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Janssens J, Gallagher WM, Dean A, Ussia G, Stamp G. Tumor profiling-directed precision cancer therapy – comparison of commercial and academic clinical utility. Int J Surg Surgical Proced. 2017; 2: 123.

Comparison of four commercially available tumour profiling services highlights superiority of Caris Molecular Intelligence

A new publication,1 published in October 2017, has compared the clinical utility of four commercially available tumour profiling services: Caris Molecular Intelligence (CMI), FoundationOne (Foundation), OncoDEEP, and Paradigmdx (PCDx). The researchers also compared the clinical utility of the commercially available tumour profiling services with purely academic approaches to tumour profiling.

In precision medicine in cancer, clinical utility is defined as the generation of clinically useful and relevant information that can change the course of the disease for a patient, resulting in improved outcomes. In this paper, the researchers looked specifically at the clinical utility and clinical benefit of the tumour profiling services, the impact of the tumour profiling services on treatment choice, and the technical details and quality of each of the services. To do so, they analysed published clinical data widely available in the literature.

The researchers found that CMI had the most impact on treatment choice at 77%. This meant that in 77% of cases the physician’s planned treatment was changed after profiling with CMI. By contrast, PCDx changed treatment decisions in 26% of cases and FoundationOne changed treatment decisions in only 19% of cases. The researchers were unable to find published data that demonstrated the impact on treatment decisions using OncoDEEP. Tumour profiling from leading academic institutions changed treatment decisions in 20% of cases.1

The services were compared for clinical benefit, which is the positive effect on patient health. It can be measured in a number of ways including PFS ratio ≥ 1.3 and response evaluation criteria in solid tumors (RECIST) response. The researchers found that the clinical benefit in patients whose treatment was chosen in line with the results of molecular profiling was 50% for CMI, 43% for PCDx, 34% for Foundation, and 33% for academic approaches.1

CMI came out on top with regard to clinical utility as well. Clinical utility refers to the percentage of patients who have clinical benefit compared to the total number of patients that undergo profiling.2 CMI had the highest clinical utility at 34%, compared with PCDx (11%), Foundation (6%), and academic approaches (5%). The clinical utility for OncoDEEP could not be calculated as the researchers could not find any published literature demonstrating clinical benefit or impact on treatment choice for the service.1

The researchers reasoned that the much higher clinical utility of CMI is due to the fact that the majority of patients treated in line with the results of CMI profiling are treated with conventional cytotoxic chemotherapies. This, they said, was a result of the inclusion of immunohistochemistry (IHC) and in situ hybridisation (ISH) testing in CMI, whereas services which rely on NGS-only testing (such as Foundation) were more likely to recommend targeted therapies.

The researchers also noted the many and vast differences in quality and technical details between the different profiling services. Only CMI and Foundation use Illumina technology for NGS, whereas PCDx and OncoDEEP use Ion Torrent.  Illumina is the industry standard and has received FDA approval for medical uses, whereas Ion Torrent has not been approved for medical diagnostics and is therefore recommended for research purposes.1 Ion Torrent uses hotspot sequencing which means that it has a much higher error rate than Illumina sequencing which utilises full exon sequencing. In particular, when sequencing insertions and deletions the error rate of Ion Torrent sequencing is twice that of Illumina sequencing.3

The researchers noted the quality certifications achieved by the four services. CMI is the only service with CLIA, CAP, NYSDOH and ISO15189:2012 accreditations (view all CMI certification). In addition, the researchers highlighted the extra quality measure of laboratory-developed tests that CMI does for IHC testing.1

 

Summary

  • A new publication has compared clinical benefit and utility, impact on treatment choice and technical quality of four commercially available tumour profiling services and profiling provided at leading academic institutions.
  • Caris Molecular Intelligence had the highest clinical benefit (50%) and clinical utility (34%) of all of the tumour profiling services evaluated, both commercial and provided by leading academic institutions.
  • Caris Molecular Intelligence had the highest impact on treatment choices at 77% which was much higher than Paradigmdx (26%) and FoundationOne (19%).
  • Caris Molecular Intelligence is the only service with CLIA, CAP, NYSDOH and ISO15189:2012 accreditations.

 

References

  1. Janssens J, Gallagher WM, Dean A, Ussia G, Stamp G. Tumor profiling-directed precision cancer therapy – comparison of commercial and academic clinical utility. Int J Surg Surgical Proced. 2017; 2: 123. [PDF]
  2. Russell KJ, Janssens J, Dean A, Hernandez A, Voss A. Comparison of Utility Cost in three commercially available precision medicine approaches in oncology. Value in Health, Vol. 20, Issue 9, A590. [PDF]
  3. Salipante SJ, Kawashima T, Rosenthal C, Hoogestraat DR, Cummings LA, et al. Performance comparison of Illumina and Ion Torrent Next-Generation Sequencing platforms for 16S rRNA-based bacterial community profiling. Appl Environ Microbiol. 2014; 80: 7583-7591. [Full text]
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