Don't forget clinical laboratories
In “Biomarkers: from research to utility” (July 2011), the author eloquently emphasizes the importance, today and in the future, of biomarkers in realizing the potential that molecular medicine has for creating more targeted (“personalized”) diagnostics and therapeutics. He draws attention to the significant hurdles that diagnostics companies face in funding clinical trials currently necessary for regulatory validation. He also emphasizes the importance of a strong partnership between diagnostics companies and pharma necessary to create companion diagnostics. He fails, however, to emphasize the critical role that clinical laboratories play in actually delivering the biomarker tests to patients and their physicians. Without CLIA-certified clinical laboratories these disease-altering diagnostic and management tests would not be fully accessible by patients. Furthermore, CLIA-certified laboratories play a critical and necessary role in expediting the availability of well-validated laboratory-developed tests in this molecular medicine domain. The regulatory pathway for clinical laboratories to bring LDTs to practice is particularly important for biomarkers aimed at rare or otherwise infrequently encountered diseases where diagnostics companies often find little incentive to develop. The partnerships necessary to pave the pathway to “personalized” medicine's great potential must include diagnostics companies, pharma, regulatory agencies and CLIA-certified clinical laboratories.
Thank you.
—Ronald L. Weiss, MD, MBA
Professor of Pathology
Department of Pathology ARUP Laboratories
Director of Faculty Outreach
Technology Ventures Development
University of Utah
Editor's note: Thanks to Dr. Weiss for pointing out that clinical laboratories are indeed a critical part of the process and the partnership.
What IS in a name?
Regarding “A lab by any other name?” (Letters column, June 2011): If Deven really wants a new name for the Lab, how about “diagnostic testing” or “biomedical testing” or “biomedical diagnostic testing”?
—Edward Choe, MT(ASCP)
Kaiser Permanente
Cascade Park Medical Office
Vancouver, WA
Editor's note: For those readers who do not have the June 2011 issue at hand, Ed Choe is referring to a letter from reader Deven McDougall which asked for a “more scientific name” for the hospital laboratory. Deven wrote: “Just about every department in our hospital has a very professional sounding name, but we are still “the laboratory….” Ed's suggestions are well-taken; do readers have any other ideas?
Someone your should know
Editor's note: I was pleased to tell the story of one med tech I know whose work ethic is typical of that of his profession (December 2011, “From the Editor,”). I was also very pleased to receive the following feedback from two readers—one of whom happened to have trained the tech I profiled!
Enjoyed your editorial. I knew Eric. I helped train him in blood banking when he first came to Hinsdale. I haven't seen him in a long time because I moved off campus, and I never knew he played the organ!
Thanks for your encouraging words to techs everywhere. I thought that you were “spot on.”
—Sharon Kuta
DuPage Coagulation Center
Clarendon Hills, IL
Such a nice article. We need more of that kind of recognition, not just for working holidays, but from time to time to boost morale.
—Jo Ann Potts, BS MT(ASCP)
Quality Improvement Coordinator
Rush University Medical Center
Chicago, IL
A reader's correction
In an article in the March 2012 issue of MLO, titled “Analytical challenges for forensic screening of drugs of abuse,” there appears to be an outdated statistic on page 10. The article states that TCAs remain the most common cause of death from prescription drugs and references two articles from 1992 and 1994. I would suggest that you find more current statistics on prescription drug deaths. Prescription pain medications have exceeded drug deaths for numerous years and are still on the rise.
I refer readers to a more recent source from the CDC: Policy Impact: Prescription Painkiller Overdoses. There are also many others from individual states that track drug deaths from Medical Examiner offices. As a matter of fact, our lab does postmortem toxicology testing and we see very few drug deaths from TCAs as compared to opioids.
Thank you for your attention to this matter and thank you for your -publication.
—Linda Sullivan
Supervisor Toxicology/Forensic Services
Wuesthoff Reference Laboratory
Melbourne, FL
Editor's note: We thank Ms. Sullivan for pointing out to us and our readers that our writer was using an outdated source and thus made an inaccurate assertion in the March drugs-of-abuse story. We try to get it right—but when we don't, we rely on readers to help us get it right the second time.
MLO welcomes letters to the editor. We ask that you include a phone number for verification. While we prefer to publish the writer's name, we will publish a letter with “name withheld by request,” but our editorial staff must have the writer's name confirmed for our files. MLO reserves the right to edit any letter for style and length.
