The College of American Pathologists (CAP) has issued new evidence-based guidelines for lung cancer testing and for the validation of whole slide imaging.
CAP joined with the International Association for the Study of Lung Cancer and the Association for Molecular Pathology to create evidence-based guidelines for lung cancer testing, while it compiled the whole slide imaging in-house.
The lung cancer guidelines include recommendations for two genetic-based tests for lung cancer. They include testing for mutations of the epidermal growth factor receptor, or EGFR, and the rearrangement of the anaplastic lymphoma kinase, or ALK. Both are considered reliable markers for lung cancer in molecular testing.
Officials say testing for these two biomarkers would make it easier to craft more effective therapies for treating the disease.
Lung cancer is the deadliest form of cancer in the United States, killing more than 160,000 Americans a year. Although the death rate has plateaued among men in recent years, the death rate for women continues to rise. More than 225,000 new cases are diagnosed annually. The five-year survival rate is just over 16 percent.
“Up to 20 percent of patients with lung adenocarcinoma, the most common type of lung cancer, will test positive for one of the two biomarkers,” said Philip T. Cagle, M.D., medical director of pulmonary pathology in the department of pathology and genomic medicine at Methodist Hospital in Houston. “It is critical to identify these patients because they stand to benefit more from new targeted drugs than from conventional chemotherapy, and with fewer side effects.”
CAP’s pathology and laboratory quality center provided the process for creating the guidelines. The three organizations have also developed clinical tools and resources for pathologists and oncologists that distill the findings and recommendations.
Whole Slide Imaging Validation
The guidelines for whole slide imaging were developed to help pathologists and laboratories seeking confirmation for the accuracy of their imaging systems for the sake of diagnostics. Whole slide imaging allows practices and labs to digitize and archive images and use computer-aided diagnostic tools.
The guidelines include 12 recommendations, among them creating a validation process that emulates the clinical environment of the laboratory, using at least 60 routine cases for validation, and confirming that all material on the slide that has been scanned is included in the digital image.
“We developed the guideline in anticipation of wider adoption of WSI in clinical practice,” said Liron Pantanowitz, M.D., associate professor in the pathology and biomedical informatics at the University of Pittsburgh and the lead author of the guideline. “The guideline marks a significant stepforward in demonstrating the value of this emerging technology for diagnostic use.”
The Food and Drug Administration has not yet approved whole slide imaging for primary diagnoses, but the guidelines can be used for pathologists practicing abroad, according to CAP. Pathologists in the United States primarily use whole slide imaging for teaching, research, and remote consultations.
The lung cancer and whole slide imaging guidelines are available on the Web site of the
Archives of Pathology & Laboratory Medicine at
www.archivesofpathology.org.
