In the last 12 months, Beckman Coulter has received a major boost to its long-term business development strategy of improving patient care and reducing cost by becoming a flagship brand within the Danaher portfolio of companies. Supporting and developing strong brands is a key strategy of Danaher, a global science and technology leader with an annual turnover of $16 billion. The Danaher business system invests only in high-quality businesses and then focuses on making them even stronger.
For example, this strategy has taken Leica to the number one position in its field globally for the quality of its products and services, and Radiometer to number one in point-of-care testing. Already number two worldwide in clinical chemistry and number one in laboratory automation, Beckman Coulter has moved from overall number 3 to number 2 globally now it is part of the Danaher portfolio.
As Leanne Annereau, Beckman Coulter’s marketing manager for Europe’s Northern Region, explains: “Beckman Coulter dedicates itself 100% to its laboratory customers and this will not change as a Danaher group company. Taking what is already respected in Beckman Coulter, we can now utilise the business expertise Danaher has in building companies and making them better. We will be focusing on what underpins Danaher’s core values for improvement – quality, delivery, cost and innovation. UK customers will begin to see what this means over the coming months.”
Flagship launch of the AU 5800 series
In line with one of the key Danaher principles, innovation, 2011 has seen the successful launch at EuroMedLab and the IBMS Biomedical Science Congress of the new AU5800 series clinical chemistry analyser, the highest capacity and most versatile clinical chemistry system on the market. The AU5800 is the first chemistry analyser to be launched under the Beckman Coulter name since the integration of the Olympus Diagnostics business in 2009. It is designed to connect to Beckman Coulter’s automation solutions, making it possible to integrate with the company’s clinical information systems and immunoassay testing platforms.
“The AU5800 series provides the right solution for mid- to high-volume laboratories because it delivers speed and throughput in a small footprint,” says Ms Annereau. “Other systems cannot match our throughput without installing more units, which take up more space, require more staff, and incur higher running costs (eg for calibration and QC). This user-friendly, highly efficient and economical platform fits very well with the increasing demand from NHS networks and our high-volume customers.”
Available in eight different configurations, the AU5800 series can perform from 2900 combined photometric/electrolyte tests per hour for the single unit, single ISE instrument (AU5811) up to 9800 tests per hour for the four-unit, dual ISE system. With the ability to upgrade with extra photometric units while maintaining single-platform efficiencies, the AU5800 series sets a new standard in productivity.
Immunoassay: patient-focused solutions
Beckman Coulter continues to grow its share of the immunoassay market. “Our strategy is to focus on the development of early diagnosis assays in key areas such as prostate cancer and women’s health,” says Ms Annereau. One such innovation centres on the anti-Müllerian hormone (AMH) and its role in determining a woman’s ovarian reserve (ie the number of eggs available for fertilisation). The quantity declines at varying rates with age or due to other factors such as cancer treatment.
Worldwide, Beckman Coulter is the only company with a commercially available in vitro diagnostics (IVD) or CE-marked assay for assessing AMH levels. It is currently available as a microplate-based enzyme-linked immunosorbent assay (ELISA) assay (AMH Gen II) but will be fully automated on the Beckman Coulter Access system in 2012.
There is increasing demand for this test as women delay having children and then find themselves having difficulty conceiving naturally. “Knowing ovarian reserve makes it possible, for example, to decide if fertility treatment would ever work,” explains Ms Annereau. “We need to have these answers for patients and their clinicians to make informed choices when faced with increased scrutiny into the cost of NHS-financed assisted reproduction.”
Anti-Müllerian hormone is also used in in vitro fertilisation (IVF) centres to tailor the women’s treatment, which maximises the clinical pregnancy rate while decreasing the risks associated with ovarian stimulation.
Another use for the test has come with improvements in cancer treatment, with many more children and women of child-bearing age surviving and being unsure if their fertility has been affected. Ms Annereau also points out: “We are seeing an increased demand to have access to AMH testing before treatment starts. A recent study has shown that AMH measurement when cancer is diagnosed can predict long-term ovarian function after chemotherapy. It may also be able to predict whether the chemotherapy would destroy fertility – again, vital information for directing NHS resources.”
Improving specificity and sensitivity of prostate cancer testing
Improving the accuracy of early diagnosis of prostate cancer is another key focus for Beckman Coulter. Hybritech, which the company later acquired, launched the world’s first commercially available prostate-specific antigen (PSA) assay and subsequently the Hybritech PSA assay set the gold standard for all PSA testing.
