Good Start Genetics®, Inc. developed GeneVu™ and EmbryVu™ and performs the tests in its CLIA-certified and CAP-accredited laboratory. These tests were developed and their performance characteristics determined by Good Start Genetics®. They
have not been cleared or approved by the US Food and Drug Administration. However, the laboratory is regulated under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high-complexity clinical testing and the
tests have been analytically validated in accordance with CLIA standards.