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CDC to Fund Molecular Genetic Test Pilot for Clinics, Labs

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Centers for Disease Control and Prevention plans to give up to $1.5 million over three years to fund a pilot project to improve and measure the quality of clinical and lab practices for molecular genetic tests in a targeted healthcare delivery system.

The grant, which will provide between $300,000 and $500,000 per year, will fund a project conducted at a fee-for-service network, a health maintenance organization, an academic medical center, or similar entities with a diverse but defined population.

The program will test whether changes in lab practices associated with reporting and the use of molecular test results for heritable conditions and host markers of drug metabolism may be used to improve and ensure the quality of both clinical decision making and patient outcomes.

Earlier CDC efforts in this area include support for work to prepare and integrate molecular genetic lab test results into clinical decision making, and it has addressed molecular genetic testing in primary care settings, where the use of genetics is advancing quickly but where tools for clinical decision making regarding these tests are lacking.

The first model for investigating clinical and lab practices following genetic testing used cystic fibrosis tests, and later tests for assessment of heritable conditions factor V Leiden, fragile X syndrome, Lynch syndrome, warfarin sensitivity, and Ashkenazi Jewish disorders.

The outcomes from those projects supported the need for stronger collaborations between clinical and lab professionals to improve how clinically relevant information is communicated, and how the test findings are integrated into medical decisions, according to CDC.

Those projects also showed “significant variability” in laboratory reporting of genetic test results and poor understanding by healthcare providers of the clinical impact of the findings from genetic tests.

CDC expects that this project will result in good practice recommendations for clinical and lab settings, which may be implemented. The pilot program also may focus on one or more medical conditions that are important within that healthcare delivery system.

The project will be evaluated using performance goals and measures that are similar to those for developing evidence-based clinical and laboratory recommendations, and the process and findings will be shared widely because the these efforts may be of value to other healthcare delivery systems. These other systems may use the knowledge to identify challenges associated with the use of genetic tests and to improve their practices and patient outcomes.

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