Saving Lives with Faster, Better DiagnosticsBy Miriam Bello | Fri, 11/06/2020 - 14:11
Q: bioMérieux had an active response to the COVID-19 pandemic and developed a diagnostic test, how did the company develop the test in such a short timeline?
A: Numerous teams, such as Regulatory Affairs, Quality, Product Labelling and Documentation, Industrialization and Production, Quality Control and Clinical Affairs, were mobilized to support the availability of the new test as quickly as possible. This project succeeded so quickly because everyone was aware of their responsibility and helped on top of their routine activities. It is an example of our spirit of collaboration and exceptional efficiency. In fact, we currently have not only one but five tests available.
Q: How did bioMérieux’s technology and previous expertise helped the company in creating this solution?
A: In less than two months, bioMérieux was able to develop and brought to market its first PCR diagnostic test for the new coronavirus. This challenge was met thanks to the expertise and exemplary mobilization of multidisciplinary teams that were set up to support the availability of the new test as quickly as possible.
A COVID-19 singleplex PCR, our second of five solutions for diagnostic use as part of bioMérieux’s strategic response to the COVID-19 pandemic, was rapidly developed thanks to a combined result of the extensive effort and dedication of our employees, the assistance of our partner Midwest Research Institute Global, and the confidence entrusted to us by the US Department of Defense. And our third test, an expanded version of the second test, started its development as a new panel that includes SARS-CoV-2 in addition to 21 other common respiratory pathogens that delivers results in approximately 45 minutes.
Finally, based on years of experience in developing immunoassays, bioMérieux worked closely with several hospitals to develop and validate the performances of two tests to identify in less than 30 minutes the presence of antibodies in people who have been infected with SARS-CoV-2. These last tests complemented our three already launched molecular tests for the direct detection of the virus. Offering complementary testing solutions to laboratories is crucial to help overcome this pandemic. True to its commitment to serve public health, bioMérieux is one of the few players to propose a complete diagnostic solution for COVID-19 disease.
Q: What are the unique benefits of the diagnostic test? How does it compare to others in the market in terms of cost, accuracy, time to get results, scalability and ease of use?
A: All of our tests comply many international accreditations thanks to their excellent performance. In particular, our PCR Multiplex solution has great advantages thanks to its capacity to simultaneously detect several pathogens than can cause respiratory infections including SARS-CoV-2, Influenza and other viruses and bacteria in only 45 minutes, which will be highly relevant during winter period. Our solution is highly accurate, cost-efficient, does not requires complex infrastructure or specialized personnel on molecular biology, and it is scalable with the capability of processing up to 264 tests per day.
Q: How is bioMérieux working to distribute the diagnostic test it developed as far as possible?
A: bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors, working closely with private and public institutions to facilitate availability and access to our tests.
Q: What is bioMérieux’s formula to provide high value diagnostics and pioneering diagnostic innovation?
A: We offer complete solutions that focus on patients from the moment they enter the hospital to when they leave. In the field of microbiology, we are leaders not only in the area of bacteria but also viruses and parasites. Our state-of-the-art diagnostic equipment allows a diagnosis to be done in under an hour, which means a patient can get help faster and more effectively. Our diagnosis solutions reduce the amount of human error that can lead to a misdiagnosis and decrease the application of inappropriate treatments. They also help hospitals reduce the time allotted to patients. Currently, a diagnosis can take days. This will allow a hospital to help more people and at the same time save money.
Q: How relevant is the health sector for bioMérieux in comparison to other sectors where it has presence?
A: Our group consists of five companies, three of these dedicated to R&D, one focuses on food and pharmaceutical security and the fifth is focused on clinical diagnostics. Here in Mexico, the group’s activities are split about 80 percent in the clinical area, and 20 percent in the industrial sector. We work in both the public and private sectors. The majority of our clients are clinical laboratories, but the number of hospitals that have their own laboratories is increasing. In the industrial area, we work mostly with food and pharmaceutical companies. We provide technology that can detect problems opportunely, giving businesses a better workflow and the ability to produce better products. If a batch is cleared quickly, then it can also be sold more quickly. In the food sector, we work with products such as eggs, chicken and beef.
Q: What are the biggest challenges your clients face?
A: A major challenge we see is automation and the ability to integrate systems. There are very few suppliers like us that can offer complete solutions to achieve this. Our antimicrobial stewardship initiative is an example of a complete solution. This initiative helps to ensure that antibiotics are used adequately. Using the right type of antibiotic, dosage and administration for each specific patient is important in creating the desired outcome. But there is more useful information that can be gathered. For example, hospitals have their own flora of bacteria. This is relevant when providing treatment with antibiotics because they affect the patient. Knowing what bacteria are present and acting accordingly can save lives. Being able to gather information and manage it in a system is part of our offer.
Q: What actions is bioMérieux taking to help increase prevention through diagnostics?
A: In several countries, we are working on opportune diagnosis of kidney damage that will allow a doctor to intervene earlier and prevent actual harm to the kidney. Similar developments are taking place in other areas. In part, this approach is about breaking the paradigm that there should only be an intervention when there are symptoms.
Q: With respect to antibiotic resistance, what else can be done to mitigate this issue in Mexico?
A: We believe in collaborating with other parties. For this reason, we do not demand that our clients only use our products; they can also use the products and services of our competitors. Institutions are also good partners, such as the Ministry of Health, IMSS and ISSSTE. We are already working with several institutions, including a number of associations that are focused on antibiotic resistance. Here in Mexico, there is a network for epidemiological vigilance, with its main base in Monterrey. They gather data from hospitals to map the development of resistance. This can be done with a software that allows data to be processed immediately. Lastly, public awareness is also important. People need to know that they should not just take antibiotics without a proper study of their problem.
Q: What are bioMérieux main goals for 2020-2021?
A: The most important goal is to consolidate the area of rapid syndromic diagnosis. It is better to approach diseases as syndromes because they demand a broader analysis, versus a single-plex target analysis. The latter is more frequently used by doctors. They do a fast review of symptoms and decide on a treatment. However, this leads to more human error and can be ineffective. The line of products for rapid syndromic diagnosis has a market value of US$100 million. We intend to continue developing more types of panels and decrease the required time for a test. Now, we can make a diagnosis in 45 minutes for respiratory diseases for example, but in the future, it will take 20 minutes.
bioMérieux has more than 50 years of experience in the development of in vitro diagnostics. It offers clinical diagnosies products for laboratories and hospitals, as well as industrial microbiology solutions for the food, biopharma, veterinary and cosmetics sectors