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,” said Bob McDonnagle, Publisher of CAP Today. They’re retiring left and right. We’re we’re facing an enormous shortfall of that sort of talent.
From an IVD perspective, McDonnagle added: “[the staffing problem] is worth bearing in mind for anybody who’s contemplating any kind of adventure in diagnostics and laboratories right now.”
To echo the point made by McDonnagle: Vacancy rates in laboratories are estimated to be 7–11%, and as high as 25% in some geographies. A Siemens Healthineers survey released at the ADLM conference showed that labs thought “limited staff to support laboratory operations” was their greatest challenge. Five percent of laboratory professionals reported that their lab had closed temporarily because of understaffing. (https://www.siemens-healthineers.com/en-us/press-room/press-releases/harris-poll-clinical-labs)
If this extrapolates to the general population of labs, it would be higher than employee shortages in restaurants (6.4%) or construction (5%). https://www.restaurantbusinessonline.com/operations/restaurants-labor-situation-has-improved-its-far-perfect.
The rate of job openings for hotels and restaurants has fallen from 9.6% in November 2022 to 6.4% in November of 2023. That is a substantial improvement. Yet it remains higher than almost any other industry, except health care and social assistance jobs. The same article notes that 5% in construction.
McDonnagle also said that qualified labor shortages extend to the vendor side:
“Even in the industry. I’ve found the IVD industry now has a real labor shortage, and they’ve been reluctant to find people to bring in. I’ve never seen so the departments that are so sparse in their in their complement of personnel.”
Said Lawrence Worden of IVD Logix: “Centralization of testing and, reimbursement, lack of, of shortage of personnel as well. That’s why we’re seeing LabCorp and Quest keep eating up outpatient testing businesses and other competitors.”
Frank Criscione pointed out on the webinar how lab staff shortages go right to the future of promising technology.
“I’m a big proponent of mass spec. I think that it is going to be the future of diagnostics.” said Frank Criscione of BroadBranch Advisors (broadbranchadvisors.com). However, he said: “It will work if you have the trained technicians to run that sort of instrumentation, automation is going to be key… Is it going to be to integrate that into already existing labs with the talent that is currently there?
Roche Puts Temperature-Activated Test Technology to Work in Europe
Without changing PCR itself, Roche’s in-house scientists figured out a way to get more capacity, and accuracy, out of the technology they’ve owned for decades. That’s now been used in a real-world product approved in Europe. Roche scientists added precision temperature to the signaling of PCR. It’s new Cobas Respiratory Flex test, can multiplex screen for 12 respiratory viruses, allowing the detection of multiple pathogens with a single test.
Temperature-Activated Generation of Signal (TAGS) technology is an advanced diagnostic method that enhances pathogen detection by integrating temperature-based activation with signal generation. In this system, specific chemical reactions are triggered at precise temperatures, which helps control when signal generation occurs. Combined with Polymerase Chain Reaction (PCR) technology, TAGS amplifies the DNA or RNA of a pathogen during thermal cycling. This controlled temperature process activates the generation of fluorescent signals, which correspond to the presence of specific genetic markers of the pathogens being tested. As the amplification process occurs, the fluorescent signal intensifies, allowing for more accurate detection of pathogens.
precise temperature control reduces the chance of false positives or negatives,
This technology improves diagnostic sensitivity by ensuring that even small amounts of a pathogen’s genetic material can be detected. The precise temperature control reduces the chance of false positives or negatives, enhancing the specificity of the test. TAGS is especially useful in multiplex tests, where different fluorescent colors can indicate the presence of multiple pathogens in a single sample. This makes it valuable for screening multiple infectious diseases at once, as seen in tests like Roche’s Cobas Respiratory Flex test. Overall, TAGS technology leads to faster, more reliable results, improving diagnostic accuracy in clinical settings.
The test is based on temperature-activated generation of signal technology (TAGS), which integrates PCR testing with fluorescent color analysis and other sample data to deliver high precision in pathogen detection.
– While many conventional tests screen for about four genomic targets, Roche’s TAGS technology allows it to track as many as 15 different pathogens in one test.
– Clinicians can detect not only COVID-19, but also respiratory syncytial virus (RSV), multiple types of influenza, and several other respiratory viruses, with a single kit.
-Test is compatible with existing Roche instruments without the need for hardware or software upgrades.
– Clinicians can customize the test to focus on specific pathogens, depending on factors such as seasonality, geographic location, and the prevalence of particular diseases. This adaptability ensures that the test can be fine-tuned for the needs of different healthcare settings, making it a valuable tool for managing localized outbreaks or tracking seasonal respiratory infections.
Looking ahead, Roche has broader ambitions for its TAGS technology. The company plans to extend its application beyond respiratory viruses, to enable high-throughput testing for a range of pathogens and medical conditions. This move aligns with Roche’s strategy to stay at the forefront of diagnostic innovation and provide tools that support more comprehensive disease management across various healthcare scenarios.
Multiplex has arrived: bioMérieux Biofire’s SPOTFIRE Respiratory/Sore Throat (R/ST) Panel has been launched. It is a rapid diagnostic test designed to detect up to 15 pathogens that commonly cause sore throats and respiratory infections. These include viruses such as influenza, rhinovirus, respiratory syncytial virus (RSV), and SARS-CoV-2, as well as bacteria like Streptococcus pyogenes.
This panel utilizes a multiplex polymerase chain reaction (PCR) method, meaning it amplifies and detects the genetic material of multiple pathogens from a single sample, making it a highly sensitive test. The sample is collected via a throat or nasopharyngeal swab, and the results are delivered in about 15 minutes, offering rapid diagnosis.
Congress Passes One-Year Delay to PAMA Implementation, Again.
The US Senate and the House of Representatives this week again postponed but did not put away, legislation designed to force downward lab test reimbursement adjustments. The Protecting Access to Medicare Act (PAMA) is likely to be delayed one year. The PAMA price cuts slated to go into effect will now be slated for the beginning of 2026 and will be put off for another year. This makes the sixth year in a row Congress has passed a one-year delay to PAMA implementation.
ACLA said they are “pleased that Congress has delayed pending reductions,” but added that it still hopes to see passage of permanent PAMA reform. ACLA would like the SALSA bill, the Saving Access to Laboratory Services Act (SALSA), which wouldmake severalf permanent changes to PAMA supported by much of the industry.
Qiagen Gets Approval Under Rigorus IVDR Process
Speaking of delayed requirements, more stringent IVD regulations have been proposed but also delayed in implementation in Europe. One IVD isn’t waiting. Qiagen announced Thursday that it has obtained CE marking under Europe’s In Vitro Diagnostic Regulation (IVDR) for its PCR-based QiaStat-Dx instruments and assays. The new CE marking includes the QiaStat-Dx Analyzer and high-capacity QiaStat-Dx Rise as well as the gastrointestinal and respiratory panels that run on the systems.
Qiagen said they have transitioned more than 80 percent of 180 total products to the IVDR regulatory framework.
