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Targeted therapies bring hope to oncology patients
As the development of targeted therapies has accelerated over the past 20 years, testing for relevant, actionable genetic alterations (biomarkers) has become a necessary and routine component of oncology patient management. Studies demonstrate that availability of a molecular or genomic profile is associated with improved patient outcomes.
Multiple studies demonstrate that access to genomic profiling information before first-line therapy decisions may improve patient outcomes. In a study of 326 NSCLC (non small cell lung carcinoma):
- 24.6 months was a median overall survival of patients with a genomic profile available before the therapy decision
- 6.2 months was a median overall survival of patients without a genomic profile available before the therapy decision
This represents 4x improvement in the outcome when decisions are informed by genomic testing (Figure 1).1
Figure 1. Odds of patient survival (OS) with and without a genomic profile available for a treatment decision.
Gaps in clinical practice of genomic profiling
Ongoing limitations in genomic profiling workflows create barriers to efficient and informed treatment decision-making.2
Limited access to appropriate testing
Not all institutions have in-house genomic testing capabilities, leading to reliance on send-out labs and extended turnaround times.
Sample adequacy and technical constraints
Small biopsies and limited tissue samples often require sequential testing, increasing the risk of tissue exhaustion.
Long turnaround times
Traditional workflows delay treatment initiation or result in therapy decisions made before biomarker results are available.
Rapid NGS offers a solution
Based on the published data and experience of many leading cancer centers, there is an emerging solution for lung and other cancers: rapid next-generation sequencing (NGS).
Benefits of Rapid NGS
- In-house, close to the patients, and fast, so you get the complete potentially actionable biomarker results to guide the first line therapy
- Tissue saving, so even small biopsies or cytological specimens can be analysed, and number of potential re-biopsies is kept to minimum
"By selecting the appropriate methods, optimising sample handling, ensuring rapid and reliable results, and collaborating effectively with clinical teams, pathologists can significantly contribute to the success of personalised cancer treatment. Using rapid NGS, we analyse both tissue and liquid biopsy samples, achieving a TAT of up to 3 days in 82% of cases and a failure rate of <1%."3
Rapid lung NGS is designed to work alongside histopathology and immunohistochemistry (IHC), not in isolation (Figure 2).
Integrated rapid NGS workflow benefits include:
- Parallel processing of histopahology, IHC, and genomic profiling
- Faster delivery of a complete biomarker profile
- Clear, actionable insights for oncologists at the point of care
This approach may minimize delays caused by sequential testing and help support multidisciplinary collaboration.
Figure 2. Rapid next-generation sequencing workflow.4
Rapid NGS workflows are highly automated, and experience from regional and community hospitals shows they can be successfully implemented even in labs with limited prior experience.
Next-day results: A laboratory implemented a rapid NGS workflow that enables results to be entered into the medical record by the next day. Due to its high level of automation, this test is one of the easiest to train new technologists on among the 50 assays performed in the lab.5
2-day workflow: A laboratory with no prior NGS experience successfully accredited a rapid NGS workflow for both FFPE tissue and liquid biopsy, enabling them to deliver high-quality service to oncologists and patients.6
3-day turnaround time (TAT): In a real-world community hospital setting, rapid amplicon-based NGS delivered genomic profiling results with a median turnaround time of three days—compared to more than two months previously required to obtain biomarker results.4
Addressing tissue sample input challenges
Some tumor samples, such as fine needle aspirates or other cytology samples, are very small. Therefore, it is crucial that NGS technology requires as small a sample input as possible.
- Some NGS methods, such as those based on hybrid capture technology, require a high sample input
- Amplicon-based rapid NGS can deliver results from much smaller amounts of material (Figure 3); this may be associated with a direct impact on patient outcomes
Figure 3. Comparison of sample input required for various NGS methods.
Rapid NGS is enabling clinicians and reducing biomarker testing costs
In this recorded webinar, learn how the Massachusetts General Hospital (MGH) Center for Integrated Diagnostics (CID) has consolidated a legacy single-gene testing system into one workflow based on fast and automated NGS to produce a rapid lung molecular testing program.
