ASCP, CAP, AMP, and ASCO Issue Draft Colorectal Cancer Molecular Marker Testing Guideline and Announce Opening of Public Comment Period

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Multi-Disciplinary Guidance Document Focuses on Using Molecular Markers to Optimize Patient Care

By bringing together four key organizations, all with substantial interest in treatment of colorectal cancer, we have addressed multiple elements of the patient care continuum.

The American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) today released a draft of a clinical practice guideline on the use of molecular marker testing for patients with primary or metastatic colorectal carcinoma. This evidence-based guideline will help establish standard molecular marker testing, guide targeted therapies, and advance personalized care for these patients. The draft guidance document, “Guideline on the Evaluation of Molecular Markers for Colorectal Cancer Workgroup Draft Recommendations Summary,” (#CRCOCP) is now available online for public comment through April 22, 2015.

The draft guidance is designed to identify opportunities for improving patient outcomes. “By bringing together four key organizations, all with substantial interest in treatment of colorectal cancer, we have addressed multiple elements of the patient care continuum,” said Wayne W. Grody, MD, PhD, UCLA School of Medicine, project co-chair on behalf of ASCP. “While we didn't focus on a selected set of molecular markers, we considered the overall plan-of-care from collection of tissue samples to diagnostics, treatment, and follow-up.”

The co-chairs, one from each of the four organizations, utilized the expertise of more than 25 specialists in a variety of disciplines, including pathologists and oncologists as well as patient advocates, to draft the guidance document. The multi-disciplinary perspective has resulted in a thorough set of draft recommendations that streamline processes and contribute to improving patient outcomes. “While other colorectal cancer biomarker guidelines have been published, they tend to focus on one marker or a small panel of markers for one specific clinical use, unlike the collaborative multidisciplinary approach for this guideline,” said Stanley R. Hamilton, MD, FCAP, AGAF, The University of Texas MD Anderson Cancer Center, project co-chair on behalf of CAP. “This guideline addresses all current molecular markers that can impact treatment decisions for patients with colorectal cancer. To date, there isn't an evidence-based guideline that’s quite as all-encompassing and patient-centered as this one.”

Input from stakeholders, including scientists, clinicians, government agencies, other non-profit organizations, patients, patient advocates, and members of the public is critical to the release of a final set of recommendations for the care of patients with colorectal cancer. “Anyone who may be affected by or play a role in the application of the guideline is encouraged to provide comments,” said Antonia R. Sepulveda, MD, PhD, FASCP, FCAP, Columbia University, project co-chair on behalf of AMP. “From the onset, we have adhered to the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines, which includes a dedicated external review period.”

The final guidance document is targeted for publication later this year. “Given the rapid evolution of the field, we have ‘future proofed’ the document with a research section that acknowledges molecular markers and tests on the horizon,” said Carmen Allegra, MD, University of Florida Health Cancer Center, project co-chair on behalf of ASCO. “We intend to review these recommendations regularly and will update the guidance document as necessary.”

Editor’s Note:
The draft recommendations and references provided here represent time-limited information and are not to be distributed, used, or considered as an accurate representation of the Colorectal Cancer Molecular Marker Guideline group's work product(s) after April 22, 2015.

About the American Society for Clinical Pathology:
Founded in 1922 in Chicago, ASCP unites more than 120,000 anatomic and clinical pathologists, residents and fellows, medical laboratory professionals and students to accelerate the advancement of laboratory medicine to better improve patient care through knowledge, collaboration and global community. ASCP’s mission is to provide excellence in education, certification, and advocacy on behalf of the patients, pathologists, and laboratory professionals across the globe. To learn more, visit http://www.ascp.org. Follow us on Twitter at http://www.twitter.com/ascp_chicago and connect with us on Facebook at http://www.facebook.com/ASCP.Chicago.

About the College of American Pathologists
As the leading organization with more than 18,000 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. The CAP’s Laboratory Improvement Programs, initiated 65 years ago, currently has customers in more than 100 countries, accrediting 7,600 laboratories and providing proficiency testing to 20,000 laboratories worldwide. Find more information about the CAP at cap.org. Follow CAP on Twitter: @pathologists.

About the Association for Molecular Pathology
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 policy and regulation 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 http://www.amp.org. Follow AMP on Twitter: @AMPath.

About The American Society of Clinical Oncology:
Founded in 1964, the American Society of Clinical Oncology (ASCO) is the world's leading professional organization representing physicians who care for people with cancer. With more than 35,000 members, ASCO is committed to improving cancer care through scientific meetings, educational programs and peer-reviewed journals. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation, which funds ground-breaking research and programs that make a tangible difference in the lives of people with cancer. For ASCO information and resources, visit http://www.asco.org. Patient-oriented cancer information is available at http://www.cancer.net.

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Pam Flores
American Society for Clinical Pathology
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