U.S. flag

An official website of the United States government

GTR Home > Tests > Exome

Performance Characteristics



  • Entire test performed in-house

Analytical Validity


For the MiSeqDx 510(k), three analytical studies were performed. Two were traditional reproducibility/precision studies. The accuracy study, however, was unique in that the data provided included a representative subset of the variants rather than every possible variant.(http://www.illumina.com/company/news-center/feature-articles/what_s-next-for-ngs-regulation-----.html)


Not provided

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help

FDA Regulatory Clearances of the Test

FDA Category Designation
Not Applicable

IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.