Prostate cancer is now one of the most common cancers in men, with incidence rising over the last two decades. In England and Wales, almost 35,000 new cases are diagnosed each year and, according to figures from Cancer Research UK, this results in 10,000 deaths annually. While a raised PSA level is known to indicate that prostate cancer is likely to be detected later in life, its lack of specificity leads to high levels of false positives at first screening. Approximately half of cancers detected in this way are indolent (slow growing) and would not cause death.
“Prostate-specific antigen is still useful and saves lives, as the recent European Randomized Study of Screening for Prostate Cancer (ERSPC) findings demonstrated. However, it has led to an unacceptably high level of unnecessary biopsies,” adds Ms Annereau. “And another challenge is that some cancers can be missed in the grey area of relatively low PSA levels (2–10 ng/mL). Our scientists have developed a new, more specific assay, the Access Hybritech p2PSA (which measures the [-2]proPSA molecule, an isoform of free PSA) and a multi-marker index, the Prostate Health Index (phi).”
This index is derived by combining the results of three automated blood tests – PSA, free PSA and the new p2PSA – and is now available in Europe for use on the Beckman Coulter Access 2 and UniCel DxI immunoassay systems. When phi is installed, the system automatically calculates and reports the Prostate Health Index results and helps to determine if a man should be recommended for prostate biopsy.
“Recent studies indicate that the multi-marker index (phi), calculated automatically on Beckman Coulter Access immunoassay systems, may have a significant role as a risk assessment tool in identifying prostate cancer,” she adds. The studies focus on the ability of detecting cancer in men aged over 50 with a negative digital rectal examination and who have PSA levels of 2–10 ng/mL. “There is also growing evidence suggesting that a panel of biomarkers, which includes the new biomarker p2PSA, may more accurately detect prostate cancer and may also distinguish between aggressive and indolent disease than is possible with total PSA alone.”
DxH 800 – improved service to clinicians
Beckman Coulter has also been driving innovation in its haematology offering, with two major developments. The first is the introduction of the small-footprint, scalable and high-specification UniCel DxH 800 Coulter Cellular Analysis System for mid- to high-volume laboratories. The second is it championing of the use of flow cytometry in the routine laboratory for validating abnormal samples.
“The DxH 800 has been a major success story, with 50 systems installed since 2011; the 50th being one of four in the Royal Devon and Exeter NHS Trust,” explains Ms Annereau. “It is the power of its precision and the accuracy of results reporting that has attracted such a high number of placements within the last year. Our customers tell us they have reduced the requirement for manual review and there is no need for manual intervention during repeat or reflex testing. The quality of diagnostic information available from the DxH 800 singles it out, enabling each laboratory to improve the disease management service it can offer clinical colleagues.”
Impact of flow cytometry
Beckman Coulter has been pioneering in Europe the routine use of flow cytometry in the haematology laboratory for validating abnormal samples, demonstrating that it delivers faster white blood cell (WBC) differential results with far greater consistency than manual assessment under the microscope. It also provides the laboratory with another way of improving the overall disease management service to clinicians.
Further improvements include new autogating software on the FC 500 cytometer, and a five-colour antibody cocktail, the CytoDiff, which uses six monoclonal antibodies to establish an extended-flow WBC differential. The CytoDiff can detect and quantify nine cell subsets.
Ms Annereau accepts that the UK already has a low manual review rate compared to some other countries. However, she points out: “With this technique, even small numbers of neoplastic cells, for example, can be detected among a population of normal cells, with a high degree of purity. A direct relationship between patient survival and the potential for proliferation of the tumour cells can be demonstrated for most neoplastic diseases.
“The value of automating a manual process is well understood, allowing greater workloads, improving turnaround time, while still providing objective and reliable results; and staff can focus on those samples where microscopic review is still essential. We are in the process of setting up a series of feasibility studies to demonstrate to UK customers how effective it can be.”
One European customer, Dr Olivier Pradier from the Erasme Hospital in Brussels and one of the world’s first users of the Hematoflow concept, spoke at a recent Beckman Coulter Core Blood Sciences User Group meeting held in Leicestershire. As he explained: “The secret is to forget you are working with a flow cytometer and think of this as any other haematology analyser, then you will understand it and know how to judge its productivity.”
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