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Beckman Coulter Total Lab Automation System Targets Testing Errors in Preanalytical Stage

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BARCELONA, Spain (360Dx) ­– Beckman Coulter this week publicly showed off its new total lab automation system, an instrument that company officials said would be a significant driver of the company's continued rejuvenation after it stumbled about a decade ago.

The Brea, California-based company, a subsidiary of diversified conglomerate Danaher, displayed its DxA 5000 platform here at the EuroMedLab 2019 conference in a sort of formal debut for the modular platform that allows laboratorians to essentially put a blood or urine sample in the instrument and then walk away.

According to company officials, the system's breakthrough capabilities is its potential to eliminate test errors in the preanalytical state. Such errors, Beckman Coulter said, contribute up to about three-quarters of all incorrect test results.

The DxA 5000 can be used with tubes of multiple sizes that are already on the market, and it can assess sample quality, and screen each sample at different points. It can detect test tube parameter, including sample volume, sample identification, tube type, caps that are colored based on the priority of the test, orders pending, and tube weight. Further, it checks for sample volume during precentrifugation, post-centrifugation, and before sample storage to ensure enough sample is available for an ordered test.

"All those preanalytical errors, we prevent and we [take] out … at the beginning" of the testing process, Simon Kasse, senior global product manager (DxA 5000) for Beckman Coulter’s Workflow and Informatics Business, said in an interview.

Because the DxA 5000 checks the sample volume at three different points, it can determine whether there is enough sample to run the test ordered. If there is not enough sample "we can customize what the order of those tests should be, based on the customer's requirements," Kathleen Orland, vice president of global marketing for Beckman Coulter, said.

If, for example, both a stat and a routine test are ordered for one patient sample, but not enough sample is available for both tests to be run, the DxA will prioritize the stat test over the routine test. A message is then sent to the hospital information system alerting technicians that more patient sample is needed.

Because the system can determine the volume of a sample, it can also perform centrifugation of sometimes hundreds of tubes in a balanced manner, Beckman Senior Vice President of Products and Services John Blackwood added.

"That contribution of tube inspection, rapid loading [of tubes], and centrifugation into the sample manager provides the fastest inlet-to-track solution for any product on the market," he said.

For troponin I testing, for example, Kasse said, the total turnaround time from the sample being put into the DxA 5000 to getting a result is less than 30 minutes, compared to about 90 minutes with other automated systems.

Additionally, the system's "distribution manager," run by the company's Remisol Advance middleware, allows a customer to prioritize which category of tubes need immediate attention, which tubes need less attention, and which tubes need the least attention. Bottlenecks of tubes on the track have been an issue for many automated lab systems, Kasse said. The DxA 5000 eliminates that, he said, as the distribution manager prevents those tubes with lower priority from making it to the track before those with higher priorities.

In designing the system, Beckman Coulter spoke with 170 customers in 20 countries to get their feedback about what they considered to be pain points in their daily work routines. While Beckman Coulter's Automate 2500 family of automated systems had already been on the market for several years, the DxA 5000 is a grade above the older platform, Beckman Coulter executives said, and is not viewed as a next iteration of an existing technology.

At the conference on Monday, Martin Langan, manager of blood sciences at Countess of Chester Hospital in the UK, described his facility's decision last year to replace Beckman Coulter's Power Processor laboratory automation systems after 10 years. At Beckman Coulter's suggestion, it looked into the DxA 5000, which was not yet available at the time.

Since switching over to the new platform in December, the number of tests that have had to be done after the end of the regular workday due to an inability to get them done in time has decreased 27 percent, Langan said. He also reported faster results on the DxA 5000 for certain tests, including potassium, which improved more than 22 percent, and troponin, which improved almost 18 percent. Langan added that while implementation of the DxA 5000 has not led to a reduction in laboratory staffing, it has allowed the hospital to maintain its staffing levels without having to hire more personnel, despite a greater workload.

The price of the DxA 5000 will depend on the configuration of the system being bought by a customer but is "competitive" with other systems on the market, Orland said.

The platform is meant for high-volume labs due to its modular design, and it can handle anywhere between 800 to 5,000 tubes a day, Orland said, adding the company is working on a version of the DxA 5000 that would handle fewer than 800 tubes a day. That system could make it to market within the next 12 to 18 months, she said.

The DxA 5000 also represents an important marker for Beckman Coulter since being acquired by Danaher in 2011. At the time of the buy, Beckman Coulter was struggling on multiple fronts. Unreliable test results from its Accutn1 troponin test kits led to the tests being eventually recalled. The firm also ran into trouble with the US Food and Drug Administration for what the agency viewed as improper marketing of the test, and its former president, CEO, and Chairman Scott Garrett eventually resigned.

After the purchase, then-Danaher President and CEO Lawrence Culp spoke openly of the need to improve Beckman Coulter operationally and to replenish and reinvigorate its R&D pipeline.

More recently, though, Beckman Coulter has been a driver of revenue growth for Danaher, and during the first quarter of this year, revenue for Beckman Coulter's life sciences segment grew in the double digits year over year, while its diagnostics revenues were up in the mid-single digits.

During the past several quarterly earnings conference calls, current Danaher President and CEO Thomas Joyce has also taken note of the DxA 5000 and its potential to improve the clinical lab workflow, reduce costs to labs, and provide a boost to Beckman Coulter's diagnostics business.

"It's taken a while for that pipeline to move," Blackwood said. "I think this DxA 5000 is very important to the pipeline. It's a foundation to scalable automation, it's automation for our customers. … But it's actually the beginning of a very rich pipeline that's really starting to roll right now," he added.

So far, about two dozen orders for the DxA 5000 have been placed around the world. It has received CE marking and approval from China's National Medical Product Agency, formerly the China FDA. The firm filed for US FDA clearance of the platform in February.