Integration of rapid PCR testing as an adjunct to NGS in diagnostic pathology services within the UK: evidence from a case series of non-squamous, non-small cell lung cancer (NSCLC) patients with follow-up

Abstract

AimsSomatic genetic testing in non-squamous, non-small cell lung carcinoma (NSCLC) patients is required to highlight subgroups eligible for a number of novel oncological therapies. This study aims to determine whether turnaround times for reporting epidermal growth factor receptors (EGFR) by next-generation sequencing (NGS) alone is sufficient to meet the needs of lung cancer patients.MethodsWe performed a retrospective case series with follow-up. Outcomes of EGFR testing (102 tests) in 96 patients by NGS were compared with a rapid, fully automated PCR-based platform (Idylla) in local histopathology laboratories.ResultsTurnaround time for reporting NGS was 17 calendar days. Reporting using the Idylla EGFR Mutation Test, by contrast, gave a potential turnaround time of 3.8 days from request to authorisation. Three-quarters of patients presenting with stage IV disease had a performance status of 0, 1, or 2 but 18% experienced rapid clinical deterioration (p<0.05). A third of these patients were deceased by the time NGS reports were available.ConclusionsWe discuss issues around integrating rapid PCR testing alongside NGS in multidisciplinary care pathways and strategies for mitigating against foreseeable difficulties. Dual testing for stage IV non-squamous, NSCLC patients has the potential to improve care and survival outcomes by providing access to the right test at the right time.

Referred molecular testing as a barrier to optimal treatment decision making in metastatic non‐small cell lung cancer: Experience at a tertiary academic institution in Canada

“…Our shorter in-house TATs may be attributed in part to faster testing methods, specifically our in-house qPCR assay which no longer required 2 days of DNA extraction prior to testing. 29 Nonetheless, even if the same assays were used, our final hypothetical in-house TAT of 5 days would still be shorter than the 8 day send-out TAT. This suggests that TAT is influenced by factors beyond testing method which may include lower backlogs of specimens requiring analysis with in-house as compared to send-out, centralized testing.…”

“…Our results show that in‐house biomarker testing has the potential for even faster TATs (median, 3 days with 96% of cases ≤10 day TAT). Our shorter in‐house TATs may be attributed in part to faster testing methods, specifically our in‐house qPCR assay which no longer required 2 days of DNA extraction prior to testing 29 . Nonetheless, even if the same assays were used, our final hypothetical in‐house TAT of 5 days would still be shorter than the 8 day send‐out TAT.…”

Integrated Radiology, Pathology, and Pharmacy Program to Accelerate Access to Osimertinib

“…However, we envision that the increasing interest in rapid workflows and novel testing platforms will soon enable broader adoption of rapid testing paradigms. 11,12 Second, because of variability in patient circumstances (including insurance coverage, the plan-based benefit structure, and financial resources), some patients still experienced a delay between the identification of the EGFR mutation and initiation of osimertinib, particularly patients who required co-pay assistance and enrollment in free drug programs. This suggests that complex external factors continue to pose hurdles to ensuring that all patients receive timely, molecularly informed treatment for their cancer irrespective of their social circumstances.…”

Improving care of melanoma patients through efficient, integrated cellular-molecular pathology workflows using tissue samples with low tumour nuclear content

“…The Idylla platform was selected with this in mind. The cartridge format and automated DNA extraction means that it only takes 2–3 min of biomedical scientist (BMS) time to perform the test 13…”

“…Patients can have profound clinical response within days and therefore knowing the BRAF status and being able to start BRAF directed therapy can make the difference between life and death. There is clear, real-world evidence from the setting of lung cancer that delays in somatic mutation testing can lead to missed opportunities for treatment intervention 13…”