ONCE AGAIN, THE LATEST NEWS OF IMPORTANCE in the clinical laboratory industry includes disparate topics that include legal/regulatory, new technology in anatomic pathology, fraud involving lab testing, and more consolidation in the in vitro diagnostics (IVD) industry.
You will find coverage on all of these topics and more in this issue of The Dark Report. Each intelligence briefing presented here contains actionable insights you can use to position your laboratory for success. However, one thing, in particular, stands out. The developments in recent weeks perfectly illustrate how the market is stratifying the winners and losers in diagnostics and lab testing.
For example, the “haves” are strengthening their financial position and market share. This is affirmed by the fourth quarter and full-year 2020 earnings reports of the major IVD manufacturers that are covered here. In specific ways, these clinical lab suppliers have prospered during the COVID- 19 pandemic, as demand for analyzers, automation, and collection kits for molecular SARS-CoV-2 testing soared. Added to this is the substantial funding directed to these companies by the federal government and many states.
The “have nots” are clinical labs throughout the country that were at the end of the supply chain when the pandemic arrived last March. They continually struggle to acquire the instruments, kits, and collection supplies they need to provide COVID-19 testing to their communities. Consequently, they also lost the cash flow and revenue that would come from performing these vital tests.
Next are the bad actors in the clinical lab industry. You’ll read here about the resolution of two separate federal fraud cases involving lab testing. In one case, the defendants will pay restitution totaling millions of dollars. In the other case, four owners and managers from one lab pled guilty to criminal charges and the medical director of the lab will soon go to trial in his case. Unfortunately, these fraud and abuse cases taint all labs in the eyes of the Department of Justice, Centers for Medicare and Medicaid Services, and Congress.
Collectively, the news and analysis presented in this issue remind lab leaders that the clinical laboratory marketplace continues to change in a dynamic way. It is a reminder that all labs should be nimble and innovative to sustain clinical excellence and financial stability.