Meridian Bioscience Inc., located in Cincinnati, is an international producer and distributor of a range of diagnostic test kits. While Meridian doesn’t make a COVID-19 test kit, it is using its proprietary technologies to help those developing tests for COVID-19.
Meridian’s hope is that diagnostic companies around the world will be able to use their specialized enzyme formulations to develop COVID-19 detection assays with greater sensitivity, faster run-times and formatted for high throughput testing.
We checked in with Charlie Wood, Vice President of Corporate Strategy of the company, for a Q&A.
How is Meridian helping to address the shortage of COVID-19 test kits in the U.S.?
Meridian does not make a COVID-19 diagnostic test kit. However, our Life Science division is a manufacturer of key raw materials critical in any molecular diagnostic test.
We have molecular master mixes that perform well in tests designed to detect DNA and RNA viruses and their resulting infections including SARS-COV-2.
Additionally, we are now offering samples of our master mixes free of charge to diagnostic testing companies that are working on COVID-19 tests, which should accelerate the development of new tests and hopefully help to ameliorate the shortage as more tests become available.
How do your formulations fit into the development of test kits?
Master mixes are a critical component of every molecular test kit. A diagnostic company needs to add the target-specific primers and probes (in this case for SARS-COV-2) and the kit is complete.
The type of formulation used depends on whether the kit is in liquid or dried format. Dry format provides for extended storage and simplifies shipping and storage for the end customer which minimizes temperature control requirements.
Does it meet WHO, CDC, and FDA guidelines?
All of our products are manufactured under ISO13485, which is a quality system needed for medical device regulations. Any diagnostic company can use our products and feel confident that as a supplier we can meet their requirements.
Diagnostic companies can then apply themselves, with their finished kit that includes our reagent, to the regulatory authorities of their choice to get FDA, CFDA, ANVISA, or whichever other certification depending on their market.
Much of the early work was done for China, correct? How is Meridian working with U.S. companies?
You are correct that most of the diagnostic test development started in China, but there are a multitude of companies across the globe developing tests for COVID-19. Meridian is working with companies in the U.S. and Europe in the same way that we are working with companies in China and elsewhere.
How are you keeping up with demand for your products to meet the current COVID-19 testing crisis?
We are not a “just in time” type of business, given we are a critical supplier of the healthcare industry; we keep inventory of both finished goods and raw materials on hand to facilitate our ability to flex to market demands.
Additionally, we have been working with our suppliers to ensure we can continue to meet the demand from our customers.