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Clinical
Practice Committee Report
Hello
AMP members!
I hope
you all had a chance to enjoy the Summer. In the Clinical
Practice Committee (CPC), everyone has been busier than ever
and we have concluded that the often mentioned “summer-lull”
simply does not seem to exist anymore!
Let me
fill you in on some highlights …there have been many
activities within the CPC, but most are still ongoing and
will be reported in a future Newsletter.
In
April, the manuscript from last year’s CPC Methylation
Working Group was accepted for publication in the July issue
of the Journal of Molecular Diagnostics (JMD): “CpG
Methylation Analysis - Current Status of Clinical Assays and
Potential Applications in Molecular Diagnostics: A Report of
the Association for Molecular Pathology.”
The
CPC, with welcome input from others, has also crafted an AMP
document to United States House Representative Gordon
regarding the urgent need for certified reference materials,
which are critical to continued innovation in healthcare and
for the realization of personalized medicine. We pointed out
that molecular genetic assays provide the cutting edge for
many individualized therapies in oncology, transplantation,
infectious disease and genetics, but the production of
certified reference materials has fallen far behind the
technical capabilities of these assays. The best approach to
achieve consistent and comparable quantitative data amongst
laboratories is by the use of internationally established
reference reagents, and the goal of the CPC is to increase
the speed with which the National Institute for Standards
and Technology (NIST) can prepare quantitative standards.
This is critical to the national and international
laboratory community and their ability to deliver accurate
test results. The
deliverable will be purchasable standardized reference
materials that would ideally be available for
inter-laboratory comparison studies and purchase by
commercial and clinical laboratory communities.
In
response to concerns from AMP members, the CPC sent a letter
to the New York State Department of Health to draw attention
to the pressing issue of delays in the review of validation
packages for approval of molecular tests, which are listed
to receive initial review in a time frame of no longer than
45 days. The letter was not intended to criticize the work
of the reviewers, who surely must be overwhelmed with the
growth in the number of submissions, rather, the aim was to
advocate for our members to achieve a better, efficient, and
transparent process so that residents of NY State can have
timely access to the testing that their health care
providers prescribe. We recently received a response from
the New York State Department of Health and were informed
that internal changes to the review process have been made
in order to accommodate the recent increase in workload and
complexity. Furthermore, the backlogged and current pending
reviews will be completed within the 45 day review time
frame to meet AMP members’ needs. I invite you to comment on
your experience with the newly implemented process by
sending me an email with your feedback.
The
CPC has communicated with the FDA on the matter of brand
name diagnostics on drug labels. In this letter, which is
available for review on the AMP website, AMP advocates for
an FDA practice of identifying a companion diagnostic on
drug labeling by the biological description rather than by
market brand name. AMP thinks that it is very important that
FDA not endorse one approved/cleared diagnostic product over
another. In the letter, AMP commends the FDA and the Center
for Drug Evaluation and Research for establishing this
significant precedent of referencing to the biological
description of a diagnostic test in the labeling of a
companion therapeutic. This ensures that laboratory
directors are able to use their clinical judgment to select
the most appropriate test method.
Finally, on the AMP website, the AMP Web Library now
offers a document for our members crafted by the CPC, with a
practical approach to assay validation, definitions,
guidelines and helpful references. We hope you find it
useful.
I hope
to see you all in November at the AMP Meeting in Kissimmee,
FL! |
