- Caris Molecular Intelligence (CMI) is used to help guide future management of locally-advanced or metastatic cancer
- It uses multi-platform molecular profiling to provide a report describing which cancer treatments may have clinical benefit and any relevant, open clinical trials
- The intended place in therapy would be as a tool to help guide treatment decisions for locally-advanced or metastatic cancer in people who are fit for further treatment but have exhausted standard evidence-based treatment options
- The briefing provides feedback from five observational studies showing that CMI guided treatment is associated with better progression-free survival than clinician decisions alone. There is also some evidence that CMI may lead to improved overall survival
- Key uncertainties around the evidence are that there are currently no randomised controlled studies comparing CMI guided treatment with non-CMI guided treatment
- The cost of CMI is £5,800 per test, which is a higher cost when compared with standard care
A tumour analysis system that could help with decision-making and support the identification of the best treatment options for people with cancer is the subject of the latest Medtech Innovation Briefing from the National Institute for Health and Care Excellence (NICE).
The briefings aim to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies.
The information provided includes a description of the technology, how it’s used, and its potential role in the treatment pathway.
They also include a review of relevant published evidence and the likely costs of using the technology, but they are not NICE guidance and do not make any recommendations on the value of using the technologies. Whether or not to use the products described is entirely the choice of local staff.
However, they will help to avoid the need for organisations to produce similar information, so saving staff time, effort and resources.
The latest briefing explores the potential impact of using the Caris Molecular Intelligence (CMI) system, manufactured by Caris Life Sciences, for solid tumour biomarker analysis.
The system uses a number of tumour profiling techniques to analyse protein, RNA and DNA in a tumour, including:
- Immunohistochemistry to determine level of protein expression
- In-situ hybridisation to detect deletions and amplifications in a specific set of genes
- RNA sequencing to identify fusions and rearrangements of 53 genes
- Next-generation sequencing to detect DNA mutations in 592 genes, amplifications in 442 genes, total mutational load and microsatellite instability
The system uses a formalin-fixed paraffin embedded (FFPE) biopsy, ideally taken within six months of profiling, which is sent, using a Caris specimen shipper kit, to the Caris laboratory in the US for analysis. CMI uses a proprietary algorithm to generate a patient report, which is sent electronically to the clinician within 14 days of receiving the sample and all relevant documents. The report comprises a summary of important findings, including lineage-relevant biomarkers and which chemotherapies, immunotherapies, hormone therapies or targeted therapeutics may be effective against the tumour. It also details supporting evidence for each therapy and biomarker, a list of any ongoing clinical trials that match the patient's biomarker expression profile, and appendices with full assay results, value information and technical details for each biomarker and technology.
The report is sent to the clinician with a written consultation from a member of the Caris medical team. Caris also offers a telephone call to the clinician to discuss the individual case in the context of treatment history and available treatment options.
There is no current guidance or standard NHS pathway for locally-advanced or metastatic cancer in people who have exhausted all standard lines of therapy, but who remain fit enough for further treatments. Some molecular profiling tests are currently used currently for certain cancer types to test whether it is likely that the patient's cancer will respond to a particular chemotherapy drug. In addition, the 100,000 Genomes project (Genomics England) can provide similar sequence data on the tumour and clarify whether certain pathogenic mutations are germline or somatic. However, this information does not include the association between a detected abnormality in the molecular profile and a treatment recommendation.
The briefing summarises five studies including a total of 1,572 patients. Three are published prospective studies, one is a retrospective study from a registry-based cohort, and one is a conference abstract reporting a large prospective study. None were carried out in the UK.
The studies suggested that the system is associated with better progression-free survival than clinician decisions alone. There is also some evidence that CMI may lead to improved overall survival
However, key uncertainties around the evidence are that there are currently no randomised controlled studies comparing CMI guided treatment with non-CMI guided treatment
To read the briefing in full, click here.