IGENOME, INC.

(1) A clinical laboratory is a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered clinical laboratories. (2) Any facility that examines materials from the human body for purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of, the health of human beings. Typical divisions of a clinical laboratory include hematology, cytology, bacteriology, histology, biochemistry, medical toxicology, and serology.

A clinical biochemical geneticist demonstrates competence in performing and interpreting biochemical analyses relevant to the diagnosis and management of human genetic diseases and is a consultant regarding laboratory diagnosis of a broad range of inherited disorders.

A clinical molecular geneticist demonstrates competence in performing and interpreting molecular analyses relevant to the diagnosis and management of human genetic diseases and is a consultant regarding laboratory diagnosis of a broad range of inherited disorders.

A clinical geneticist demonstrates competence in providing comprehensive diagnostic, management and counseling services for genetic disorders.

A medical geneticist works in association with a medical specialist, is affiliated with a clinical genetics program and serves as a consultant to medical and dental specialists.

Source: NUCC, CMS