Foundation Medicine Inc. has carved out a big role in healthcare, changing the way doctors diagnose and treat cancer and other tough diseases. Precision medicine—using the unique details of each patient’s genetics instead of the old one-size-fits-all approach. Since day one, they have become a go-to partner for patients, doctors, researchers, and BioPharma companies all trying to figure out the best ways to tackle modern cancer care. With their genomic knowledge, Foundation Medicine gives doctors better tools to choose the right treatment based on what is really happening inside a patient’s cells.

Foundation Medicine works closely with researchers, Pharma companies, advocacy groups, government agencies, insurance plans—involved in cancer care. Their goal is to prove that biomarker testing really matters and to help more people, including doctors and patients, understand why it is important. The company keeps pushing into new territory; using everything they have learned about precision medicine to design smarter diagnostic and treatment strategies. Moreover, while cancer is their focus, they are already looking at how these approaches can help with other diseases too.

At the heart of it all, Foundation Medicine still runs on the bold ideas that came out of the Human Genome Project and the Cancer Genome Atlas. The founders pictured a future where every cancer patient could get targeted treatment, shaped by genetic insights right at the doctor’s office. That vision has not faded. It keeps driving Foundation Medicine as they work to change lives and move precision medicine forward.

Products by Foundation Medicine, Inc.

FoundationOne®CDx

FoundationOne®CDx represents advancement in precision cancer medicine as the first FDA approved tissue based broad companion diagnostic validated for all solid tumors. This complete genomic profiling test analyzes guideline recommended genes from formalin fixed, paraffin embedded tissue samples providing physicians with clinically actionable information to guide treatment decisions. The test delivers results within a median turnaround time of 8.8 days enabling rapid clinical decision making at the point of care.

The test's capabilities extend across multiple therapeutic domains. FoundationOne®CDx identifies mutations associated with over 20 FDA approved targeted therapies including EGFR tyrosine kinase inhibitors for non small cell lung cancer and BRAF inhibitors for melanoma and various other targeted agents across solid tumor types. Beyond targeted therapy identification, the test reports microsatellite instability and tumor mutational burden to inform immunotherapy decisions along with homologous recombination deficiency signatures. Physicians can also order PD-L1 immunohistochemistry testing as an optional add on to further personalize treatment strategies.

FoundationOne®CDx demonstrates exceptional patient accessibility through broad insurance coverage. The test maintains national coverage for qualifying Medicare and Medicare Advantage patients across all solid tumors with an additional 80 commercial health plans providing coverage. This coverage translates to patient benefits with approximately 87 percent nearly 9 out of 10 patients paying close to nothing for testing. The test's flexibility allows seamless reflexing to FoundationOne®Liquid CDx, the company's blood based companion enabling providers to transition between tissue and liquid biopsy formats as clinical circumstances warrant. By democratizing access to molecular level cancer insights, FoundationOne®CDx empowers physicians to make informed treatment decisions grounded in each patient's unique genomic profile fundamentally transforming the standard of care for solid tumor patients.

FoundationOne®Liquid CDx

FoundationOne®Liquid CDx establishes a new standard for noninvasive cancer genomic profiling through a simple blood draw requiring only two 8.5 milliliter tubes of peripheral whole blood. As an FDA-approved blood based companion diagnostic it represents the most comprehensive liquid biopsy available analyzing over 300 genes significantly more than competing liquid biopsy platforms. This expansive gene panel enables detection of alterations across multiple cancer indications while identifying clinical trial opportunities for patients with solid tumors.

Beyond gene sequencing, FoundationOne®Liquid CDx reports blood tumor mutational burden, microsatellite instability high status and tumor fraction values as professional laboratory services. These biomarkers provide additional insights for immunotherapy selection and patient stratification. The test's companion diagnostic indications span multiple solid tumor types with particular utility in non small cell lung cancer where it identifies ALK rearrangements, BRAF mutations, EGFR alterations, MET exon 14 skipping events and ROS1 fusions each linked to specific FDA approved targeted therapies.

FoundationOne®Liquid CDx delivers exceptional accessibility for both patients and providers. National Medicare and Medicare Advantage coverage applies across all solid tumors, complemented by coverage from 80 commercial health plans. Like its tissue based counterpart the test achieves remarkable patient affordability, with 87 percent of patients experiencing zero high costs. The test's noninvasive nature eliminates the need for tissue biopsy reducing patient burden while enabling serial monitoring throughout treatment. The test portfolio's flexibility permits easy reflexing between FoundationOne®Liquid CDx and FoundationOne®CDx, allowing clinicians to seamlessly integrate tissue and liquid biopsy approaches. This comprehensive, accessible and patient-friendly approach to genomic profiling positions FoundationOne®Liquid CDx as a transformative tool for precision cancer medicine.

FoundationOne®Heme

FoundationOne®Heme addresses a critical clinical need by providing genomic profiling specifically designed for hematologic malignancies and select solid tumors. This laboratory developed test combines DNA and RNA sequencing to detect all four main classes of genomic alterations including substitutions, indels, copy number variations and complex fusion events. With over 400 DNA sequenced genes and more than 250 RNA sequenced genes, FoundationOne®Heme delivers expansive coverage across guideline recommended genes in leukemias, myelodysplastic syndromes and other blood cancers. Results are delivered within two weeks of specimen receipt enabling timely clinical decision making. A significant recent enhancement includes the reporting of Variant Allele Frequency percentages on all clinical reports supporting more nuanced clinical interpretation, diagnosis confirmation, prognosis assessment and patient monitoring throughout treatment.

FoundationOne®Heme empowers physicians to identify potential targeted therapy options while simultaneously detecting alterations in prognostic genes and facilitating disease sub classification. This dual capability enhances both therapeutic planning and prognostic understanding particularly valuable in complex hematologic malignancies where accurate classification directly influences treatment selection and patient outcomes. The test's comprehensive approach to genomic analysis detecting both common and novel alterations through integrated DNA and RNA sequencing positions FoundationOne®Heme as an essential tool for precision medicine in hematologic oncology.

Dan Malarek | CEO

Dan Malarek is Chief Executive Officer at Foundation Medicine. Prior to joining Foundation Medicine in 2023, he held several key positions within Roche Diagnostics. Most recently, Malarek worked as the Global Head of Marketing & Customer Insights, based in Rotkreuz, Switzerland, moving to that role after serving as the General Manager for Roche Diagnostics Norway for four years.

“Foundation Medicine brings together a wealth of expertise and experience across healthcare delivery, biomedical research, and the clinical diagnostics and laboratory industries.”