Boule Diagnostics brings hematology testing to the point of care

A complete blood count (CBC) is listed as one of the tests requested with short turnaround time, as the results give a first indication of many illnesses. In addition to being a decisive starting point for diagnosis, CBC testing is also used in monitoring of changes in patients’ health as well as of disease progression and treatment efficacy. A CBC test is, therefore, one of the most requested clinical tests, which has not least become evident in the recent Covid-19 pandemic.

The pandemic has made healthcare leaders reassess their needs. In the future, a larger part of diagnostic testing is expected to take place closer to the patient. At the same time, a shortage of healthcare professionals is foreseen. The need for improved, yet less expensive healthcare increases the requests for small and less costly analyzers that can be used at point of care. These needs pose challenges to engineers to develop cost-efficient analyzers that are simple enough to be used with a minimum of training. Because many CBC tests are performed each day, sample flagging with improved specificity and sensitivity is a necessity to reduce the number of false-positives and false-negatives that require cell morphology assessments by experts.

Boule Diagnostics, formed by the acquisition of the Swelab and Medonic brands in the late 90s, always had its focus on the decentralized hematology testing market. Whereas throughput is greater in central laboratories, decentralized testing facilities, such as primary care units are more in numbers. The target end-user of the company is reflected in many purpose-designed instrument features. For example, the micro-pipette adapter (MPA) aspiration method allows analysis of capillary blood directly from a fingerstick sample without prior preparation. The capability of analyzing capillary blood facilitates sampling and omits the need of the phlebotomy expertise and equipment needed for a vein puncture. Another example is the space-saving automation solution that simplifies pre-analytics by providing proper, yet gentle, pre-analytical mixing of blood samples collected in hematology tubes. The compact design allows analyzers to be installed in confined spaces, and their robustness ensures instrument uptime by reducing maintenance and service calls.

To meet customer needs also in the future, Boule has put large efforts into the development of its next-generation hematology platform. The new platform is designed to bring clinical utility through improved measurement algorithms. Instrument uptime is maximized by design solutions that reduce wear and tear of components. The fluidic system, for example, is designed without moving parts that may become worn out and need to be replaced. Connectivity is enhanced to support customers in maintaining compliance with regulatory guidelines. The new platform will be supported by a web-based data management software, allowing instrument coordinators to monitor performance of analyzers installed outside of the hospital laboratory from virtually anywhere.

Boule works closely with end-users to understand their needs and to ensure that products meet their expectations. Investing in own-developed technologies facilitates maintaining a unique offering also in the future. A portfolio of products that are purpose-designed for the target customer is what has made Boule one of the leading providers of hematology solutions for the decentralized testing market in many regions.

Although product design and development will remain within Boule, strategic partnerships with local contract manufacturers will reduce costs and allow for better meeting the high demand in fast-growing emerging markets. In India, a royalty manufacturing agreement has been signed with Q-Line Biotech. The 1200-sq. m reagent manufacturing facility, based in Lucknow, Uttar Pradesh, is expected to be up and running by the end of 2023, and licensed instrument manufacturing is in the planning phase. Boule has a long history with Q-Line Biotech, as a distributor of Boule products on the Indian market, and the agreements on local manufacturing will help grow and expand the mutual business in India. Local manufacturing supports the Make in India initiative by the Indian government that encourages companies to invest in India and facilitates doing business with Indian customers.

Although Boule’s own manufacturing is relatively energy-efficient, transportation of goods along the value chain has a significant environmental impact. Local manufacturing closer to our customers contributes to reducing energy consumption and emissions.

Boule’s sustainability work covers the complete product supply chain, to protect and improve the environment and the health and well-being of employees, customers, patients, and the societies in which the Company operates.