College of American Pathologists

  News Release


Published on May 30, 2013

Contact: Julie Monzo
Phone: 800-323-4040, ext. 7538

Leading Health Care Organizations Present Evidence-Based Guideline Recommendations for Molecular Testing of Lung Cancer to Direct EGFR- and ALK-Directed Therapies at the American Society of Clinical Oncology 2013 Annual Meeting

Northfield, IL—The College of American Pathologists (CAP) has partnered with the International Association for the Study of Lung Cancer (IASLC) and the Association for Molecular Pathology (AMP) to establish evidence-based guideline recommendations for the molecular analysis of lung cancers required to guide EGFR- and ALK-targeted therapies.

The guideline recommendations will be presented at the American Society of Clinical Oncology (ASCO) annual meeting on Monday, June 3 in Chicago.

Molecular Testing Guideline for the Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors,”

  • Abstract #11085, General Poster Session (Board #48H) Tumor Biology category
  • Monday, June 3, 1:15 p.m. – 5:00 p.m.

“The key recommendation of the guideline, and perhaps most important to lung cancer patients, is that all patients with advanced lung adenocarcinoma should be tested for EGFR and ALK abnormalities, that would qualify them for tyrosine kinase inhibitor therapy, regardless of their clinical variables, such as smoking history, gender, or ethnicity,” said Marc Ladanyi, MD, FCAP, attending pathologist in the Molecular Diagnostics Service at Memorial Sloan-Kettering Cancer Center in New York, and one of the lead guideline authors.

The guideline answers important clinical questions, including:

  • When should testing be performed?
  • How should testing be performed?
  • Should other genes be routinely tested in lung cancer?
  • How should molecular testing of lung cancer be implemented?

In addition, the guideline authors concluded that EGFR and ALK testing should be prioritized over other molecular predictive tests.

Lung cancer is the number one cancer killer in the United States and abroad. In the U.S., it is estimated that approximately 20 percent of patients with lung adenocarcinoma, the most common type of lung cancer, will test positive for one of the two biomarkers. The evidence-based guideline will help to identify these patients who stand to benefit more from new targeted drugs than from conventional chemotherapy, and with fewer side effects.

“Now, for the first time after a decade of biomarker testing in lung cancer, a uniform approach for testing for the EGFR mutation and ALK rearrangement along with the availability of targeted therapies offer lung cancer patients the chance for improved survival and better quality of life,” said Dr. Ladanyi.

In an era of precision medicine, the guideline provides recommendations for pathologists, oncologists, and other cancer health professionals on the current state-of-the-art in the molecular testing of lung cancer.

“As new studies lead to further evidence-based recommendations, we hope to develop additional guidelines for other biomarkers related to this disease,” said Dr. Ladanyi.

The CAP Pathology & Laboratory Quality Center (the Center), a forum for developing evidence-based guidelines and consensus recommendations, provided the process for creating the guideline. An expert panel made up of renowned worldwide leaders in the field collaborated to develop the recommendations.

In conjunction with the publishing of the guideline, CAP, IASLC, and AMP have developed clinical tools and resources for pathologists and oncologists that summarize the findings and recommendations. In addition, the organizations have developed a patient guide for further understanding, including questions for patients to ask their physicians. A series of videos featuring three of the guideline authors and a lung cancer survivor can be found on the CAP, IASLC, and AMP YouTube Channels.

The guideline was released on April 3, 2013, in the online editions of Archives of Pathology & Laboratory Medicine (APLM), Journal of Thoracic Oncology, and The Journal of Molecular Diagnostics.

About the College of American Pathologists

As the leading organization for board-certified pathologists, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. With more than 18,000 physician members, the CAP has led as the gold standard in laboratory accreditation for 50 years with more than 7,300 CAP-accredited laboratories in 50 countries. Find more information about the CAP at