Powerful Forces Are Reshaping Lab, Pathology

THERE IS NO BETTER WAY TO UNDERSTAND HOW THINGS ARE CHANGING within the house of laboratory medicine than to survey current news. Understanding why and how breaking news stories are indicators of deeply-rooted and forceful trends is essential for lab administrators and pathologists who want to keep their labs positioned to offer sophisticated and financially-sustainable lab testing services.

One case in point is the exclusive analysis we are publishing in this issue. In this article, we describe a new and powerful dynamic in the field of genetic testing and next-gen sequencing: the interest of big pharma and equity investors in purchasing control of patents and the intellectual property behind the latest diagnostic and gene sequencing technologies.

Why is there such keen interest in controlling laboratory test diagnostics? Interest is high because of the growing importance of companion diagnostics. Pharma companies see that a laboratory test costing $200 to $5,000 can determine whether a patient needs a $50,000 to $500,000 cancer drug, for example. Thus, there is a sound business strategy behind the idea to control companion diagnostic tests used to qualify a specific patient for a specific therapeutic medication.

Another important lab industry trend in the news this month and that we cover in this issue of THE DARK REPORT are comments made by FDA Commissioner Scott Gottlieb, MD. At a lab industry conference, he explained that the lab industry’s unhappiness with the FDA’s earlier plans to regulate laboratory-developed tests caused the administration to reconsider how it should handle that issue.

Of course, another story in this issue will be welcome news to many lab executives and pathologists. Our lead story about Theranos and the charges filed against it by the Securities and Exchange Commission demonstrate that the egregious behavior of this lab testing company and its management is leading to serious consequences.

For readers interested in gaining a more comprehensive understanding of the forces of change in the clinical lab industry and the anatomic pathology profession, our upcoming 23rd annual Executive War College in New Orleans on May 1-2 will feature 60 sessions and 100 speakers on these and other topics.