VARIANTYX 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 molecular genetic pathologist is expert in the principles, theory and technologies of molecular biology and molecular genetics. This expertise is used to make or confirm diagnoses of Mendelian genetic disorders, disorders of human development, infectious diseases and malignancies, and to assess the natural history of those disorders. A molecular genetic pathologist provides information about gene structure, function and alteration and applies laboratory techniques for diagnosis, treatment and prognosis for individuals with related 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.

A clinical cytogeneticist demonstrates competence in providing laboratory diagnostic and clinical interpretive services dealing with cellular components, particularly chromosomes, associated with heredity.

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 board certified subspecialty, the molecular genetic pathologist is expert in the principles, theory and technologies of molecular biology and molecular genetics. This expertise is used to make or confirm diagnoses of Mendelian genetic disorders, of human development, infectious diseases and malignancies and to assess the natural history of those disorders. A molecular genetic pathologist provides information about gene structure, function and alteration, and applies laboratory techniques for diagnosis, treatment and prognosis for individuals with related 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.

A masters trained health care provider who collects and interprets genetic family histories; assesses the risk of disease occurrence or recurrence; identifies interventions to manage or ameliorate disease risk; educates about inheritance, testing, management, prevention, ethical issues, resources, and research; and counsels to promote informed choices and adaptation. Certification was established in 1993 by the American Board of Genetic Counseling and prior to that by the American Board of Medical Genetics. Requirements for experience, licensure, and job responsibilities vary among the states.

Source: NUCC, CMS