International Lung Cancer Experts Seek Public Comments On Revised Molecular Testing Guideline To Improve Patient Selection And Targeted Therapies

Contact: Kerry Lydon
Phone: 800-323-4040 ext. 7844
E-mail: MEDIA@CAP.ORG

Northfield, IL—The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) announced today the open comment period for the revised evidence-based guideline, "Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors."

The Open Comment Period begins today and will close on August 2, 2016. The online format provides an opportunity for public review of new draft recommendations for several key topics, as well as recommendation statements that have been reaffirmed since the initial guideline was jointly published online in April 2013 by Archives of Pathology & Laboratory Medicine, The Journal of Thoracic Oncology, and The Journal of Molecular Diagnostics.

"In an era of precision medicine, our collective ability to not only understand but leverage the latest breakthroughs in lung cancer research will enable us to provide more precise targeted treatment options. The revised guideline provides a clear framework based on evidence from recently published clinical literature," said Philip T. Cagle, MD, FCAP, medical director of pulmonary pathology in the Department of Pathology and Genomic Medicine at Houston Methodist Hospital, editor-in-chief of Archives of Pathology & Laboratory Medicine, and CAP member.

The guideline revisions are designed to provide state-of-the-art molecular testing of lung cancer recommendations for pathologists, oncologists, and other cancer and molecular diagnostic laboratory professionals. The revisions are all based on evidence from an unbiased review of published experimental literature since 2013 and include the recommendations from an expert panel of renowned worldwide leaders in the field. The final recommendations will be approved and jointly published after consideration of the public comments, further panel discussion, and a complete evidence analysis.

"The revised guideline reinforces the importance of molecular testing, establishes molecular testing standards, and helps guide targeted therapies for lung cancer," said Yasushi Yatabe, MD, PhD, chief of the Department of Pathology and Molecular Diagnostics at Aichi Cancer Center in Nagoya, Japan, and IASLC member. "We strongly encourage our peers to provide feedback to ensure our draft recommendations are sound, practical, and implementable, so we can all support best clinical practices and provide optimal care to our patients."

"The final manuscript will serve as both an update and extension of the 2013 practice guideline that established evidence-based identification and best practices for molecular biomarker testing for patients diagnosed with non-squamous, non-small cell lung cancer of all stages," said Neal I. Lindeman, MD, director of Molecular Diagnostics Laboratory at Brigham and Women's Hospital, associate professor of pathology at Harvard Medical School, and AMP member. "This guideline will continue to be updated as appropriate, and guidelines for other biomarkers associated with lung cancer will be added as more research becomes available."

Together with a multi-disciplinary expert panel, Co-chairs Cagle, Yatabe, and Lindeman formulated new draft recommendations addressing these key questions:

• What other genes, previously not addressed, should be tested in lung adenocarcinoma?
• Is immunohistochemistry reliable for screening for ALK translocations?
• What are the types and rates of secondary resistance in patients who are undergoing treatment with targeted tyrosine kinase inhibitors?
• What are the clinical performance characteristics of circulating DNA/CTC in plasma when used for diagnosis of primary lung adenocarcinoma or relapse?
• Are there biomarkers that are predictive of clinical outcome in squamous and small cell lung carcinomas?
• What key considerations are there regarding next-generation sequencing panels targeting key genes or regions of interest?

In conjunction with revising the guideline, CAP, IASLC, and AMP will develop clinical tools and resources for pathologists and oncologists that summarize the findings and recommendations. The organizations expect to develop a patient guide for further understanding, including questions for patients to ask their physicians.

About the College of American Pathologists

As the leading organization of 18,000 board-certified pathologists, the CAP serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The CAP's Laboratory Improvement Programs, initiated 65 years ago, currently has customers in more than 100 countries, accrediting 7,800 laboratories and providing proficiency testing to 20,000 laboratories worldwide. Find more information about the CAP at CAP.ORG. Follow CAP on Twitter at @PATHOLOGISTS.

About the International Association for the Study of Lung Cancer (IASLC)

The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated to the study of lung cancer. Founded in 1974, the association's membership includes more than 5,000 lung cancer specialists in over 100 countries. IASLC members promote the study of etiology, epidemiology, prevention, diagnosis, treatment and all other aspects of lung cancer and thoracic malignancies. IASLC brings scientists, members of the medical community and the public together from all over the world to share best practices and discover new and better ways to eliminate the health threat of thoracic cancers. Membership is open to any physician, scientist, nurse or allied health professional interested in lung cancer and other thoracic malignancies, including patients, survivors, caregivers, and advocates. Visit WWW.IASLC.ORG for more information and follow us on Twitter @IASLC.

About the Association for Molecular Pathology (AMP)

The Association for Molecular Pathology (AMP) was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP's 2,300+ members include individuals from academic and community medical centers, government, and industry; including pathologist and doctoral scientist laboratory directors; basic and translational scientists; technologists; and trainees. Through the efforts of its Board of Directors, Committees, Working Groups, and members, AMP is the primary resource for expertise, education, and collaboration in one of the fastest growing fields in healthcare. AMP members influence clinical practice, education, and policy on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high quality, appropriate testing. For more information, visit WWW.AMP.ORG ;and follow us on Twitter at @AMPATH.