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 Sunnyvale exits. (Those facts suggest to EYE ON IVD that some movement towards automation is involved.)
Any news about layoffs must be put in perspective, of course. It rarely makes news when companies are hiring, after all.
News about layoffs must be put in perspective. There are rarely news stories about thousands of hires in an industry.
The Cepheid news could be part of a pattern. Per MedTechDive, Medtech firms have cut more than 14,000 jobs in the past 18 months and the largest industry laying off is – wait for it – diagnostics! There have been more than 5,000 affected positions, according to MedTech Dive’s analysis. (MedTech Dive’s round up is here: https://www.medtechdive.com/news/medical-device-layoffs-tracker/720928.) The firm compared these layoffs to 865 in labs and just 210 in imaging. While the firm said the peak of the layoffs were in Q2 2023, they are not exclusive to that quarter.
A POC BLOOD GAS SYSTEM THAT DETECTS HEMOLYSIS? Hemolysis is the enemy of blood gas testing, particularly point-of-care testing for critical potassium tests. The breaking down of red blood cells in a sample changes blood composition and potentially interferes with the accuracy of test results.
For instance, a study conducted at an Oregon hospital (https://doi.org/10.1515/cclm-2024-0351) tracked the use of a standard POC blood gas system. They retested the results from the POC analyzer on lab-based clinical analyzers, within 90 minutes. The study found that 40% of patients with high potassium results, didn’t actually have high potassium in their body. It was just in their sample. 12% of the patients needed either a redraw or a new treatment scheme. (Read: $ spent) That’s just one study, others show contaminated blood samples at higher or lower levels.
ER and ICU doctors are not unaware of this problem when they use POC tests. But, to date, there hasn’t been a great solution for both obtaining results quickly for acute setting speed and assuring error-free accuracy.
At ADLM in Chicago, Werfen unveiled their solution. The Barcelona-based company’s GEM Premier 7000 with iQM3 system (https://www.werfen.com/na/en/point-care-testing-devices/gem-premier-7000-iqm3-whole-blood-hemolysis-detection) detects hemolysis while delivering a comprehensive menu of blood gas results, including pH, pO2, pCO2, sodium, potassium, ionized calcium, chloride, glucose, lactate, hematocrit, total hemoglobin, total bilirubin, and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) in just 45 seconds. It not only performs these tests but also checks for sample issues. The quality management system within the GEM Premier 7000 monitors for hemolysis and other errors, such as air bubbles, that can interfere with results.
40% of patients that had high potassium in their sample, didn’t actually have high potassium in their body.
CHINA IVD MEETING HELD: No letdown in interest in China among in vitro diagnostic makers. Following ADLM in the United States, there was a smaller but well-attended in vitro diagnostics meeting in China. IVDCHINA drew 50 exhibiting companies, had thousands of attendees, 130 speakers and 70 keynotes. The event was held in Zhangjiang, Shanghai.
Executives from BGI, Takeda, Illumina, Amoy Diagnostics, Roche, Quanterix, Sansure Biotech, Autobio, Berry Diagnostics and others participated in the events.
China’s IVD market ranges in estimates from $6 to 10 billion, not inclusive of glucose tests.
LAB AND VENDOR VIEWPOINTS – Good discussion in CAP TODAY with IVD vendors and laboratories participating and where things are headed. Worth a read: https://www.captodayonline.com/lab-vendor-views-on-instruments-assays-and-data/
We found the following comments of particular interest:
- Roche: Ryan Stephens, group marketing manager, automation and core lab digital solutions, Roche – noted that “health systems are getting bigger [and]…large reference labs are buying up and partnering with health systems.” Not surprisingly Roche is targeting these twin agents of consolidation with their solutions.
- Emory U: David Alter, MD, director of clinical chemistry, Department of Pathology said “My ask of in vitro diagnostic companies is to recognize that if labs or hospital systems adopt what I call a ‘hubbed wheel.’ We need testing done on the periphery using smaller versions of the primary instruments so we don’t duplicate our resources.”
- Siemens: Martu Richards at Siemens said the company was hearing from smaller customers that they needed total lab automation. The vendor did not think that was the case in the customers requesting. Thus Siemens is offering advanced sample management features, typically found in large laboratories with automated systems, to smaller hub-and-spoke laboratories using the comany’s Atellica CI system.
WASTEWATER SHOWS COVID INCREASE? The CDC has reported a concerning increase in COVID-19 levels across the United States, with wastewater surveillance revealing “very high” levels in at least seven states, including Virginia and North Carolina. This method of testing has proven valuable in detecting infectious diseases within communities, often identifying the virus before symptoms emerge. Additionally, the CDC has released a report focused on preventing and controlling infectious diseases in colleges. For companies in the in vitro diagnostics field, these developments may signal an increased demand for diagnostic testing products and services. As COVID-19 levels rise, there could be a heightened need for rapid and accurate testing solutions to monitor and manage the spread of the virus. This scenario presents both challenges and opportunities for these companies, as they may need to scale up production, innovate new testing methods, and collaborate with public health agencies to address the evolving needs of the pandemic response.
Spread the word about EYE ON IVD to interested friends in IVD.
Look out for our webinar!! Scheduled tentatively for SEPTEMBER 19th – More Information to come!!!
