel review by the U.S. Food & Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS). Securing FDA approval and a simultaneous preliminary national coverage determination (NCD) was the first step toward expanding access to precision medicines and harnessing their potential for cancer patients.

In 2020, we built on this legacy with the FDA approval of FoundationOne®Liquid CDx, our comprehensive pan-tumor liquid biopsy test. Today, we are the only company to offer both FDA-approved tissue and blood-based companion diagnostic testing,¹ and we are the global leader in companion diagnostic approvals with more approved companion diagnostic indications for next-generation sequencing in the US and Japan than any other company.²

Our work has helped fundamentally shift the paradigm for cancer care toward precision medicine, setting a standard that continues to influence our approach to cancer worldwide. 

A foundation of scientific innovation

Foundation Medicine is, at its core, a genomics company committed to transforming the way we treat cancer. Our high-quality tests not only play a critical role in optimizing outcomes for today’s patients but also enable us to continue to accelerate progress for the cancer patients of tomorrow. We learn more about cancer with every test we deliver, and the knowledge we have gained from 15 years of diagnostic testing has unlocked new insights into tumor biology and forged new directions in treatment. 

For example, we were pioneers in developing tumor mutational burden (TMB),³ a new biomarker that is now used in routine clinical practice to inform immunotherapy treatment decision-making. We also demonstrated the clinical relevance of MET exon 14 skipping mutations,⁴ rare mutations that drive non-small cell lung cancer proliferation, and supported the development of a new precision treatment for patients with these mutations.⁵

Our scientists have contributed to more than 1,000 peer-reviewed publications,⁶ and we’ve collaborated with providers, research institutions, scientists and biopharmaceutical partners from across the cancer landscape to support over 950 clinical trials.⁷ By working with our biopharmaceutical partners, we have helped bring over 35 medicines to more patients through our FDA-approved companion diagnostic indications,⁸ helping to ensure that emerging treatments reach the right patients faster and improving the options available for those facing some of the most challenging cancers.

Looking ahead

Foundation Medicine has continued to evolve with the changing cancer landscape to ensure we are well-positioned to deliver the best innovation and services to healthcare providers, researchers, biopharmaceutical partners and patients. I want to thank every person who has been a part of Foundation Medicine’s journey so far, along with the many stakeholders and partners we have collaborated with to make a difference in the lives of so many patients and their families. 

However, our work is far from done. 2025 is both an anniversary and an important milestone for the future of Foundation Medicine. 

This year, we will continue to expand our portfolio of high-quality tests to incorporate new options for germline testing and treatment response monitoring and offer new innovative and flexible capabilities for our biopharmaceutical partners in our new FlexOMx Lab™. As we look to the future, we will continue to invest in accelerating momentum in areas such as molecular residual disease (MRD) and the development of companion diagnostic platforms for our hematological and RNA products.

Through continued investment, expansion of our world-leading team and innovative collaborations with existing and new partners, we will continue to adapt to the changing demands of the cancer landscape and deliver new hope and transformative solutions for more patients living with cancer.