“We are helping to bring innovative diagnostic test kits to market”
21 DEC 2020
Yves Dubaquie, Head of Diagnostics Solutions, explains how we support Covid-19 testing.
Yves, your team supports more than 35 testing solutions. Can you tell us how you are collaborating with the developers and manufacturers of testing solutions?
We provide critical raw materials and services to in vitro diagnostics manufacturers. We don’t make and sell the test ourselves, but by providing our partners products and services such as custom manufacturing and R&D support, we are helping to bring innovative diagnostic test kits to market. But we don’t stop there. We also believe it is critically important to partner with our customers to develop robust supply chains to ensure they can deliver tests to those who need it across the globe.
What different kinds of Covid-19 tests are you supporting?
I am proud to say we are supporting more than 35 testing solutions and within those efforts, we are supporting three different types of Covid-19 tests that are at the forefront of helping to detect and diagnose Covid-19.
The first is Molecular / PCR tests, which is the current gold standard of tests, as it is highly accurate and sensitive. Through these tests, we help detect active Covid-19 infections by detecting the presence of SARS-CoV-2 genetic material (viral RNA) in a patient’s sample.
Secondly, we supply critical components like membrane, beads, and antibodies for Rapid Antigen tests. These tests also measure active Covid-19 infections, and use antibodies to detect protein fragments from the virus. This test is also quite accurate, but slightly less so than PCR, however it has the advantage of being run at point-of-care, allowing for faster results in a less regulated environment. Many of the tests available today, however, require follow-up with a PCR-based test as confirmation.
Finally, we are supporting Serological / Antibody tests which do not measure the virus itself, but the patient’s response – namely, has the patient developed antibodies in response to Covid-19. The clinical utility of these tests is still being determined as the presence of antibodies does not indicate whether a patient has an active infection and could pose a transmission risk, or if the patient has developed any immunity to Covid-19. However, these tests will likely become more important in population studies or complement an active vaccine once in the market.
It’s important to note that our materials are critical components of technologies used to support treatment of Covid-19 patients – from diagnostic tests for potentially life-threatening complications, including blood coagulation, d-dimer and hemostasis to filtration technologies used in the production of convalescent plasma.
Testing is key to managing and overcoming this pandemic, yet it still is quite complicated and often takes more than a day. What are the greatest challenges we must tackle to make Covid-19 testing faster and more accessible?
There are a variety of bottlenecks in the logistics of testing which, if we could manage, would give us more flexibility in making testing more accessible. One of the bottlenecks we have been able to address during this pandemic is sample collection. Take for example the nasopharyngeal swab, which requires that you go to a testing facility where trained professionals – dressed in full PPE – collect, prepare and ship the sample to a lab to be tested. In order to relieve this burden of time and resources on both patients and healthcare providers, there are now sample collection tests being made to be done at home, limiting your exposure to those outside of your home. Additional innovations with oral swabs and saliva-based tests are helping to make testing more accessible.
Similarly, to increase our overall testing capacity, we must also continue to focus on supporting a two-pronged strategy: enabling low-cost, distributed rapid point-of-care tests and the development of high-throughput technologies for centralized labs. One example is our new collaboration with Mammoth Biosciences for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test. Mammoth’s high-throughput systems will be compatible with both nasal swab and saliva samples and are targeting approximately 1,500 tests per eight-hour shift with minimal user interaction. Mammoth Biosciences plans to submit the assay for FDA Emergency Use Authorization later this year and it’s clear to see this could have a significant impact on the rate of testing, and the subsequently, help mitigate and control the viral spread of Covid-19.
What technologies do you consider most promising when it comes to testing?
When I think of further innovations to diagnostic tests, I think one area that is truly important is developing tests that do not require sophisticated instruments or highly skilled lab technicians. One example of this is a colorimetric test, where a sample is mixed with an enzyme and this reading happens through a color change. This is a technology called LAMP, which is an alternative to PCR, that does not require sophisticated equipment to complete the analysis. For example, many existing tests require a thermocycler, which is typically available only in certain labs to cycle the temperature of the sample as it is being processed. The colorimetric test could be an interesting test because it would not require such sophisticated instrumentation and could provide an easy read out.
I have already mentioned next-gen sequencing tests, but it’s worth mentioning again. This technology is especially exciting when you think about the ability to process a batch of tests. This would mean we could have large amounts of samples, thousands of them, that are barcoded and processed simultaneously to diagnose patients faster.
Are there additional approaches to testing individuals that should also be pursued to get a better picture of the prevalence of Covid-19?
One of the positive side-effects of Covid-19 has been the rapid development of novel approaches to monitoring the spread of infectious disease. Recently, I was fortunate to be on a panel that explored different approaches to innovations in diagnostics and monitoring. During this discussion, I was joined by two fellow scientific experts who were at the forefront of developing and implementing two exciting approaches to monitoring the spread of infectious disease that are worth exploring.
The first is monitoring novel biomarkers, such as vocal acoustics which can picked up by digital devices to assess changes in health that could be indicative of a Covid-19 response. While not yet an approved diagnostic tool, this approach could be used as a first-line surveillance or screening tool to help detect changes and symptoms that would previously be indistinguishable – ultimately leading people to get tested, and potentially isolated, faster.
Additionally, wastewater epidemiology has demonstrated promise in helping to monitor the introduction and spread of infectious disease throughout communities and populations. A June 2020 study determined that both symptomatic and asymptomatic individuals shed SARS-CoV-2 in their stool, which is consistent with an April 2020 study that found most frequent shedding occurs in infected individuals immediately after contracting the virus. This is especially important when monitoring a virus that has such a long incubation period like SARS-CoV-2.
And these are just two examples! We are learning more every day and as a result, more innovative and targeted approaches are being developed to help combat Covid-19 as well as future infectious diseases.