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Diagnostics Regulation and standards, Oncology, Biochemistry and molecular biology

Hitting the Mark

Draft guidelines designed to address the evaluation of molecular markers in colorectal cancer (CRC) have been released by a partnership of US pathology and oncology societies (1). The group hopes that the multidisciplinary guidance will provide useful recommendations on everything from sample collection to diagnostics and follow up, with a stated aim of improving and optimizing personalized care for patients.

Sponsored by 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), each society was represented by a co-chair. A panel of over 25 different experts in oncology and pathology was also involved – a truly collective effort.

So why were the guidelines needed? “While other CRC 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,” says Stanley Hamilton, the CAP co-chair of the project. “This guideline addresses all current molecular markers that can impact treatment decisions for patients with CRC. To date, there isn’t an evidence-based guideline that’s quite as all-encompassing and patient-centered as this one.”

The document provides guidance for pathologists on which molecular markers to use for which patients (see Table 1), as well as recommendations on appropriate sampling and testing methods, turnaround times, and test prioritization.

Table 1. Recommendations made by the ASCP/CAP/AMP/ASCO guidelines on which molecular marker tests should be performed on patients with CRC.

The draft guidelines were made available online from March 30 to April 22, 2015, in order to allow comments from the healthcare community, with feedback welcomed.

The guidelines also acknowledged testing methods still under development; “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. We intend to review these recommendations regularly,” says ASCO co-chair, Carmen Allegra.

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  1. American Society for Clinical Oncology, “ASCP, CAP, AMP, and ASCO Issue Draft Colorectal Cancer Molecular Marker Testing Guideline and Announce Opening of Public Comment Period”, (2015). Accessed April 16, 2015.
About the Author
Roisin McGuigan

I have an extensive academic background in the life sciences, having studied forensic biology and human medical genetics in my time at Strathclyde and Glasgow Universities. My research, data presentation and bioinformatics skills plus my ‘wet lab’ experience have been a superb grounding for my role as an Associate Editor at Texere Publishing. The job allows me to utilize my hard-learned academic skills and experience in my current position within an exciting and contemporary publishing company.

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