Author: Bruce Carlson
“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…
No better place to be when the FDA announces a final rule on lab testing than at the Executive War College ( #EWC2024 ) in New Orleans. It’s a meeting that gets down to business, because it is about the business of laboratories. Over 1,000 attendees, and the majority of them manage labs. Great place to talk, eat gumbo and beignets, and find out what’s happening on the ground.This year was no exception. Some key points from the meeting:A “Trifecta” for Labs, and not a good one!Payment pressure and new CLIA & LDT regulations formed a trifecta for the lab…
Nothing like a billion new people to help grow a market. That’s the case of infectious disease in vitro diagnostic testing, in the period that our upcoming report covers. Of all the reasons the markets will grow – new threats, improved tech, increased usage, a key reason the market will grow is new people.947,900 million of them to be exact, primarily residing in what we term as “developing nations,” contrasting the advanced economies with established healthcare systems. These newcomers will call places like Indonesia, Senegal, India, Peru, Mexico, and Romania their home. Over this period, the population of the developing…