Comprehensive Approach to Companion Diagnostics

Genomic biomarkers have redefined how we treat cancer. By revealing the unique features of each person’s tumor, biomarkers often allow physicians to select highly specific therapies that are most likely to benefit their patients. As such, companion diagnostics that measure these biomarkers have become essential predictive assays for simplifying decision-making, reducing uncertainty and improving outcomes. In short, they help place the “person” in personalized healthcare by matching patient to therapy in a highly effective and reliable way.

Companion diagnostics have also played an important role in drug development by improving the likelihood that a medicine succeeds in clinical trials. For example, one study showed that biomarker-based targeted therapies had a 62% success rate compared to the 11% observed in drugs without a biomarker-targeted indication.1

Still, there are inefficiencies in how we use these tests. Currently, most companion diagnostics test for one biomarker at a time, which can lead to treatment delays or miss valuable information. With the continued development of new targeted therapies, there is a growing need for a ubiquitous, clinically-validated approach that tests for multiple biomarkers simultaneously.

FoundationOne CDx: One test that incorporates multiple companion diagnostics to inform treatment decisions specific to each patient’s cancer

At this year’s World Conference on Lung Cancer, we’re excited to present validation data for FoundationOne CDx, a comprehensive genomic profiling assay that incorporates multiple FDA-approved companion diagnostics in a single platform to guide personalized treatment decisions across a diverse range of solid tumors. This assay also simultaneously provides potentially actionable information through next-generation sequencing of 324 genes known to drive cancer growth and predictive genomic biomarkers for immunotherapy such as microsatellite instability (MSI) and tumor mutational burden (TMB).

This approach could provide oncologists with a single assay to help identify patients likely to respond to various FDA-approved targeted therapies across multiple types of cancer. Use of a single test also conserves tissue by avoiding sequential testing of the same tissue sample and reducing the need for another tissue biopsy to complete diagnostic testing. Together, this single platform has the potential to guide targeted therapy and immunotherapy treatment decisions as well as determine eligibility for many biomarker-driven clinical trials evaluating targeted therapies and immunotherapies.

Study results showed that FoundationOne CDx reliably detected alterations in EGFR, ALK, BRAF, ERBB2, KRAS and BRCA1/2 genes and demonstrated robust concordance with FDA-approved companion diagnostics currently used to match targeted therapies to patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer.

Foundation Medicine World Conference on Lung Cancer WCLC Multiple CDx with a Single Test Image

Specifically, concordance was shown by comparing FoundationOne CDx with other FDA-approved companion diagnostic tests. In each of the separate studies, concordance was measured as positive percent agreement (PPA) with these other tests and ranged from 89.4% to 100%.

FoundationOne CDx is currently under review by the U.S. Food and Drug Administration (FDA) and by the Centers for Medicare & Medicaid Services (CMS) as part of their Parallel Review program for breakthrough devices.

A comprehensive approach to the future of precision medicine

A comprehensive, profiling assay concordant with multiple companion diagnostics would represent a major advance in applying precision medicine to improve patient care. With more than 50% of pipeline therapies projected to ultimately have a biomarker2, there is an unmet need for solutions that help simplify this incredibly complex environment for the entire cancer care ecosystem.

For physicians and patients, this test could save time and conserve precious tissue, as well as reduce the guesswork that is often associated with testing for biomarkers one at a time.

In addition, new genomic markers can be added onto FoundationOne CDx’s versatile platform rather than developing new tests for each one, helping to streamline and accelerate drug development for the biopharma community and potentially bring new personalized medicines to patients faster.

We are acquiring new knowledge about the molecular drivers of cancer at an unprecedented pace. To keep up, we need to develop approaches that optimize the treatment decision process.

We believe offering treating physicians a single, clinically-validated and FDA-approved assay that provides multiple companion diagnostics across several types of cancer and helps guide use of targeted therapy, immunotherapy or clinical trials could provide significant clinical value across the global oncology community.

Learn more about these data at the following presentations:

P2.02-052 -- A clinically-validated universal companion diagnostic platform for cancer patient care; Oct 17, 9:30am – 4:00pm JST, Exhibit Hall

P3.02-061 – An ALK follow-on companion diagnostic using CGP for clinical care of patients with NSCLC; Oct 18, 9:30am – 4:00pm JST, Exhibit Hall

P3.02-062 – An EGFR follow-on companion diagnostic for clinical care of patients with NSCLC; Oct 18, 9:30am – 4:00pm JST, Exhibit Hall


1 Falconi A, et al. Biomarkers and receptor targeted therapies reduce clinical trial risk in non-small-cell lung cancer. J Thorac Oncol. 2014 Feb;9(2):163-9.

2 Developments in Cancer Treatments, Market Dynamics, Patient Access and Value - Global Oncology Trend Report 2015. IMS Institute for Healthcare Informatics. Available at: