| Recommendations of Scientific
Societies and Taskforces American scientific and
medical societies issue policy statements which address concerns within the organizations.
Often the statements include blanket recommendations that may positively or negatively
affect the proliferation of molecular diagnostic procedures.
For example, in November of 1989, soon after the discovery
of the gene for cystic fibrosis, the American Society of Human Genetics issued a statement
recommending genetic testing for individuals with a family history of CF. However, in that
same statement, the ASHG considered screening of the general population to be premature,
citing inadequacies in the accuracy of the test and calling for establishment of
centralized quality control for testing laboratories.
Three years later, the Society released a second statement,
still recommending against screening of the populace. However, in May of 1997, the
National Institutes of Health issued a policy statement recommending that CF carrier
testing be offered to all pregnant women. As a result, CF screening could become the
standard, with physicians that fail to offer the test to a pregnant woman legally liable
if the mother gives birth to an affected child.
The ramifications of such policy statements are enormous.
If testing for CF and other inherited diseases becomes the standard for all pregnancies, a
significant increase on expenditures on the appropriate molecular biology reagents would
be realized. Most scientific societies maintain a presence on the worldwide web and issue
public releases of policy statements. Careful monitoring of societal recommendations can
enable reagent manufacturers to effectively react to important changes in the molecular
diagnostic marketplace.
Government Regulation of Homebrew Procedures
Molecular diagnostic tests can be divided into two
categories:
- Tests offered as a service by a licensed diagnostic
laboratory that incorporate research products and homemade reagents into diagnostic
protocols.
- Diagnostic kits that have been approved by the Food and Drug
Administration (FDA) for diagnostic applications.
|