View this webinar to:
- Learn from the experiences of a leading cancer center in consolidation of NSCLC biomarker testing into a Rapid Lung NGS program
- Understand the positive implications for oncologists and patients with cancer from the oncologist point of view
- Understand how the new consolidated workflow saves time and resources
Community-based Rapid NGS offers considerable advantages in clinical cancer care
In this free on‑demand webinar, Dr. Brandon Sheffield of Canada‑based William Osler Health System shares the organization's experience with implementing NGS in routine oncology biomarker testing.
In their pilot study, 578 solid tumor samples underwent genomic profiling. All testing was performed by one group of technologists within the same division of the laboratory, achieving a median turn‑around time (TAT) of three business days.4
The benefits of keeping molecular testing in-house as viewed by experts from around the globe
Democratization of NGS is the key to accelerating cancer care.
"Significantly shorter time to results enables faster and optimal treatment decisions."
"Small sample requirement provides biopsy stewardship, tissue saving."
"It improves care coordination between multidisciplinary teams, leading to true personalized medicine."
"Allows for the development of local expertise in biomarker testing to support the future of precision medicine."
Rapid NGS frequently asked questions
Rapid next-generation sequencing (rapid NGS) refers to an NGS workflow that generates results in 1 to 2 days, depending on the number of samples being analyzed. In some cases, the full workflow can be completed in as little as next day. Ideally, rapid NGS means the full end-to-end process from a biological sample, such as tissue or blood, through nucleic acid extraction, quantification, library preparation, sequencing, and data analysis. Because the term is often used loosely, it is important to check which part of the workflow is actually included. Some may describe only one step, such as sequencing, as “rapid NGS,” rather than the full sample-to-result workflow.
Rapid NGS is important for cancer patients because faster biomarker results can help enable earlier treatment decisions and quicker access to appropriate targeted therapies. In precision oncology, reducing turnaround time is directly linked to earlier treatment initiation, and even a one-week improvement may substantially increase the likelihood of patients receiving recommended biomarker-guided therapy.
Results from rapid NGS are typically available in hours to a few days, depending on the number of samples being analyzed. In some cases, the full end-to-end workflow, from tissue or blood sample through extraction, quantification, library preparation, sequencing, and data analysis, can be completed in as little as next day. Because “rapid NGS” is sometimes used to describe only part of the workflow, it is important to confirm whether the stated time refers to sequencing alone or the full sample-to-result process.
Rapid NGS for solid tumor biomarker testing can be performed on tumor tissue samples, including small biopsies and cytology specimens, as well as liquid biopsy samples.
Rapid NGS differs from standard single-gene testing by analyzing many genes simultaneously rather than one mutation at a time, while delivering results much faster than standard NGS and often nearly as fast as single-gene tests. This combination of broad biomarker coverage and rapid turnaround makes rapid NGS a more efficient approach for identifying actionable biomarkers.
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References
1. Aggarwal C et al. (2023) Association between availability of molecular genotyping results and overall survival in patients with advanced nonsquamous non-small-cell lung cancer. JCO Precis Oncol 7:e2300191
2. Sadik M et al. (2022) Impact of clinical practice gaps on the implementation of personalized medicine in advanced non-small-cell lung cancer. JCO Precis Oncol 6:e2200246
3. Rolfo C et al. (2024) Maximising the synergy of tumour tissue and liquid biopsy testing in oncology clinical practice. EMJ Oncol 12(1):49–56.
4. Sheffield BS. 2022 Aug 3. Community-based rapid NGS offers considerable advantages in clinical cancer care [webinar]. CAP TODAY. Available from: https://players.brightcove.net/3663210762001/08UsfMRkC_default/index.html?videoId=6317107003112
5. Rice S. 2023 Oct. Fast or comprehensive? Lab offers both for NSCLC. CAP TODAY. Available from: https://www.captodayonline.com/fast-or-comprehensive-lab-offers-both-for-nsclc/
6. Allerton J. 2024 Dec. From NGS naive to fully accredited. The Pathologist. Available from: https://thepathologist.com/issues/2024/articles/dec/from-ngs-naive-to-fully-accredited
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