Meridian Bioscience is a life sciences and diagnostics company specializing in developing innovative diagnostic solutions, reagents, and raw materials for infectious disease testing, oncology screening, and life science research.
Meridian Bioscience has two divisions: diagnostics and life sciences. Could you introduce us to the company and tell us how the Life Sciences division fits in its objectives?
Meridian was founded in 1977, became public in 1986 and went private in 2023. We have been continuously growing and innovating since the beginning. One of our major achievements was inventing the H. pylori stool antigen rapid test. Before this, testing for H. pylori required an endoscopy or a urea breath test—both complex procedures. Our discovery that H. pylori could be detected in stool was a breakthrough that significantly simplified testing and drove substantial growth.
Beyond diagnostics, we have also made significant contributions in the life sciences space. We have helped improve immunoassay technology for major diagnostic companies worldwide by providing increasingly advanced raw materials as their platforms evolved and became more sensitive. Our unique position allows us to both develop tests and support other companies in the industry with high-quality reagents and solutions. This became particularly crucial during major public health crises, such as the Zika outbreak in 2016, the Nipah virus outbreak in India, and, of course, the COVID-19 pandemic.
Could you expand on Meridian’s role during the COVID-19 pandemic?
We were alerted as early as December 2019 by our office in China, which warned us that this was going to be bigger than people realized. Acting quickly, we began developing solutions even before the virus was declared a global emergency in March 2020. We rapidly introduced a master mix to help diagnostic companies create qPCR tests for detecting COVID. When the industry shifted its focus to serology and antibody detection, we swiftly developed the necessary antigens for those assays.
As testing evolved, we responded by providing highly sensitive antibody pairs for antigen screening tests which became the most practical tool to detect infection. Additionally, we tackled challenges in molecular diagnostics, such as eliminating the need for sample extraction kits that were hard to find due to supply shortages and creating solutions for more convenient saliva-based COVID testing. These innovations allowed for faster, more efficient, and more accessible testing. The pandemic tested our ability to scale up rapidly, and we increased our production capacity fourfold to meet global demand.
And after the pandemic, Meridian began focusing on oncology…
Yes, we asked ourselves how we could use the expertise we had developed to address other critical healthcare challenges. Cancer was the obvious next step—it continues to be a growing problem, and early detection is crucial. Personally, this is a deeply meaningful area for me, as I have recently lost loved ones to this horrible disease.
One of the most promising advancements in cancer diagnostics is liquid biopsy, which allows for non-invasive testing. Our master mixes, which are highly sensitive and capable of single-copy detection, are ideal for these applications. We launched our Liquid Biopsy Master Mixes at the end of 2023 into early 2024 to help developers create more effective cancer screening tests. This marks an important new chapter for us, as we leverage our deep expertise in assay development to support the future of cancer diagnostics.
Is Meridian innovating proactively or reacting to client demands?
Innovation must have a purpose—you cannot just innovate for the sake of it. However, the key is to anticipate needs and move faster than anyone else. Being able to predict industry trends and respond before the demand fully materializes gives us a competitive edge and allows us to provide real value.
For example, looking ahead, we have focused on improving workflows for next-generation sequencing (NGS), which is a key technology for cancer screening. A major challenge in NGS workflows is enzyme stability, so we developed a proprietary enzyme and buffer system that allows for lyophilization of all steps in the process. This led to the launch of the first-ever lyophilized NGS library preparation kit, eliminating the need for cold storage and simplifying automation. Our role is not to commercialize this directly but to provide the technology to major players in the NGS market and help them improve their workflows.
So Meridian’s Life Science business prefers to work behind the scenes, in a sense?
Exactly. Our strength lies in developing innovative solutions that enhance the capabilities of well-established industry leaders. We thrive in times of crisis and rapid change—whether it is responding to a global pandemic or advancing cancer diagnostics. By continuously refining our technology and staying ahead of industry needs, we ensure that our partners have the tools they need to succeed.
We work with industry giants as well as companies in between, ensuring that advancements in diagnostics and life sciences reach the market effectively. Some of these larger corporations already have established relationships with contract development and manufacturing organizations (CDMOs), but we also play a crucial role in supporting both the CDMOs and the R&D departments within these major companies.
What are the main challenges you face in keeping up with industry trends?
The biggest challenge we hear from our customers is the need for speed. They need faster R&D, quicker product approvals, and more efficient launches. The industry also demands accessibility, particularly after the pandemic, when at-home and point-of-care testing became widely accepted. This means tests must be stable, affordable, and convenient without compromising performance—all while costs are being squeezed across the board. The demand now is to be cheaper, faster, and better. That may sound like a cliché, but today, it is a necessity for survival.
Could you share more about your foray into non-animal derived assays?
Immunoassays require interference blockers—extra antibodies that ensure accurate results by preventing false positives or negatives. Traditionally, these blockers are derived from animals, and we are one of the largest global manufacturers of immunoassay blockers. The most widely used blocker, mouse IgG, requires about 80,000 mice per kilogram, and we produce this in the hundreds of kilograms annually.
Recognizing both the sustainability concerns and the shortages experienced during the pandemic, we developed a recombinant version of mouse IgG that is lab-produced, scalable, and performs equal to or better than the animal-derived version. We have since expanded this approach to other immunoassay blockers. On the molecular side, all our master mixes are entirely free of animal-derived components, aligning with our vision of a more sustainable and scalable future.
Where do you see Meridian’s Life Science Business in the next few years?
I am excited about the discoveries we are making, particularly in NGS. Our fully lyophilized library preparation solution is designed to give developers a walk-away solution—making cancer screening more accessible and cost-effective. We are also advancing isothermal amplification technology, which could have a significant impact on diseases like tuberculosis.
Looking ahead, we see tremendous potential in companion diagnostics and personalized medicine. The industry is shifting in this direction, and 2025 marks an inflection point where we must develop better solutions to meet these evolving needs. Anticipating the future of diagnostics and staying ahead of industry trends is what truly excites me.
