Non-small cell lung cancer (NSCLC) is a leading cause of cancer-related mortality, although a rapidly evolving treatment landscape has increased the survival rate in recent years.
New therapies for NSCLC are increasingly biomarker driven, and genetic testing for driver mutations now plays a key role in the diagnostic workflow.
Rapid identification of somatic alterations is critical for selecting and starting the appropriate targeted therapy as quickly as possible, with fast PCR techniques proving invaluable for this in many clinical settings. The need for speed is further underscored by ongoing NHS efforts to meet cancer waiting time targets where reducing time to treatment is a key priority.
Why speed matters in NSCLC
In NSCLC, around half of patients have an identifiable somatic alteration, which could be in several different genes including EGFR, ALK, ROS1, as well as other rarer types. New therapies offer highly targeted treatment options for specific alterations, whereas patients without an identifiable driver are typically treated with conventional chemotherapy, alongside surgery.
Matthew Evison, Professor of Respiratory Medicine and Consultant Chest Physician at Wythenshawe Hospital in Manchester, explained: “To determine the optimal treatment, you need to profile the tumour and understand whether a patient is best treated with chemotherapy, immunotherapy or a targeted therapy. Any delay in the lung cancer pathway can critically affect outcomes; days really do matter.”
The current NHS pathway challenge
In most parts of England, genetic testing is carried out in genomic laboratory hubs (GLH), centralised units responsible for running genomics services in different regions of the country. This means the current pathway for identifying somatic alterations relies on centralised processing which can add time, delaying the start of treatment.
This pathway is prone to delays, as Matthew noted: “A biopsy is taken and examined in the pathology lab to determine if the patient has lung cancer and, if so, whether it’s small cell or non-small cell. Following this, a sample is sent to the GLH for RNA and DNA sequencing – a process that can take about a month to complete – and we cannot progress with optimal therapy for that person until we get those results back.
“Although next generation sequencing (NGS) is the gold standard approach, and national infrastructure has been built around it, data suggests that it cannot deliver results in the time frame required for an efficient cancer pathway.”
Rapid PCR testing in NSCLC using the Idylla™ System
There is a clear need to provide results more quickly in order to speed up the decision-making process, and one way to achieve this is to make use of other diagnostic technologies. The Idylla™ System from Biocartis is a fully automated, real-time PCR based molecular testing system designed to offer results in a minimum amount of time. Idylla™ test cartridges are available for several key driver mutations including EGFR, KRAS and BRAF as well as gene fusions, such as ALK, ROS1 and RET, and splice alterations including MET exon 14 skipping. NGS and other technologies at the regional GLH can follow and be used to provide additional information for a patient’s genetic profile.
Manish Powari, Consultant Cellular Pathologist at the Royal Devon University Hospital, said: “I see several advantages with the Idylla™ System. It’s very easy to use, there’s no need for specialist staff, and it requires minimal hands-on time; you put the sample in, start the device and it gives you a result.
“We predominantly use the device to test one gene at a time, covering the most common clinically relevant mutations. However, the most significant benefit is the improvement in turnaround time, getting results within hours.
“Our oncologists love it as they can get the results and see patients within days of the sample being taken, making first line treatment decisions without delay.”
Accelerating lung cancer treatment pathways
The Idylla™ System is already being used successfully in several NHS trusts across the country. Riyaz Shah, Consultant Medical Oncologist at Maidstone Hospital, finds the Idylla™ System valuable for a wide range of lung cancer patients: “We’ve had our system running for years, even before the GLHs came online, and we often pick up mutations using the system weeks before the genomics results are ready.”
For some patient groups, the quick results provided by the Idylla™ System have the potential to dramatically change treatment pathways.
Riyaz commented: “I think the Idylla™ System really comes into its own when patients present de novo with brain metastases. When this happens, they are often directed to a neurooncology centre for radiotherapy or even neurosurgery. But if they have an actionable somatic alteration – like EGFR or ALK – the drugs we use are so active in the brain that surgery wouldn’t be necessary, I can start targeted therapies immediately.
“The Idylla™ System has been truly transformative in management of these patients as I can get results by the next morning rather than waiting weeks.”
In many situations, the Idylla™ System is located in pathology labs within the hospital, a different location from the surgical suites where biopsies are taken. However, in Manchester, Matthew is working on a project where the system would be integrated into the bronchoscopy suite.
In this model, an additional sample is taken during the procedure and immediately processed in the room, generating results even faster.
Matthew explained: “It’s quite a novel way of doing things – the person taking the biopsy will put the sample in the cartridge and set the Idylla™ System going, which means we get results on the same day. This has already made a massive difference in some cases in terms of the pathway; we’ve sometimes found driver mutations on the day of the procedure.”
Looking ahead
Interest is growing into how rapid PCR testing can be more widely integrated into NHS lung cancer pathways. NGS remains the benchmark for comprehensive profiling, but clinicians are increasingly recognising the value of combining multiple approaches to provide speed alongside depth of information.
This approach has promise in helping the NHS reduce time to treatment for all NSCLC patients, while ensuring no somatic alternations are missed. Ongoing studies aim to generate clinical and economic evidence that will support broader adoption, ensuring that lung cancer patients nationwide can receive the results needed to inform the right treatment at the right time, ultimately improving outcomes in NSCLC.
Pictured: Dr Riyaz Shah and Dr Matthew Evison
