Next Generation Sequencing (NGS), which is becoming more widely known as comprehensive genomic profiling by massively parallel sequencing (CGP), is set to significantly contribute to targeted therapy prescribing and complement other testing methods by 2020. Many genes are analysed simultaneously and it has the potential to detect all mutations in a patient specimen. However, the speed and spread of NGS uptake are not likely to facilitate a revolution in cancer care in this timeframe. There are also other ‘barriers’ acting to slow or prevent the integration of NGS/CGP with diagnostic testing. Here we identify these barriers, but also point out the key drivers that can help break through them on the road to accelerated diffusion of these novel technologies into routine patient management. 1. Barriers to widespread platform and test availability: NGS/CGP diffusion is currently limited to key cancer and reference labs
- Availability is generally restricted to key cancer and reference labs and not a part of community-based cancer care
- Many labs are unable to make the financial commitment in platform acquisition
- Implementing panels using DNA from low quality or quantity of biopsy material is complex – a reflex strategy may be required
- NGS/CGP poses new proficiency testing/external quality assessment (PT/EQA) challenges which are not yet in hand
- Bioinformatic infrastructure requires significant in-house expertise which may need to be developed
2. Barriers to easy access and reimbursement: The cost of NGS/CGP testing and interpretation will remain high relative to other testing methods, until 2020+, so pharma/patient subsidy is required for targeted treatment
- Reimbursement and interpretation concerns for results are not yet clinically actionable for many diseases, the current exception being NSCLC
- Most private payers are restricting access to coverage until better data becomes available
- Medicare only covers NGS/CGP for advanced NSCLC. Coverage for other indications (metastatic melanoma and colorectal cancer) are in draft format
3. Barriers to clear clinical utility and actionable results: Clinical utility for NGS/CGP will be driven by disease-level studies
- Clinical utility is being driven one disease at a time
- NGS/CGP is a complex and labor-intensive methodology, making turnaround time lengthy and often beyond the therapeutic window to make crucial treatment decisions in some disease areas
4. Barriers to new guideline recommendations: NGS/CGP guidelines and recommendations will be key but driven regionally and at a disease level
- Inadequate consensus outside very competitive therapy areas, although NCCN and ESMO guidelines each have wording supporting CGP for advanced NSCLC
- Platform suppliers and the FDA are striving to include NGS/CGP in therapeutic labels
5. Barriers to optimized investment in education, real world studies and awareness to drive demand: Education requires significant financial investment
- There is inadequate investment to address all the barriers and thereby drive accelerated diffusion
- A lack of hands-on real world experience hinders diffusion
Far too many patients are currently missing out on treatment opportunities as diagnostic testing is not generally optimized and is usually under-resourced. NGS/CGP is becoming integral to diagnostic testing and the improvement of patient outcomes. When we focus on the patient, we can see more clearly what action is needed and these endpoints can be seen as ‘drivers,’ breaking through the barriers. Whether in the US and Europe or developing world markets, the diffusion of NGS/CGP for diagnostic testing and improved patient treatment will depend upon smart investment in these key drivers:
- There is a basic need for widespread availability of NGS/CGP testing and platforms in laboratories, not just the big cancer labs, but in regional and community labs, too
- Physicians and patients need easy access and the reassurance of reimbursement
- The wider availability and uptake of NGS/CGP methodology will be driven by clear clinical utility and actionable results
- Therapies and diagnostics are always ahead of guideline recommendations in terms of development but a speedier incorporation of new methodologies into guidelines will inspire confidence among physicians and patients
- Demand will be driven by education, real world studies and awareness, which all require significant and optimized investment
It’s often easier to identify the problem than the solution, but Diaceutics has comprehensive Services in place to help support and guide the commercialization of your diagnostic, whichever platform it requires, all helping to revolutionize patient testing. In our webinar on 29 June 2017, Moving beyond the hype: the reality of NGS in oncology today and in the future, we will explore these and other pertinent topics regarding the potential solutions to these barriers.
