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Clinical
Practice Committee Report
With
the fruit trees blossoming and daffodils lining the freeways
it is clear that Spring is in full swing, and so is the
Clinical Practice Committee (CPC). We have monthly phone
conferences and a myriad of initiatives and projects on
which individual members work in between our calls. If you
have not seen it yet, I encourage you to check out the
Catalogue of Mutation Database Websites on the AMP website,
which can be viewed in the “Clinical Practice Committee
Comments and Projects” section of the CPC webpage
(http://www.amp.org/CP/clinicalpractice.htm).
One can navigate there, from
www.amp.org > About AMP > Committees >
Clinical Practice.
The
CPC has also commented on ACMG guidelines on myotonic
dystrophy; provided input on the long-range-planning white
papers from the National Human Genome Research Institute (NHGRI);
and created a position statement on the recommendations from
the American Society of Human Genetics (ASHG) on commercial
and academic ancestry testing efforts. In February, the AMP
Council decided that the “AMPRCP”, a working group with
members from the Public Relations Committee, the Economic
Affairs Committee, and the Clinical Practice Committee, will
draft a response to the Genentech Citizen Petition to FDA
regarding lab-developed assays.
A
working group that includes Genetics Subdivision
Representatives Murali Muralidharan, and
Narasimhan Nagan, and Hematopathology Subdivision
Representative Dan Sabath is investigating the design
of a “road map” on how AMP could proceed when payers pose
questions about test utility and reimbursement. The working
group is currently determining the scope of the project and
the steps that should be followed when a request is received
from third party payers. Hematopathology Subdivision
Representative Joe Pulliam is working on a control
material project for NPM1 and other cell lines for
hematopathology assays.
In a
project originally started by Jan Nowak, Solid Tumor
Subdivision Representative Bill Funkhouser is
completing the creation of a manuscript on Microsatellite
Instability (MSI) testing in colon cancer. Solid Tumor
Subdivision Representative Federico Monzon is
exploring a new project concerning a database of validated
microsatellite markers for loss of heterozygosity
as well
as a KRAS
sample exchange.
Infectious Diseases Subdivision Representative Donna Wolk
is focusing on quantitative reference materials for BK
virus, whereas Belinda Yen-Lieberman is working on a
project involving quantitative reference materials for CMV.
Ad hoc
member Ira Lubin leads a project on the reporting of
genetic test results. The journal, Genetics in Medicine,
invited the working group to submit a commentary discussing
the broader ramifications of the initial findings. This
commentary will be authored by those who have been directly
involved in past work, including Jean Amos Wilson,
Elaine Lyon, and Vicky Pratt who have also been
past members and Chairs of the CPC. The current CPC will
provide input.
Michelle Dolan,
one of
our ad hoc members, is leading a project on
the analytical evaluation of genotyping assays. Together
with ad hoc members Fernanda Sabato and
Patrik Vitazka, she is developing a practical
guideline/checklist to which laboratories can refer.
And
last but not least, Mary Williams is bravely fielding
all our questions, capably helping to juggle all our
projects, and taking terrific minutes. Our next project
shall have to be an attempt to clone her. Thanks, Mary!
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