Author: Bruce Carlson

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…

“You’ve been speeding all along, we just haven’t chosen to pull you over yet.” that is my paraphrase of the framing of FDA enforcement of lab-developed tests under the rule announced April 2024. This was a point emphasized at the recent ADLM webinar on the new LDT rule, essentially: labs conducting lab-developed tests have been in violation since 1976. This was one of the many points hammered home by an informative webinar conducted by the largest association of laboratorians and the suppliers who support them, the ADLM (formerly AACC).The webinar is available here: https://www.youtube.com/watch?v=X1Go-G5Gdrs Highly suggest a watch. I cannot…

Improper thyroid function is important to detect, as it can lead to issues with heart rate, mood, energy level, metabolism, bone health, pregnancy and many other functions. The most common way to to test thyroid function is to find levels of the hormone regulated by the pituitary gland, TSH (thyroid-stimulating hormone).TSH tests are useful. Thyroid hormones exert influence over almost every organ, including the heart, governing weight, body temperature, muscle vigor, and emotional state. Insufficient levels of thyroid hormones in the bloodstream can slow body functions and the reverse is true as well. TSH is a blood test, is common…

Panel tests catch the culprit, so to speak. In a situation where there could be many diseases causing symptoms, these tests find out which one. The more important it is to know, the more compelling the use case for the panel. A recent examination of EMRs of 11,000 Veterans Affairs patients highlights that COVID-19 is more dangerous than flu for hospitalized patients. Thus knowing which of the two diseases the patient has is important.The study, conducted as it was in this most recent flu season, confirms this higher danger is true even in the post-pandemic era, though some talk was…