United States: On 9 June 2023, Foundation Medicine, Inc. have announced that they have received approval for FoundationOne®Liquid CDx as a collaborative diagnostic tool for encorafenib (Braftovi) in combination with cetuximab (Erbitux) to detect patients with BRAF V600E mutations in metastatic colorectal cancer (mCRC). The Beacon clinical trial which resulted in amalgam’s approval demonstrated that they could lengthen the life expectancy of patients to roughly 8.4 months, in contrast to the 5.4 months of those who received solely chemotherapy. Colorectal cancer is one of the most common and deadly cancers globally. BRAF V600E mutations are believed to manifest in around 8% of individuals who have metastatic colorectal cancer. FoundationOne Liquid CDx examines over 300 genes related to cancer by using a basic blood sample, in order to offer genomic insights. The test has multiple related diagnostic applications, including non-small cell lung cancer (NSCLC), breast cancer, and colorectal cancer, as well as a general tumor indication that is exclusive to NTRK1/2/3 fusions.

FoundationOne Liquid CDx is intended for prescription use only and is a qualitative in vitro diagnostic test based on next-generation sequencing for patients with solid tumors suffering from advanced cancer. Moreover, FoundationOne®Liquid CDx plays a crucial role in detecting NSCLC patients whose tumors feature EGFR exon 19 deletions or exon 21 L858R substitutions who are eligible for treatment with a range of FDA-approved EGFR tyrosine kinase inhibitors (TKI). When assessing eligibility for treatments that require FoundationOne Liquid CDx as a complementary diagnostic, plasma testing is suitable only in cases where tumor tissue is unavailable.

According to the Chief Medical Officer, Foundation Medicine, “Companion diagnostics are high-quality, well-validated genomic tests that provide critical information to help oncologists make informed treatment decisions for their patients. This new companion diagnostic indication for FoundationOne Liquid CDx provides oncologists with an important, non-invasive genomic testing option for metastatic patients with this difficult to treat condition. For NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21 substitutions, this approval opens new access avenues for targeted treatment options. Following three recent group companion diagnostic approvals for Foundation Medicine’s tissue-based test, FoundationOne®CDx, this first group approval for FoundationOne Liquid CDx builds upon the momentum for more efficient and innovative regulatory approaches to the companion diagnostic approval process. These efforts help to maintain the high-quality standards and rigor of the process, while streamlining the approach to developing TKIs to get these treatments to patients faster.”

According to TechSci Research, Progress in genomic medicine has revolutionized the realm of oncology, allowing for more precise identification, prognosis, and therapeutic interventions. Genomic profiling of tumors enables a thorough analysis of genetic modifications, aiding in the identification of targetable mutations and guiding treatment selection. Approval of FoundationOne Liquid CDx have strengthened the position of Foundation Medicine as a pioneer of molecular profiling for cancer striving to shape the upcoming prospects of clinical care and research. FoundationOne Liquid CDx analyzes 324 genes using freely circulating cell DNA and is authorized by the FDA to identify small variations in 311 genes as a diagnostic companion. The continuous integration of novel gene panels and advancements in testing technologies enhance the efficacy of the test to detect rare genetic alterations and predict response to immunotherapy. Moreover, the approval has further established itself as a significant milestone in delivering broader access to more treatment options.