Caris’s MI Cancer Seek test combines whole exome sequencing (WES) and whole transcriptome sequencing (WTS) for molecular profiling of solid tumours. Image credit: ArtemisDiana / Shutterstock.

The US Food and Drug Administration (FDA) has approved Caris Life Sciences’s MI Cancer Seek as a companion diagnostic to multiple cancer drugs across six cancer indications.

The assay will identify patients with six cancer types, namely solid tumours, breast cancer, colorectal cancer (CRC), melanoma, non-small cell lung cancer (NSCLC) and endometrial carcinoma, who will best benefit from different cancer therapies. The drugs in question include blockbuster oncology medications such as MSD’s (Merck & Co) Keytruda (pembrolizumab), Eli Lilly’s Erbitux (cetuximab), Novartis’s Piqray (alpelisib) and Eisai’s Lenvima (lenvatinib).

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There has been growing interest in developing companion diagnostics in recent years, as it can help screen patients likely to benefit from a particular therapy. One of the areas where companion diagnostics are gaining increased traction is oncology. The market for oncology tests is expected to grow from being worth $1.9bn in 2022 to over $3.1bn in 2030, according to GlobalData analysis.

Caris touted MI Cancer Seek as the “first and only” simultaneous whole exome sequencing (WES) and whole transcriptome sequencing (WTS)-based assay with FDA-approved companion diagnostic indications for molecular profiling of solid tumours. The US regulatory agency approved the use of the MI Cancer Seek test in both adult and paediatric patients aged between one and 22 years.

The in vitro diagnostic device detects single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumour mutational burden (TMB) from the total nucleic acid isolated from formalin-fixed paraffin-embedded (FFPE) tumour tissue specimens.

The use and development of companion diagnostics has increased in recent years. Multiple companies have developed companion diagnostics for high-profile therapies, however, these are usually used for one specific therapy. In April, the FDA cleared Labcorp’s nAbCyte Anti-AAVRh74var HB-FE assay as a companion diagnostic to Pfizer’s FDA-approved haemophilia B gene therapy, Beqvez (fidanacogene elaparvovec-dzkt).

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Roche also received a European Union CE mark for the companion diagnostic for Daiichi Sankyo’s and AstraZeneca’s Enhertu (trastuzumab deruxtecan). The Ventana HER2 test can be used to identify patients with low human epidermal growth factor receptor 2 (HER2) expression, who can best benefit from Enhertu.