Caris Life Sciences has secured FDA approval for its MI Cancer Seek assay as a companion diagnostic, capable of guiding treatment decisions across multiple cancer drugs and six different cancer indications. This approval marks a significant step forward in personalized medicine, potentially improving outcomes for patients with various solid tumors.
Broad Applicability Across Cancer Types
The MI Cancer Seek assay is designed to identify patients with solid tumors, including breast cancer, colorectal cancer (CRC), melanoma, non-small cell lung cancer (NSCLC), and endometrial carcinoma, who are most likely to benefit from specific cancer therapies. These therapies include well-known oncology medications such as Merck & Co's Keytruda (pembrolizumab), Eli Lilly's Erbitux (cetuximab), Novartis' Piqray (alpelisib), and Eisai's Lenvima (lenvatinib).
Advanced Sequencing Technology
Caris Life Sciences highlights MI Cancer Seek as the first and only assay to simultaneously utilize whole exome sequencing (WES) and whole transcriptome sequencing (WTS) with FDA-approved companion diagnostic indications for molecular profiling of solid tumors. The FDA has approved its use in both adult and pediatric patients, ranging from one to 22 years old.
The in vitro diagnostic device is designed to detect single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes. It also assesses microsatellite instability (MSI) and tumor mutational burden (TMB) from nucleic acid isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens.
Growing Trend in Companion Diagnostics
The development and utilization of companion diagnostics have been on the rise, particularly in oncology. These diagnostics help screen patients who are likely to respond positively to a specific therapy. The market for oncology tests is projected to grow substantially, from $1.9 billion in 2022 to over $3.1 billion in 2030, according to GlobalData analysis.
Other companies have also been developing companion diagnostics for specific therapies. For example, Labcorp's nAbCyte Anti-AAVRh74var HB-FE assay was cleared as a companion diagnostic for Pfizer’s gene therapy for hemophilia B, Beqvez (fidanacogene elaparvovec-dzkt). Roche also received a CE mark in the European Union for its Ventana HER2 test, a companion diagnostic for Daiichi Sankyo’s and AstraZeneca’s Enhertu (trastuzumab deruxtecan), used to identify patients with low HER2 expression who may benefit from the therapy.
