Clinical OMICS

JUL-AUG 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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6 Clinical OMICs July/August 2019 News AMP Adds Conditions to Support of Consumer Genomic Tests The Association for Molecular Pathology (AMP) has expanded its set of conditions it wants met before it will support a clini- cally meaningful consumer genomic test. AMP said its expanded set of conditions are intended to reflect the range of currently available technologies, highlight privacy best practices, and encourage consumers to consult with their healthcare providers before making clinical care decisions. AMP's expanded set of conditions include: • All health-related claims must have well-established clinical validity. • The consumer genomic testing provider must comply with the CLIA statute and regulations. Test validation and interpreta- tion should be performed by board-certified molecular labora- tory professionals. • Information regarding the analyti- cal and clinical validity of the tests should be present in all marketing materials and included in each report of results. • The consumer genomic test report should be in lay language and describe the limitations of the test, an interpretation of the finding(s) and significance for the consum- er's health status, as well as impli- cations for family members. • Test providers should adhere to The Future of Privacy Forum's "Pri- vacy Best Practices for Consumer Genetic Testing Services." • Consumer genomic testing pro- viders should refer consumers to appropriate genetic counselors and recommend that they discuss any actionable test results with their physicians. • The additional conditions follow an evaluation of the current landscape of consumer genomic testing by a working group of AMP leaders first convened in 2015. AMP said the working group's evalua- tion resulted in the association support- ing new conditions designed to reflect the range of currently available technologies, highlight privacy best practices, and en- courage consumers to consult with their healthcare providers before making clini- cal care decisions. "We will continue to update our offi- cial consumer genomic testing position as needed to better account for all of the emerging technologies and privacy best practice," Victoria M. Pratt, Ph.D., associate professor, director of pharma- cogenetics and molecular genetics lab- oratories at Indiana University School of Medicine, and president of AMP, said in a statement. "As with any test relevant to a patient's health, we continue to strongly encourage consumers to con- sult with their healthcare providers be- fore making clinical care decisions." n Polygenic Risk Scores Predict Heart Disease Across Diverse Populations A new study confirms that using a poly- genic risk score (PRS) derived from ge- nome-wide association studies (GWAS) for predicting heart disease in people who have never had a heart attack can be used in populations other than the ones used to develop them. Findings like this are critical to the eventual widespread clinical use of PRSs for assigning heart disease risk and im- plementing prevention strategies. In this latest study, researchers tested two previ- ously published PRSs for coronary artery disease (CAD) based on GWAS data from European populations on a different, though ancestrally related, population. "Our results indicate that CAD PRS de- veloped in European-ancestry individuals perform quite well in the genetically and environmentally homogenous French-Ca- nadian population. How well these same PRS would predict CAD in a more diverse European-ancestry population, or in a population living in a very different envi- ronment, remain critical open questions for further investigation," the authors wrote in the paper published in the June 11, 2019 edition of Circulation: Genomic and Precision Medicine, an American Heart Association journal. n Tetiana Lazunova / iStock / Getty Images SCIEPRO / SCIENCE PHOTO LIBRARY / Getty Images

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