Foundation Medicine and Natera this week announced the launch of an early access program for the investigational and clinical use of FoundationOne Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay.
Foundation Medicine specializes in molecular profiling for cancer, while Natera specializes in cell-free DNA testing.
The current imaging-based care standard for cancer monitoring can be imprecise or inapplicable to all cancer types, negatively impacting patient outcomes. Although immunotherapy is broadly used, assessing therapy response and disease progression remains challenging.
FoundationOne Tracker may complement imaging to better assess treatment response and inform next steps, particularly when imaging is ambiguous. It combines genomic information derived from FoundationOne CDx -- Foundation Medicine's tissue-based comprehensive genomic profiling test -- with Natera's personalized assay design and ctDNA analysis.
The researchers' goal is to allow physicians to serially monitor cancer patients' response to treatments, such as immunotherapy, using a simple blood draw, then use those insights to optimize future treatment decisions.
In February 2022, FoundationOne Tracker was granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for use in molecular residual disease detection in early-stage cancer after curative therapy. Although now available through the early access program to a limited number of clinical customers, the companies plan to enable broader U.S. availability later in 2023.
"We developed FoundationOne Tracker to help physicians identify patients who are resistant to their current treatment and may need additional therapy, or those who are responding well to therapy and may benefit from skipping unnecessary doses," said Foundation Medicine CEO Dr. Brian Alexander in a statement. "With this new tool that leverages the molecular fingerprint of the cancer, we hope to maximize the impact of genomic profiling to support a higher degree of personalized cancer care for patients."