Jennifer Clark

Molecular biomarkers for the evaluation of colorectal cancer: Guideline from The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology

Purpose Molecular testing of colorectal cancers (CRCs) to improve patient care and outcomes of targeted and conventional therapies has been the center of many recent studies, including clinical trials. Evidence-based recommendations for the molecular testing of CRC tissues to guide epidermal growth factor receptor (EGFR) -targeted therapies and conventional chemotherapy regimens are warranted in clinical practice. The purpose of this guideline is to develop evidence-based recommendations to help establish standard molecular biomarker testing for CRC through a systematic review of the literature. Methods The American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to develop an evidence-based guideline to help establish standard molecular biomarker testing, guide targeted therapies, and advance personalized care for patients with CRC. A comprehensive literature search that included over 4,000 articles was conducted to gather data to inform this guideline. Results Twenty-one guideline statements (eight recommendations, 10 expert consensus opinions and three no recommendations) were established. Recommendations Evidence supports mutational testing for genes in the EGFR signaling pathway, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize molecular testing for predictive and prognostic molecular biomarkers involve selection of assays, type of specimens to be tested, timing of ordering of tests and turnaround time for testing results. Additional information is available at: www.asco.org/CRC-markers-guideline and www.asco.org/guidelineswiki.

Thyroid fine-needle aspiration cytology: performance data of neoplastic and malignant cases as identified from 1558 responses in the ASCP Non-GYN Assessment program thyroid fine-needle performance data.

Fine‐needle aspiration of the thyroid is a common procedure, with an established role in reducing unnecessary thyroid surgery and identifying neoplasms and malignancies.

Molecular biomarkers for the evaluation of colorectal cancer: Guideline from the American society for clinical pathology, college of American pathologists, association for molecular pathology, and American society of clinical oncology

OBJECTIVES - To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. METHODS - The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. RESULTS - Twenty-one guideline statements were established. CONCLUSIONS - Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented.

Molecular Biomarkers for the Evaluation of Colorectal Cancer

Abstract Objectives: To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. Methods: The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. Results: Twenty-one guideline statements were established. Conclusions: Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented.

Changing Practice Patterns for Cytotechnologists: A Comparative Analysis of Data from the 2009 and 2015 ASCP BOC Practice Analysis Surveys

Background The American Society for Clinical Pathology (ASCP) Board of Certification (BOC) surveys US certified cytotechnologists (CTs) at approximately 5-year intervals to gain information about current practice patterns. Although the purpose of this survey is to inform valid content development for the BOC CT examination, comparative longitudinal analysis of the survey data provides information about changes in cytotechnology practice. Materials and Methods BOC Practice Analysis Survey data for 2009 and 2015 were examined, comparing survey demographics and performance of laboratory tasks. The 2015 survey added tasks not previously surveyed and considered them emerging when performed by a majority of respondents. Results Two hundred thirty-five participants completed the survey in 2015 and 151 in 2009. Respondents reported an overall decrease in performing conventional Papanicolaou tests (-25.3%). Respondents reported increases in morphologic tasks such cytologyehistology correlation (17.5%), cell-block interpretation (17.5%), and preliminary interpretation of histochemical stains (e.g., mucin and Grocotts methenamine silver stain) (16.7%), as well as quality assurance tasks. Majority-performed, newly surveyed tasks included touch prep preparation (57.8%) and interpretation (59.2%) and ancillary test triage (59.6%). Molecular tasks such as tumor identification (6.8%) and preparation of cytology specimens for oncology molecular testing (9.4%) did not meet majority reporting thresholds. Conclusions Although performance of the Papanicolaou test is declining, CTs report increases in additional morphologic as well as other laboratory tasks. Emerging tasks (2015) focus on FNA specimens. Knowledge of cytology practice patterns will help guide development of education and training resources toward maintaining an appropriately trained workforce.