Molecular Testing Turnaround Time for Non–Small Cell Lung Cancer in Routine Clinical Practice Confirms Feasibility of CAP/IASLC/AMP Guideline Recommendations: A Single-center Analysis

DiStasio, Marcello; Chen, Yigu; Rangachari, Deepa; Costa, Daniel B.; Heher, Yael K.; VanderLaan, Paul A.

doi:10.1016/j.cllc.2017.03.001

Cited by 33 publications

(34 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…When relying on a reference send‐out laboratory for ancillary testing, a shared responsibility exists for oversight of pre‐analytic factors leading to error. The perceived testing time by the clinician awaiting results is impacted not only by the reference laboratory TAT, but also by delays at the front end (time from test ordering to specimen arriving at reference laboratory) and at the back end (time from reference laboratory reporting to results available to clinicians) . Whereas the timing and quality measures taken by the reference laboratory are beyond the control of a given cytopathology laboratory, the front end and back end processes should be evaluated for maximal efficiency and reporting accuracy.…”

Section: Send‐out Testing: a Growing Quality And Safety Riskmentioning

confidence: 99%

“…The perceived testing time by the clinician awaiting results is impacted not only by the reference laboratory TAT, but also by delays at the front end (time from test ordering to specimen arriving at reference laboratory) and at the back end (time from reference laboratory reporting to results available to clinicians). 12 Whereas the timing and quality measures taken by the reference laboratory are beyond the control of a given cytopathology laboratory, the front end and back end processes should be evaluated for maximal efficiency and reporting accuracy. A summary of the risks associated with send-out reference laboratory testing are summarized in Figure 4; this summary is somewhat more applicable to a laboratory that sends out the specimen for testing than a reference laboratory that receives the specimens and performs the testing.…”

Section: Send-out Testing: a Growing Quality And Safety Riskmentioning

confidence: 99%

See 1 more Smart Citation

Pre‐analytic error: A significant patient safety risk

Heher

Chen

VanderLaan

2018

Cancer Cytopathology

Self Cite

View full text Add to dashboard Cite

Ancillary testing in cytopathology has grown dramatically over the past decade, enhancing the clinical value of cytology specimens obtained via minimally invasive methods. However, a complex testing landscape brings with it new and emerging risks to patient safety. Recognition of complicated systems issues as well as shared responsibility in process ownership can help to minimize safety risks. Because pre-analytic factors account for the majority of errors in pathology, attention to operational steps (test ordering, specimen collection, specimen transport, specimen accessioning, and specimen processing) is critical for successful quality improvement programs. With increasing technical costs and complexity of many ancillary molecular tests, a growing trend toward send-out testing to centralized reference laboratories poses additional patient safety risks. Given these new realities in cytopathology ancillary testing, a collaborative, team-based approach with all process stakeholders is needed to improve pre-analytic processes, reduce error risk, and enhance patient safety.

show abstract

Section: Send‐out Testing: a Growing Quality And Safety Riskmentioning

confidence: 99%

Section: Send-out Testing: a Growing Quality And Safety Riskmentioning

confidence: 99%

Pre‐analytic error: A significant patient safety risk

Heher

Chen

VanderLaan

2018

Cancer Cytopathology

Self Cite

View full text Add to dashboard Cite

show abstract

“…11 Additionally, a third of patients may have biopsies with insufficient tumor tissue for molecular studies. 18 In such a scenario, cytology, especially fine-needle aspiration (FNA), is placed at the front line in the management of patients with NSCLC. In this review, we describe the use of cytology samples, especially direct smears, in molecular studies, including epidermal growth factor receptor (EGFR), KRAS, and BRAF mutational testing; ALK and ROS1 fluorescence in situ hybridization (FISH) testing; NGS; PD-L1 IHC; and DNA methylation detection.…”

mentioning

confidence: 99%

Cytology Smears in the Era of Molecular Biomarkers in Non–Small Cell Lung Cancer: Doing More With Less

Lozano¹,

Echeveste²,

Abengózar³

et al. 2018

Archives of Pathology &Amp; Laboratory Medicine

View full text Add to dashboard Cite

- Molecular testing can be performed on cytologic specimens, especially on direct smears. Rapid on-site evaluation by cytopathologists has improved the adequacy and the management of cytology samples for molecular testing. Mutational profiling of NSCLC using next-generation sequencing can be performed on cytology samples from very small amounts of DNA. Fluorescence in situ hybridization assays on cytology specimens, including stained direct smear, offer some distinct advantages over their histologic counterpart, and are used to detect ALK and ROS1 rearrangements in NSCLC. Cytology specimens allow assessment of the entire tumor cell nucleus, avoiding signal loss from truncation artifacts. The use of cytology samples for assessing programmed death ligand-1 protein expression is currently being developed. Protocols for bisulfite conversion and DNA droplet digital polymerase chain reaction assays have been optimized for cytology smear to investigate aberrant DNA methylation of several NSCLC-related genes.

show abstract

“…In this regard, the international guidelines for the turnaround time to obtain results, most notably for EGFR status, were not followed consistently for all patients. 33,34 As such, the delay in responses was not compatible with the adapted caregiving of NSCLC patients, specifically in the case of rapid tumor progression. 35 For this reason, a number of laboratories have set up a double circuit, one using a rapid process with specific PCR-based techniques (COBAS, Biocartis, laboratory-developed tests) and the second one using gene panel assessment by NGS.…”

Section: Current Functioning: a New Funding Systemmentioning

confidence: 96%

Predictive molecular pathology in non–small cell lung cancer in France: The past, the present and the perspectives

Hofman

Rouleau

Sabourin

et al. 2020

Cancer Cytopathology

View full text Add to dashboard Cite

The advent of molecular targets for novel therapeutics in oncology, notably for non–small cell lung carcinoma (NSCLC), led the French National Cancer Institute (INCa) to establish a national network of 28 hospital Molecular Genetics Centers for Cancer (MGCC) in 2007. In each University in France, laboratories were established to develop molecular biology testing to evaluate a few genomic alterations, initially a selection of genes, by using specific targeted polymerase chain reaction (PCR) assays. In a second phase, the number of studied genes was increased. In 2015, the MGCC benefited from an additional dedicated budget from the INCa to develop next‐generation sequencing (NGS) technology. In the meantime, a new financial regulation for innovative testing has been established for the acts out of nomenclature. Consequently, all private and public laboratories in France have access to funding for molecular biology testing in oncology. The gene‐based PCR assays or NGS tests have benefitted from reimbursement of cost testing by the INCa. Today, the laboratories consider this reimbursement to be only partial, and its use to be complex. In 2018, a strategic plan for medical genomic analyses (France Médecine Génomique 2025) was implemented to introduce more systematic sequencing into the health care pathway and oncology practice. The large panel of molecular tests should be centralized to a limited number of molecular genetic centers. This review describes the evolution of the different stages of implementation of molecular pathology testing for NSCLC patients over the last few years in France.

show abstract

Molecular Testing Turnaround Time for Non–Small Cell Lung Cancer in Routine Clinical Practice Confirms Feasibility of CAP/IASLC/AMP Guideline Recommendations: A Single-center Analysis

Cited by 33 publications

References 5 publications

Pre‐analytic error: A significant patient safety risk

Pre‐analytic error: A significant patient safety risk

Cytology Smears in the Era of Molecular Biomarkers in Non–Small Cell Lung Cancer: Doing More With Less

Predictive molecular pathology in non–small cell lung cancer in France: The past, the present and the perspectives

Contact Info

Product

Resources

About