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Home » News

NIH launches online tool providing information about the availability and scientific basis of genetic tests

Article / Review by on February 29, 2012 – 7:33 pmNo Comments

NIH launches online tool providing information about the availability and scientific basis of genetic tests

NIH launches online tool providing information about the availability and scientific basis of genetic tests

To make it easier to navigate the rapidly changing landscape of genetic tests, the National Institutes of Health introduced the Genetic Testing Registry (GTR) today.

The free online tool was developed as a public database to assist health-care professionals to better understand patients’ diseases and researchers to close gaps in scientific knowledge. It also aims to help consumers struggling to decipher the complex world of genetic testing. According to an NIH release:

Genetic tests currently exist for about 2,500 diseases, and the field continues to grow at an astonishing rate. To keep pace, GTR will be updated frequently, using data voluntarily submitted by genetic test providers. Such information will include the purpose of each genetic test and its limitations; the name and location of the test provider; whether it is a clinical or research test; what methods are used; and what is measured. GTR will contain no confidential information about people who receive genetic tests or individual test results.

Genetic tests that the Food and Drug Administration has cleared or approved as safe and effective are identified in the GTR. However, most laboratory developed tests currently do not require FDA premarket review. Genetic test providers will be solely responsible for the content and quality of the data they submit to GTR. NIH will not verify the content, but will require submitters to agree to a code of conduct that stipulates that the information they provide is accurate and updated on an annual basis. If submitters do not adhere to this code, NIH can take action, including requiring submitters to correct any inaccuracies or to remove such information from GTR.

In addition to basic facts, GTR will offer detailed information on analytic validity, which assesses how accurately and reliably the test measures the genetic target; clinical validity, which assesses how consistently and accurately the test detects or predicts the outcome of interest; and information relating to the test’s clinical utility, or how likely the test is to improve patient outcomes.

By Lia Steakley
Stanford University Medical Center

Photo by bettinac

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* Stanford University Medical Center integrates research, medical education and patient care at its three institutions – Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children’s Hospital.

**  The above story is adapted from materials provided by Stanford University School of Medicine

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