Tried and Tested

Sekisui Diagnostics
Written by Pauline Muller

One rarely thinks about the mind-blowing amount of technology that goes into creating accurate medical diagnostics. These tests can be those performed in a laboratory (like when you get your blood drawn) or in a rapid format, also known as point-of-care tests. Both types of tests aid in the diagnosis and monitoring of a broad range of conditions from flu to strep throat, pregnancy, cholesterol levels and liver function. Luckily, there is an international diagnostics giant that does think about it. Sekisui Diagnostics produces rapid tests and reagents so doctors can improve health and even save lives.
The industry stalwart has been a trusted supplier of next-generation diagnostic technology for over 35 years. This past summer, its new HbA1c diabetes test achieved FDA clearance. The hemoglobin A1C test is a very important blood test used in the diagnosis of this potentially life-threatening condition.

“The interesting thing for the North American market is that the Food and Drug Administration (FDA) has allowed certain companies to achieve what is called a diagnostic claim for human hemoglobin A1C testing. This means a physician can run one test and diagnose based on that result,” Lee Lipski, senior vice president and general manager of the business unit which focuses on in vitro diagnostic medical devices.

The company has also introduced its first new molecular test that was developed in collaboration with Mesa Biotech. The Silaris™ Influenza A & B test offers accurate detection at the point of care for optimum flu management by combining the simplicity of traditional rapid tests and the latest in molecular diagnostic methods. The test is easy to use, cost-effective and highly accurate in its diagnosis.

“We’re very excited about this test because very often customers get used to a particular way of running a test. This technology allows the customer to continue using the existing visual style of testing combined with the sensitivity provided by a molecular diagnostic method,” says Lee.

With this test, a nasal swab sample is introduced to the product, and the customer can read the test in the same way as they would a traditional point-of-care test by simply looking at the color intensity of different lines in the test window.

The company’s product lines include clinical chemistry systems and reagents, coagulation systems and reagents, point-of-care immunoassay, molecular point-of-care systems, rapid tests, enzymes, specialty biochemicals and biopharmaceutical products.

Medical practitioners and laboratories around the world benefit from the company’s global reach as it distributes throughout the Americas, Europe, the Middle East, and Africa. This year’s overall investment in process automation includes its San Diego, California, facility where greatly improved production volumes support the global expansion of its rapid test and point-of-care test products.

And these are not its only great improvements this year. Part of Sekisui Diagnostics’ mammoth achievements for 2018 includes a number of development and regulatory goals. This includes securing 510(k) clearance by the FDA for its CP3000 blood coagulation instrument and for its SK500 clinical chemistry instrument.

This high-performance product provides the power needed to optimize its reagents in clinical testing. The SK500 comes with a full choice of reagents that are developed and packaged specifically for the system. This includes a comprehensive metabolic panel (CPM), which is a collection of fourteen blood tests that give doctors insight into organ health, blood sugar levels, and the possible cause of certain symptoms. Tests include lipid panels used in identifying and treating cardiovascular disease by measuring the levels of different types of lipids, like cholesterol, in the bloodstream. The testing device creates a smooth workflow and a quick turnaround time for sample testing.

Historically, Sekisui Diagnostics only supplied consumable test components to the diagnostic test market. To offer a more comprehensive solution, the company joined the instrumentation field by partnering with key industry players to create the top-quality point-of-care immunoassay and molecular diagnostic tests for which it has become known.

The company moves fast and goes to great lengths to maintain a very close connection with its customers. This not only affords the company a great means of growing and developing, but also offers a prime vantage point from which to gauge changing market trends and needs.

Being in such close partnership with its customers, Sekisui Diagnostics believes very strongly in honouring its social responsibilities. One contribution to this commitment is aimed at programs that reduce its carbon footprint, contribute to the wellbeing of the global community, and ensure the cultural diversity and integration of its workforce. It is also dedicated to complying with and respecting human rights.

Thanks to its innovations and continued growth, the company is set to reach its goal of $210 million in annual revenue this year, an improvement of fifteen percent over 2017. Sekisui Diagnostics is headquartered in Lexington, Massachusetts, and with over four hundred employees, it forms part of the greater global Sekisui Medical Group which employs around 2000.

With plants in the United States, Canada, and the United Kingdom, Japan, China and Singapore, its parent company, Sekisui Medical Group, always attempts to manufacture its products close to its end-users’ markets. This permits it to be competitive while delivering the best quality diagnostic tests possible.

The company’s facility in Charlottetown, Prince Edward Island was started by a local Prince Edward Island entrepreneur who produced reagents. It was purchased in 2007 by an American company, Genzyme Diagnostics, which became Sekisui Diagnostics when it was purchased by Sekisui Medical Group in 2011. “We’ve been working as Sekisui Diagnostics since 2011, but we’ve been doing this kind of chemistry since 1971. Our history of and commitment to producing high quality medical products on PEI has fueled significant growth year over year,” says Brian Stewart, Plant Manager and Director of Manufacturing at the Prince Edward Island operation.

Since then, the company has added over fifty full-time jobs and has increased its revenue significantly. Its PEI facility is owned by the provincial government with which it enjoys a very strong relationship. “We work with them on various programs which allow us to run our operation very efficiently and competitively in the global market. We have invested particularly heavily in the infrastructure of the site in the last two years to bring it up to world-class standards,” says Brian. This project has seen addition of LED lighting, epoxy flooring, and an expanded manufacturing space to increase production capacity and match the high standards of its outfit in Japan. It has also brought about valuable knowledge transfer from Japan to Canada. Expansion to the Canadian site has brought welcome investment and higher-paying career opportunities to the region.

“We are one of the top three largest companies in the bioscience sector on Prince Edward Island, so there’s a lot of focus on growing the industry here. By us growing and bringing resources to the island, the government has also backed the industry. There is now a huge expansion of incubation bioscience companies that have set down roots here,” says Brian. To ensure a steady stream of top bioscience experts, the company collaborates with the local college and the University of Prince Edward Island on industry-specific programs.

Among its many great international achievements that showcase its phenomenal innovation and technology, Sekisui Diagnostics is also acknowledged as a well-respected employer. In testimony to this, the editors of Canada’s Top 100 Employers have honoured the PEI Site as a Top Employer two years in a row (2018 & 2019) out of 9,800 companies.

“These national awards have helped us draw in top talent, not just from the region, but from across Canada. So, as we grow we are getting great people who want to come and work for us. It has also given us momentum on our employee morale and retention,” says Brian.

This industry leader has withstood the test of time while demonstrating true excellence in many fields, keeping it at the forefront of world innovation.



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