Regulatory Issues in Molecular Diagnostics
Molecular
diagnostics, Dallas is referred to as the detection
of genomic variants, aiming to facilitate detection, diagnosis,
subclassification, prognosis, and monitoring response to therapy.
In this chapter, we provide an overview of
the field of Molecular diagnostics, Dallas and of the molecular
diagnostic methods that are described in the
chapters that are included in this textbook.
Regulatory Issues in Molecular
Diagnostics
·
Molecular diagnostics, Dallas grew out of the molecular biology research environment, and as
such, its maturation to a fully standardized clinical laboratory specialty has
been somewhat erratic
·
These are designated Clinical Molecular
Genetics, with certification by the American Board of Medical Genetics
(ABMG), and Molecular Genetic Pathology (MGP), with joint certification by the
ABMG and the American Board of Pathology.
·
The Clinical Molecular Genetics fellowship is 2 years and is
open to anyone with a doctoral degree and graduate training in an area relevant
to genetics; the Molecular Genetic Pathology fellowship is 1 year and is open
only to physicians with primary certification in either pathology or some other
area of medical genetics.
·
The focus of the two fellowships and board examinations are
different, with ABMG concerned mostly with testing for heritable diseases and
MGP spanning the entire spectrum of molecular diagnostics.
·
Unfortunately, this state of affairs still leaves some important
subsets of qualified molecular diagnosticians officially out in the cold, such
as Ph.D. clinical scientists who perform molecular microbiology tests. That
deficit may have undesired effects on employment opportunities and professional
billing.
·
There are also opportunities for technical laboratory staff to
obtain recognition and certification in the Molecular diagnostics, Dallas
field.
·
The American Society of Clinical Pathology now offers a specific
certification in molecular pathology beyond its
general licensure for medical technologists.
·
The National Credentialing Agency for Laboratory Personnel (NCA)
offers a certification examination in clinical molecular biology, open to any
staff with at least 1 year of clinical molecular diagnostic experience.
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