Next-Generation Sequencing (NGS) is a transformative technology for oncology molecular testing that allows clinicians to obtain a report with genomic data for a large number genes simultaneously from a single test.
Recent advances in NGS automation now allow hospitals to bring this valuable technology in-house, facilitating faster results and better coordination of care.
Despite the overwhelming need for NGS, many hospitals are reliant on outsourcing to specialized reference laboratories for this service, leading to long turnaround times for results, and potentially sub-optimal treatment regimens for cancer patients.
Rapid, in-house NGS can deliver benefits for patients, clinicians, and the overall hospital system.
Watch how NGS can help consolidate molecular testing in hemato-oncology
In a recent study of 525 non-small cell lung cancer (NSCLC) cases, patients who undergo biomarker testing and were treated with a biomarker-directed first-line treatment with a tyrosine kinase inhibitor (TKI) showed up to 35% higher probability of survival after two years than those who were put on a first-line chemotherapy and/or immunotherapy regimen in the absence of genomic profiling results.1
Patients who undergo biomarker testing and were treated with a biomarker-directed first-line TKI therapy also showed 22% higher probability of survival after 2 years relative to patients who were initially on a first-line chemotherapy and/or immunotherapy regimen and later switched to second-line TKI therapy after genomic profiling results were made available.
These findings suggest faster test results may provide clinicians the opportunity to choose optimal first-line therapy for those patients whose tumors harbor actionable genomic alterations.
Treatment regimens and apparent survival curves of NSCLC patients [1]. (A) Treatment regimens of the three groups. (B) Apparent survival curves of each group. Group B (n = 51), which switched to TKI treatment within 35 days, demonstrated a median apparent survival (AS) of 672 days. Group C (n = 90), which did not switch, demonstrated a median AS of 437 days. A median AS was not
reached for group A (control group, n = 384), because survival extended beyond the data cut-off date in more than half of patients.
With several mutation-targeted therapies available, and many more in pharmaceutical pipelines, rapid molecular testing can be valuable for informing front-line therapy section.
However, the common paradigm of limited single-gene testing followed by outsourced NGS testing often leads to extended time delays for results.
In some cases, oncologists must start patients on conventional therapies while they await the molecular report, which can lead to suboptimal outcomes.1
However, rapid in-house NGS testing can provide with a turnaround time of 3 days or less, helping to ensure that oncologists have the molecular report in time to inform the optimal front-line therapy decisions. 2
Modern cancer care relies heavily on biomarker testing for diagnosis and therapy. As the number of actionable biomarkers continues to increase, single-biomarkermarker testing is no longer practical.
Traditionally, each genetic biomarker requires an individual test, which rapidly depletes precious tissue samples, drives up cost, and increases time to results for all biomarkers being tested.
In-house NGS testing can allow labs to consolidate many single-gene tests, helping to speed up time to results.
Many hospitals outscore NGS testing to local reference laboratories, which can take up to 33 days to deliver results.1
In a recent study of 578 cases, a community hospital using an in-house NGS system was able to achieve a median turnaround time of only 2 days.2 Sixty-six (11%) of the reports were issued simultaneously with diagnosis.
This study demonstrated that fast NGS testing in-house with existing histopathology service can provide pathologists with genomic biomarker data in parallel to histologic diagnosis. So, physicians can make a quickly decision and give the optimal treatment for their patients.
The median turnaround time was 3 days. Molecular reports were delivered concurrently with histologic diagnosis in 66 of 578 cases (11%)
One study revealed success rates as low as 78% for hybrid capture–based NGS from a reference laboratory, due to sample constraints 3.
In contrast, a separate study of a laboratory using amplicon-based NGS cited a success rate of more than 94%4
With rapid NGS testing, patients may receive their diagnosis and start therapy sooner. As described in a recent presentation by Dr. David Swoboda of Tampa General Hospital, a reduction in the time to diagnosis may enable hospitals to reduce the average the duration of patients stays. This can translate to significant cost saving for patients and the health system, while freeing up hospital beds for others in need.
Watch Dr. Swoboda present a recent example for acute myeloid leukemia (AML) patients, describing how rapid NGS can significantly reduce the number of days from initial patient admission to eventual discharge.
Correct molecular diagnosis and treatment upfront
No treatment delays due to testing
No unnecessary outpatient treatment
Increased days outside of the hospital
Decreased days patient is in hospital
(cost reduction)
Decreased need for additional outpatient services
Better patient care and satisfaction
NGS testing is vital for delivering the promise of precision oncology to patients. But until recently, the technology was only practical for large institutions with specialized technicians and resources.
Recent advances in automation of NGS, however, now enable many more hospitals to cost-effectively bring NGS in house, without requiring additional FTEs or specialized training.
With broader access to NGS testing, more patients can experience modern precision oncology, regardless of where they seek care.
Hear from Dr. Brandon Sheffield, MD - Anatomic and Molecular Pathologist at William Osler Health System on the importance of in-house NGS.
"In-house, rapidly available gene sequencing technology greatly assists daily practice for oncologists, pathologists, surgeons, and others."
The Impact of NGS in Hematology-Oncology
Dr. Kojo Elenitoba-Johnson - Perelman School of Medicine at the University of Pennsylvania
"There are several protocols, including extensive amounts of genetics and immunophenotyping, which are required to establish the appropriate approach to treat patients. The sooner we can get results and deliver treatment, the better the outcomes."
The Role of Biomarker Testing in Treatment Decision Making: Current and Future Perspectives
Dr. Ahmad Awada - Jules Bordet Institute
"Currently, only about 10% of patients benefit from targeted therapy, but this varies according to the tumour. Testing is becoming increasingly available but access to targeted therapies is problematic. Physicians are already asking for more biomarker analysis and this trend will continue."
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References
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