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Vol. 215. Issue 9.
Pages 527-536 (December 2015)
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Vol. 215. Issue 9.
Pages 527-536 (December 2015)
Review
A systematic review of the clinical validity of the Cologuard™ genetic test for screening colorectal cancer
Validez clínica de la prueba genética Cologuard™ para el cribado de cáncer colorrectal: revisión sistemática
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M.Á. Onieva-Garcíaa,
Corresponding author
mariaa.onieva@gmail.com

Corresponding author.
, A. Llanos-Méndezb, E. Baños-Álvarezb, R. Isabel-Gómezb
a UGC Interniveles de Salud Pública de Granada, Spain
b Agencia de Evaluación de Tecnologías Sanitarias de Andalucía, Consejería de Salud de la Junta de Andalucía, Sevilla, Spain
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Figures (2)
Tables (4)
Table 1. Characteristics of the study population.
Table 2. Efficacy results in terms of diagnostic validity.
Table 3. Results of sensitivity for detecting colorectal cancer lesions.
Table 4. Results of Sensitivity for detecting advanced precancerous lesions.
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Abstract
Objectives

The aim of this study was to assess the available evidence on the validity, diagnostic accuracy and clinical utility of the multitarget DNA test in feces (Cologuard™) for screening for colorectal cancer (CRC).

Material and methods

A systematic review was performed by consulting MedLine, EMBASE and Web of Science to July 2014. Studies on diagnostic tests were selected that evaluated the test in asymptomatic adults who underwent CRC screening. The quality and risk of bias were assessed using the Quality Assessment of Diagnostic Accuracy Studies tool. The level of evidence was defined according to the National Institute for Health and Clinical Excellence. A qualitative synthesis was conducted.

Results

A total of 299 literature references were identified, including 1 synthesis report and 5 diagnostic test studies. Three of the five studies had a case-control design in Sackett phase II and were of moderate quality, and two had a prospective design in Sacket phase III and were of high quality. The sensitivity for detecting CRC was greater than 90%, but only 40% for detecting advanced adenomas. The test provided conclusive diagnostic evidence to rule out CRC (negative likelihood ratio, LR−: 0.02–0.09), although it was not useful for ruling out advanced adenoma (LR−: 0.5–0.7).

Conclusions

The Cologuard™ test is a valid screening test for ruling out cancerous lesions but is suboptimal for ruling out precancerous lesions. There is no evidence in terms of mortality, survival or cost-effectiveness.

Keywords:
Systematic review
Colorectal cancer
Screening
Analysis of DNA mutations
Feces
Resumen
Objetivos

El objetivo fue evaluar la evidencia disponible sobre la validez, precisión diagnóstica y utilidad clínica del test multidiana de ADN en heces (Cologuard™) en el cribado de cáncer colorrectal (CCR).

Material y métodos

Se realizó una revisión sistemática consultando MedLine, EMBASE y Web of Science hasta julio de 2014. Se seleccionaron estudios de pruebas diagnósticas que evaluaran el test en adultos asintomáticos sometidos a cribado de CCR. La calidad y el riesgo de sesgo se evaluaron mediante la herramienta Quality Assessment of Diagnostic Accuracy Studies. El nivel de evidencia se definió según The National Institute for Healthand Clinical Excellence. Se realizó una síntesis cualitativa.

Resultados

Se identificaron 299 referencias bibliográficas, incluyéndose un informe de síntesis y cinco estudios de pruebas diagnósticas, tres de ellos con diseño caso-control en fase II de Sackett y de moderada calidad, y dos con diseño prospectivo en fase III de Sacket y de alta calidad. La sensibilidad para detectar CCR fue superior al 90%, pero solo del 40% para la detección de adenoma avanzado. El test proporcionó evidencia diagnóstica concluyente para descartar CCR (cociente de probabilidad negativo, CPN: 0,02-0,09), aunque no fue útil para descartar adenoma avanzado (CPN: 0,5-0,7).

Conclusiones

El test Cologuard™ es una prueba de cribado válida para descartar lesiones cancerosas, resultando subóptima para descartar lesiones precancerosas. No hay evidencia sobre resultados en términos de mortalidad o supervivencia, ni sobre coste-efectividad.

Palabras clave:
Revisión sistemática
Cáncer colorrectal
Cribado
Análisis de mutaciones de ADN
Heces

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