Here we go again. A big headline about a laboratory developed test (LDT) that was giving out wrong results to lots and lots of people. This was was about Vitamin D testing by Quest. This article also highlights the problem of having non-standard tests at each institution.
There have been others that have made the news. For example there was the whooping cough debacle of 2007. There have several scientific papers written on the variability of Her-2/neu testing within and between labs. And lets not forget the recent issue of LabCorp releasing the OvaSure test without proper validation.
I'm a believer in the personalized medicine dream. I really want, when it's my turn to get sick, have diagnostics that will help my doctor pick a drug or assign a treatment that will truly help me. I'd also like to know when I'm really not going to benefit from a treatment that could be worse than my disease.
New innovations will be slowed by a lack of confidence in even the most simple tests, like Vitamin D. How can we trust the fancy new molecular test for a particular drug if we can't even get the basics right? These type of headlines also force our regulatory agencies to go into overdrive. Whether it's FDA job to come in and save the day; or more money and expanded regulatory authority needs to go to CMS ... changes will be made.
As a community we have all got to strive to be better. The regulatory agencies have to get together and decide whose job it is to regulate LDTs and let us know what the standards are. Labs have to do more than the bare minimum before putting a test on the market.
If we don't pull together here, the regulatory agencies will have to step in. We've got to do a better job of holding ourselves to extremely high standards... if we don't, someone else will.
Tags: Best Practices, IVD
