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Evolution of Companion Diagnostics in Cancer Treatment

NextEdge Admin

06 May 2024

3 min 0 sec

Trastuzumab (Herceptin) marked a pivotal moment in drug development by pioneering the drug-diagnostic codevelopment model. Its approval by the FDA in 1998, alongside the HER2 assay, HercepTest, set the stage for this paradigm shift. The importance of accurate companion diagnostics became evident, as targeted cancer drugs like trastuzumab relied on them for optimal efficacy. Over time, the FDA’s list of approved companion diagnostic (CDx) assays has expanded, reflecting the evolution of this trend.

Initially, immunohistochemistry (IHC) and in situ hybridization (ISH) dominated the CDx landscape. However, the introduction of the cobas 4800 BRAF V600 Mutation Test in 2011 marked a significant milestone with the advent of PCR-based CDx assays. PCR has since become the largest CDx group. More recently, next-generation sequencing (NGS) has emerged as another prominent CDx platform. For example, the FoundationFocus CDxBRCA Assay, the first FDA-approved NGS-based CDx, detects BRCA1/2 alterations in ovarian cancer patients for potential rucaparib treatment. This chronological progression underscores the expanding role of diverse technologies in companion diagnostics.

In recent years, FDA-approved tumor-agnostic drugs like larotrectinib (Vitrakvi) have further emphasized the importance of companion diagnostics. For instance, the approval of the FoundationOne CDx assay for NTRK fusion testing demonstrates its crucial role in identifying patients who may benefit from such targeted therapies. Similarly, pembrolizumab (Keytruda) targets high tumor mutational burden, with FDA approval for FoundationOne CDx assay testing in solid tumors, underscoring the significance of companion diagnostics in personalized medicine.

Several companies offer CDx assays utilizing different technologies. Myriad Genetic Labs provides BRACAnalysis CDx and Myriad myChoice CDx, employing PCR and NGS, respectively. Foundation Medicine offers FoundationOne CDx and FoundationOne Liquid CDx, both utilizing NGS technology. Guardant360 CDx utilizes NGS. These examples illustrate the diverse array of technologies employed in companion diagnostics, reflecting the complexity and precision demanded by modern cancer treatment approaches.