NEW YORK (GenomeWeb) – A trial in the UK of Beckman Coulter's CE-marked molecular diagnostics system, the DxN Veris, has demonstrated enhancements to workflow and productivity.
In the analysis, published in the August issue of Pathology in Practice, laboratorians at the Department of Virology at Sheffield Teaching Hospitals NHS Foundation Trust examined the effect of consolidating four virology assays onto the DxN Veris.
These were compared to the lab's standard protocols for each assay. Specifically, the lab previously ran HIV-1 and hepatitis C virus tests on the Roche Cobas AmpliPrep TaqMan 48 analyzer; hepatitis B virus assays on Qiagen's QIAcube and Rotor-Gene; and cytomegalovirus on the Roche MagNa Pure with the Rotor-Gene.
By comparison, the automated DxN Veris can run cartridge-based assays for each of these analytes in a single-sample, random-access manner, and also performs sample extraction and detection.
The results showed a comparable performance in terms of precision, sensitivity, and linearity, the study said.
In each case, the Veris also decreased the number of rooms needed to store equipment, and reduced the procedural steps and number of consumables needed by at least half. The system also stores all reagents and consumables on board, further reducing hands-on time, the study noted.
"As the DxN Veris is a random-access platform, results were available every 2.5 minutes after the first result," the study noted. "None of the other platforms were true single-sample, random-access systems and so results were only available at the end of the batch run for these methods."
The trial used only a single DxN Veris system to obtain the favorable results, Richard Creager, senior vice president of molecular diagnostics and CSO of Beckman Coulter Diagnostics, confirmed to GenomeWeb in an interview last week.
Sheffield was one of the beta test sites for the DxN Veris, performing a combination of clinical evaluations and other assessments that the firm was testing before officially launching the product in May of 2015, Creager said. The system was CE-marked a year prior, as previously reported.
As a result of the beta experience, Sheffield wanted to do additional studies around workflow analysis, so Beckman Coulter coordinated with Nexus Global, a Texas-based consulting firm, to help the lab perform a clinical lab practices and productivity study, Creager said. For these studies, Beckman representatives were not present, but the firm did sponsor the workflow study as well as the beta testing.
The Sheffield lab had been experiencing a perfect storm of staffing reductions and increased demand, according to the study. The lab serves five teaching hospitals within the NHS trust as well as the local children's hospital. Three years ago, it saw its workday extended by four hours with no increase in staff numbers, and there was pressure to offer services seven days a week.
Further, the lab saw a loss of experienced staff. This phenomenon may in fact be common to many clinical labs in the US as well, Creager noted.
In recent years, a number of clinical lab professional organizations also described a "retirement cliff" in the workforce, with skilled staff being lost at high rates and a lack of well-trained replacements.
Preliminary data from the American Society of Clinical Pathology 2015 annual wage survey found that the mean age for medical technicians, clinical lab specialists, and medical laboratory scientists is 44.2 years, an ASCP representative told GenomeWeb in an email.
Creager also noted that this is a problem he has seen in labs all over the world, including his most recent visit with potential customers in Israel.
"They are, generally speaking, short staffed and technicians are generally older, so they're dealing with retirement issues, and there are not a lot of young people coming into the market — there tends to be turnover, and when there is, it's really hard to replace with experienced personnel."
The Veris system doesn't require as much experience to run, Creager said, and this "gives them another tool," to provide effective patient management. The system takes 20 minutes of training to use, according to the Sheffield study.
Sheffield is also similar to other molecular labs, Creager said, in that it is experiencing other key issues going on in the space. With increasingly aging populations around the world, chronic disease is on the rise, and new discoveries are driving new diagnostics and therapeutics, with the two often feeding back on each other, driving up testing volumes.
"At the same time, healthcare costs are under a lot of pressure, with governments trying to reduce spending," Creager noted.
As a consequence, there is a need in diagnostics, and in particular in molecular diagnostics, to improve productivity.
Labs also have to manage staffing levels, so increased demand and constrained budgets mean they either have to reduce headcount, or try to keep it the same but do more with fewer resources.
Furthermore, "a lot of the current technology is done in batch mode, and that means you have to wait until you get a bunch of samples before you can do the testing," Creager said, leading to labs not being able to get results out as fast as physicians would like.
In the Sheffield lab, a CMV result was taking up to a week to report results because there was a lower volume of tests needed overall, and the lab had to wait until there were enough samples to run batches.
The study showed DxN Veris enabled same-day turn-around time for most cases, helping the health system improve patient management.
Creager recently provided an update on the firm's plans to bring this system to the US, and said that it is remains on track with product launches around the world and is still targeting the next few years to enter the US market.