Author: Bruce Carlson

EYE ON IVD held its first “State of the IVD Industry 2024” webinar yesterday by introducing key topics like the IVD market opportunity, the ADLM convention, and the implications of the FDA’s final rule on LDTs. Our Bruce Carlson was joined by Frank Criscione (BroadBranch Advisors), Bob McGonnagle (Publisher of CAP Today), and Lawrence Worden (CEO of IVDLogix), all of whom shared their perspectives on the state of the in vitro diagnostics (IVD) industry.Carlson provided an overview of the IVD market, estimating its size between $85 billion and $102 billion. He favored an estimate of $96 billion and predicted growth…

The Association for Diagnostic and Laboratory Medicine (ADLM) conducted a survey of clinical labs and the results are troubling. If the ADLM survey results extrapolate to the whole clinical lab population, six thousand of the twelve thousand U.S. labs developing and performing these tests may just stop doing them.Why does this matter? With all the talk of lab-developed tests, it might be easy to lose sight of their purpose. Most of the time, they are designed to make up for what is not otherwise available. Labs conduct their own tests for rare diseases, such as Huntington’s disease, cystic fibrosis, Gaucher’s…

Recently, there’s been more attention on WNV with reports in Missouri, Wisconsin and other places, and the hospitalization of Anthony Fauci. You hear a lot about this being a mosquito vector (spread) disease, and it is, but birds play a role.The presence of West Nile Virus in the United States is a new one, as infectious diseases go. The first cases arrived in 1999. The New York City metropolitan area was the first to witness the arrival of this disease, which was previously considered tropical in nature. It was thought that perhaps shipping containers had spread the disease. By 2001,…

From layoffs, to preanalytical error reduction in blood gas, to a “hubbed-wheel” lab concept, some in vitro diagnostics (IVD) happenings we’ve noticed recently.CEPHEID LAYOFFS: A PATTERN IN IVD? Danaher subsidiary Cepheid provided notice that it would lay off 626 employees from its Sunnyvale, CA center. This is per a California state worker adjustment (WARN) notice. The firm is consolidating all cartridge manufacturing to its high-tech Lodi plant. Media reports say some employees will go to the firm’s Lodi plant, and there will be some additional hiring, however, there was no statement that the Lodi hires and moves would total the…

It’s been our honor to cover our first ADLM meeting as EYE ON IVD Newsletter. We thank the ADLM Press Office for coordinating with us, and vendors for providing us with new developments. Look out for our WHITE PAPER “What You May Have Missed at ADLM 2024” Coming Soon.On Thursday, the ADLM (formerly AACC) announced that 18,000 laboratory medicine professionals had registered for the Chicago meeting, with the number sure to go up with today’s walk-ins. The association reports a 6% increase in attendance since the last time ADLM was in Chicago in 2022.COMPANIES WANT TO SELL TO LABS: Here’s…

Consider the children. This was the theme of a live-streamed event last night hosted by ADLM in Chicago, along with the American Medical Association and the Children’s Hospital Association. The three associations made the case yesterday that the FDA’s new rule regarding laboratory-developed tests would cause harm to healthcare, particularly in the realm of newborn screening and childhood disease.They discussed how the FDA’s new rule will impede healthcare professionals’ ability to provide quality patient care. Attendees of this session will also hear from a caregiver and patient advocate on the importance of laboratory-developed tests in diagnosing medical conditions. The session…

BURNOUT: One in five lab professionals report being burnt out. That’s the finding from a study of 400 lab professionals commissioned by Siemens Healthineers and conducted by The Harris Group. Other findings of the survey:- 28 percent of those over 50 want to retire next 3 to 5 years.- 39% are dealing with limited staff- 27% dealing with lab shortages- 14 percent admitted they made high risk errors due to burnout.- Academic and Research have higher satisfaction. Public labs have high workloads. Private labs have the highest burnout.None of these challenges are easy. Siemens, as a top 10 IVD company…

Inspecting the first quarter of 2024 in vitro diagnostic results, we may be getting to growth without the “ifs, ands, or buts.” Four years out from the pandemic, that is a reasonable goal.What do we mean by that? IVD test markets – markets for chemistries, critical care, infectious disease tests, cancer tests, have always been growing, even through the pandemic. This is a time of aging populations and healthcare expansion around the world. COVID-19 revenues were seen in such large numbers that they then depressed revenue growth later. So companies adjusted, offering explained results. “core revenues are up” etc. But…

When you hear a market figure (even from me) such as “the IVD market is $97 billion” it must be considered in all its dimensions. For one, many different individuals are receiving that revenue in some form, even if the lion’s share of it will be claimed by a few well-known names like Siemens or Revvity. There are landlords, there are employees (you could break out those by executives, salespeople and employees), there are shipping agents, there are distributors. Lately, retail outlets have been taking a share of home testing markets. But put these entities aside for a moment. They…

Whether or not the nation would be ready for a theoretical bird flu pandemic, it’s worthwhile to look at how the testing industry might perform. I should be clear that as I write this, there a just a few human cases in the United States. I’m not even sure a next pandemic comes from another respiratory threat (compared to mosquitoes, say). But let’s assess the possibility. The in vitro diagnostics, or clinical test, industry was the front line in responding to the COVID-19 pandemic. They would be the front line for any pandemic where treatments or vaccines are not employed…