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Clinical
Practice Committee Report
At our
face-to-face Clinical Practice Committee (CPC) meeting at
the AMP Annual Meeting in Florida, we welcomed several new
members: Jeffrey Wisotzkey as the incoming Infectious
Diseases representative, Christine Curtis as our
incoming representative for the Genetics Subdivision,
Jane Gibson for the Hematopathology Subdivision, and
Neal Lindeman, who is the incoming representative for
the Solid Tumors Subdivision. We also said a fond farewell
to Committee members who rotated off. I thank the outgoing
Committee members Belinda Yen-Lieberman (Infectious
Diseases), Bill Funkhouser (Solid Tumors), Dan
Sabath (Hematopathology), and Kasinathan Muralidharan
(Genetics) for their enthusiastic service on the CPC. We
are still working with all on a variety of 2009 projects and
are fortunate that Belinda and Bill will continue their
affiliation with the CPC in 2010.
2010
promises to become another interesting year for this
Committee. Stay tuned for project updates!
The
following is a compilation of the wide range of activities
the CPC has been involved in 2009.
Clinical Practice Guidelines and Comments
CPC
drafted a letter to the World Health Organization supporting
the UK NIBSC (National Institute for Biological Standards
and Control) for development of certified reference
materials for the World Health Organization. ESHG and CDC
also sent letters.
Status: completed (December 2008)
AMP
formed an ad hoc hybrid committee with members from
the Professional Relations Committee (PRC) and CPC (“AMPRCP”)
to jointly address the Genentech petition to the FDA to
regulate Lab Developed tests (LDTs). The AMP response was
sent to the FDA.
Status: completed (January 2009)
CPC
responded to the published ACMG guidelines on myotonic
dystrophy.
Status: completed (January 2009)
CPC
responded to a request for public comment by the National
Human Genome Research Institute’s (NHGRI) on their phase I
white papers in the context of NHGRI’s long-range planning
project.
Status: completed (February 2009)
CPC
responded to the recommendations from The American Society
of Human Genetics (ASHG) on commercial and academic ancestry
testing efforts. CPC created an AMP position statement and
it was sent to ASHG.
Status: completed (March 2009)
CPC
provided input to the House Science and Technology Committee
(to Rep. Gordon) regarding the need for and priorities in
the development of NIST reference materials
Status: completed (June 2009)
CPC
created a letter to the NY Department of Health regarding
the delays in reviews of molecular genetic and virology test
requests to NYS. AMP received a response from the NYDOH re:
long review times in August, which was posted on CHAMP.
Status: completed (June 2009)
CPC
created a letter to the FDA to commend FDA for the important
precedent of labeling of ImClone and Amgen drugs which
specifies KRAS mutation analysis but does not specify a test
by brand name. AMP encourages FDA to always identify a
companion diagnostic on drug labeling by the biological
description.
Status: completed (August 2009)
CPC
and PRC jointly commented on the draft report from the
Agency for Healthcare Research and Quality (AHRQ): “AHRQ
Draft Report on Quality, Regulation and Clinical Utility of
Laboratory developed Tests”.
Status: completed (September 2009)
Publications/Presentations
The
Catalogue of Mutation Database Websites went live in the CPC
section on the AMP website. Five new websites have been
added in 2009.
Status: Completed (November 2008)
The
CPC Methylation Working Group manuscript was accepted for
publication in the July issue of JMD: “CpG Methylation
Analysis - Current Status of Clinical Assays and Potential
Applications in Molecular Diagnostics: A Report of the
Association for Molecular Pathology”.
Status: completed (April 2009, published in JMD in
July 2009)
CPC
created a comprehensive table of AMP publications on
practice guidelines/guidances, to be posted on the AMP web
site.
Status: virtually completed (October 2009)
Analytical evaluation of genotyping assays – an AMP
guideline for our membership, available on the website
(members-only). The guideline is a brief practical reference
to be used during the validation process. Additionally, a
sample summary validation checklist is provided as a
template.
Status: completed (October 2009)
Projects
Genetics (Kasinathan
Muralidharan
and Narasimhan Nagan)
New SMA testing guidelines were published by American
College of Medical Genetics. CPC will be commenting.
Status: Active
MCC/prenatal
practice guidelines manuscript. An outline draft has been
finished and a full draft of the manuscript is in progress.
Status: Active
Hematopathology (Dan Sabath and
Joseph
Pulliam)
CPC is exploring a JAK2 sample exchange to address issues in
“Sample prep Techniques Qualitative/Quantitative”.
Status: Active
Control material project for NPM1. There currently is only
one available cell line (for Mutation A). CPC has not
received any information regarding reference materials from
our CHAMP request or literature searches. This might be a
project for GeT-RM, i.e., search for cell lines. Synthetic
controls for a quantitative assay would need to be created
by NIST.
Status: Active
Infectious Diseases (Belinda
Yen-Lieberman
and Donna Wolk)
AMP is developing guidelines for ID panel grouping, with
appropriate infectious disease organizations.
Donna
is the EAC liaison (panels and associated coding
needs).
Belinda is leading the RPWG
(Respiratory Pathogen Working
Group). The priority is assessment of utility and
billing codes for influenza testing. The second priority
will be assessment of utility of viruses in the respiratory
panels via literature review (planned for publication in
JMD).
Status: Active
CPC is
represented in the TB project of
C-Path and USDS (US Diagnostics Standards), to
accelerate TB drug available for MDR and XDR.
Background:
The Critical Path Institute in Tucson works with FDA to
speed drug, and now diagnostic, assay development. The focus
for USDS is any companion diagnostics associated with a new
drug that will be planned for FDA submission and for which
there will be a companion laboratory assay.
CPC
will invite participants to this project via CHAMP.
Status: Active
Quantitative reference materials are needed for CMV and BK
virus. CPC is working with NIST. Nothing currently in
existence is satisfactory, lending even greater urgency to
the NIST project. CPC (AMP) is lobbying for the needs for
these reference materials.
Status: Active
Solid
Tumors (Bill Funkhouser and
Federico Monzon)
MSI
testing manuscripts: A 1st paper will include a
broader range of mismatch repair defects beyond Lynch
Syndrome. A 2nd paper will explore the detection
of Lynch Syndrome patients by screening of extra-colonic
tumors. A “Publication Plan” form is being completed.
Status: Active
Practice guidelines for tissue fixation. A manuscript is in
preparation regarding the effects of ischemia and fixation
on DNA, mRNA, and microRNA.
Status: Active
Creation of a database of validated microsatellite markers
for LOH. CPC sent out a message on CHAMP with an excel table
to be filled out by the membership.
Status: Active
Testing recommendations for KRAS manuscript. A
“Publication Plan” form is being completed.
Status: Active
Synoptic Reporting
Ad hoc
member Ira Lubin leads a project on the reporting of
genetic test results. 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 a group of 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.
Status: Active
Clinical Utility Project
A CPC
working group has proposed a “road map” on how AMP could
proceed when payers pose questions about test utility and
reimbursement. The working group outlined the steps that
should be followed when a request is received from third
party payers. Other AMP committees are reviewing.
Status: Active
Creation of a Nomenclature Database (with standard
nomenclature and the common names)
To be posted on the AMP website (members only)
Status: Active
Recommendations
We
encourage all AMP members to alert Council or appropriate
Committee members when laboratory guidelines or
recommendations are opened for public comment.
We encourage AMP members to actively contribute to calls for
information from the CPC. |
