NICE Develops a Medtech Innovation Briefing on Caris Molecular Intelligence for Guiding Cancer Treatment

A solid tumour biomarker analysis service intended as a tool to aid decision-making and help identify the best treatment plan

In September 2017, the NICE announced that it has developed a medtech innovation briefing (MIB) on Caris Molecular Intelligence (CMI, Caris Life Sciences) for guiding cancer treatment. CMI is a solid tumour biomarker analysis service intended as a tool to aid decision-making and help identify the best treatment plan for each patient. The technology described is used to help guide future management of locally advanced or metastatic cancer.

CMI uses a number of tumour profiling techniques to analyse protein, RNA and DNA in the tumour:

  • 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 service is updated over time to represent changes in clinical experience and technological feasibility. A full list of the biomarkers analysed by CMI is available on the company’s website.

CMI was marketed as Target Now until 2013.

CMI uses a formalin-fixed paraffin embedded (FFPE) biopsy, ideally taken within 6 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 patient 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.
  • Details of supporting evidence for each therapy and biomarker, grouped by those with potential benefit, lack of benefit or uncertain benefit.
  • A list of any ongoing clinical trials that match the patient's biomarker expression profile (using the company's proprietary Clinical Trials Connector service).
  • 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.

The innovative aspects are that 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 profile is based on the molecular characteristics of the patient's tumour, irrespective of its primary site.

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 and for whom no further guidance on therapy exists.

The main points from the evidence summarised in the briefing are from 5 observational studies in Australia and the US including a total of 1,572 adults in secondary and tertiary care centres. Most evidence shows 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. There is also limited evidence on CMI‑guided treatment for site-specific cancers and metastatic cancer of unknown primary origin, and no evidence on its use in children.

The cost of CMI is 5,800 GBP per test (excluding VAT), which includes the cost of shipping the sample, the full report, and a consultation between the ordering clinician and a member of the company's medical team. The resource impact would be additional costs compared with standard care, including test costs, sample preparation and additional multidisciplinary team meetings. There is no published evidence assessing the cost effectiveness of CMI.

Full briefing you can found here.