Author: Bruce Carlson

“Arbitrary and capricious” is what the College of American Pathologists (CAP) has called the process of deciding to regulate lab-developed tests that the FDA took on earlier this year. This in a strongly-worded amicus brief filed on October 7, 2024. CAP argued that the FDA’s new rule, which classifies LDTs as medical devices, places unreasonable restrictions and significant compliance costs on laboratories. CAP raised concerns that the regulation could delay critical disease diagnoses and negatively impact patient care.CAP President, Dr. Donald Karcher, expressed the growing concern among pathologists, who now face difficult decisions about the availability of LDTs in their…

Clinical laboratories are still dealing with labor shortage issues that other industries have recovered from. Finding trained lab professionals is a much harder process than finding a construction worker or restaurant worker, according to federal statistics. The effects of this shortage are apparent not only to labs but the in vitro diagnostic companies that service them. At the State of the IVD Industry Webinar on September 19th (https://eyeonivd.com/24stateivd-1/), panelists focused on the lab shortage problem and the capacity of automated IVD systems as a solution.”We don’t have enough people at high levels of experience and technical ability in our labs,”…

What is the market opportunity for infectious disease diagnostic tests. How will revenue opportunity for test sales grow next four or five years? In what geographies will the revenues be earned? Who are the company leaders, and what recent trends are experts noticing that market watchers can take note of? These are among the questions addressed at an upcoming webinar you can be part of.A recurring theme in recent Eye on IVD newsletters is the significant potential across various in vitro diagnostic submarkets. Among these, the infectious disease sector stands out as a particularly stable and growing opportunity. Emerging diseases…

Thanks to those who joined our EYE ON IVD State of the IVD Industry Webinar 2024 last week – with participation from Broad Branch Advisors, CAP Today and IVD Logix. US IVD FACES OVERSEAS COMPETITORS: At the 2024 ALDLM conference, analyst Frank Criscione of BroadBranch Advisors highlighted the growing presence of offshore competitors in the in vitro diagnostics (IVD) industry. “One [observation at ALDLM 2024] was that there was a very large presence of offshore competitors,” Criscione said. He noted that while these competitors currently lack FDA clearance, and therefore pose no immediate threat to the market in North America,…

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…