Association for Molecular Pathology                       
Newsletter
October 2009, Volume 15, Number 3

Inside this Issue

Front Page
President's Message
Special Features
• AMP Advocacy
• AMP Test Directory
• CHAMP
• JMD Report
• Web Editorial Board
• AMP 2009 Preliminary Program
• AMP 2009 Corporate Workshops

• Announcements
Committee Reports
• Clinical Practice Committee
• Membership & Professional   
  Development Committee
• Nominating Committee
• Professional Relations
  Committee
• Program Committee
• Publications Committee
• Training & Education Committee
Subdivision Reports
• Genetics
• Hematopathology
• Infectious Diseases
• Solid Tumors
2009 AMP Officers and Appointees

Clinical Practice Committee Report

Iris Schrijver, MD

By Iris Schrijver, MD
Chair, Clinical Practice Committee
e-mail: ischrijver@stanfordmed.org

 

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!