In this interview, News-Medical talks to Andre Alfaro from nanoComposix (now a Fortis Life Sciences Company) about the possibilities lateral flow assays offer in both the present and potential post-COVID times
Can you explain what a lateral flow assay is and how this technology was initially developed?
Lateral flow assays have become a lot easier to describe after COVID because now we can point to an example that many people have seen.
A lateral flow assay is a rapid diagnostic capable of providing quantitative, semi-quantitative, or qualitative results in minutes. These assays are designed to be low-cost, simple to use so they can be deployed in almost every environment, and flexible for diagnostics in multiple applications.
Everyone is familiar with rapid COVID testing and pregnancy tests – both of these are lateral flow. Lateral flow is chosen for these applications because it is inexpensive, accurate, easy to use and ideal for when you need an answer quickly without calling on a professional.
COVID has expanded people’s knowledge of the benefits of lateral flow, and education was always one of the hurdles.
People have previously been scared of what they did not know. However, now with the global adoption of rapid diagnostics, people are interested in using these tests to monitor their own health. Am I too stressed? Do I have the flu? How are my organs functioning? All of which can be answered in minutes with a lateral flow test.
Thanks to COVID, a new world is being created, and it is a very exciting time.
Please provide an overview of nanoComposix’s (now a Fortis Life Sciences company) experience in developing lateral flow assay technology?
Our route into becoming a contract manufacturer for lateral flow started with nanomaterials. We are a reagents company that was founded in the early 2000s, and we began making nanomaterials that were predominantly aimed at the life science sector.
Although the applications for nanomaterial can range from drug delivery to anti-microbial paint, we found that many people were using custom nanomaterials of different sizes and different surface chemistries to develop diagnostics. It was then an easy decision to expand our capabilities to help client develop their products by utilizing our knowledge of materials, conjugation, and manufacturing.
nanoComposix (now a Fortis Life Sciences company) is now one of the more prominent contract research organizations and contract manufacturers in the United States. Day in and day out we support customers from early concept design through to commercialization.
No matter where customers are on the spectrum of development, for example, whether it is marker discovery to treat river blindness in Africa, if they have a concept but have no idea where to start, we can help with that. This may mean marker discovery, affinity reagent identification, customization of a test platform, scale up, supply chain management, or manufacturing.
The requirements of each test is different, so instead of using a one size fits all approach, we build custom solution for unique problems.
Image credit: Fortis Life Sciences
How has this field changed over the last few years, and how does nanoComposix (now a Fortis Life Sciences company) stay ahead of the game with respect to these changes?
The thing that has changed the most over the last two years is education. People now know what lateral flow is because COVID has forced people to develop this understanding. People know how to collect a sample, mix it with a buffer, add that solution to a strip, and interpret a result. Not too long ago, this would have been unrealistic as indicated by the number of Over-the-Counter (OTC) LFA tests on the market. The gap in complexity between a pregnancy test and a COVID test is significant, and we bridged that entire gap during the course of the pandemic.
Armed with the knowledge that we have billions of case studies of people effectively using an OTC lateral flow rapid test, companies are not investing in new innovative means of getting these tests into the hands of the everyday user for preventative medicine, health monitoring, tracking, etc.
We call this individualized healthcare. People now feel more comfortable with a platform for health monitoring they can use at home instead of scheduling an appointment at a doctor's office.
People have often seen a doctor and had a sample of blood drawn to check for cholesterol or other things. I think it would be highly advantageous to be able to do that at home, for a fraction of the cost to the healthcare system and the individual.
Could you please explain some of the challenges associated with developing and commercializing lateral flows?
First and foremost is the challenge of developing the chemistry and biology happening on the strip. Lateral flow is a dynamic platform where we need everything to occur quickly in a very small space. Most central labs use big analyzers that can perform multiple steps to make the assay more specific or more sensitive. You don’t have that luxury in lateral flow.
The next challenge is developing a custom platform that meets all the product requirements. This may involve lots of customization. For example, do we need a custom cassette? Do we need specialized readers? All of these things depend on the target product profile, which sometimes introduces a lot of difficulties.
How do these challenges differ for global companies compared to smaller startup ventures?
The major hurdle facing smaller companies is they have to typically develop a platform from scratch, whereas larger companies are putting new tests on an existing platform. Usually, bigger companies already have a preexisting platform to integrate a new test into. That makes the pathway more streamlined and straightforward because there are less questions that need to be answered.
For bigger companies, restrictions on the design can be both good and bad because if we are using an existing platform and do not have the ability to turn all the knobs, it limits options around possible solutions.
While smaller companies have the added burden of developing a new platform, they also have the ability to customize every aspect of the platform to mee the need of the test they are developing. This means lots of possible solutions to potential problems during development.
There are good and bad scenarios for both small and large companies, and I would say that they are both on equal footing in terms of getting the product out the door, as long as they have funding to move it through that is.
Developing a commercial product is expensive, particularly if you have to go through clinical trials, so making sure you have allocated budgets beforehand is vital for any company.
Could you explain how nanoComposix (now a Fortis Life Sciences company) can help a customer overcome these challenges?
We can leverage our experience developing unique lateral flow platforms to accelerate development and truncate the time to market. Alongside our extensive knowledge of product development, we also have vertically integrated the critical components of product development under one roof for a seamless transition from development to commercialization.
We offer a combination of antibodies, nanomaterials, manufacturing capabilities and development expertise. That is what we bring to the table when customers work with us, and we can answer more of those research questions faster because we have integration across the board in terms of what is required for product development.
When people hear ‘lateral flow,’ their minds immediately turn to COVID. Apart from pregnancy tests, how could this technology be used beyond the current pandemic, and how else is it used currently?
This goes back to taking control and empowering people to monitor their wellness themselves. This involves decentralizing healthcare, so this is no longer just at a doctor’s office. COVID is shifting the narrative away from turning the hospital or your doctors office if you are sick, to being able to diagnose yourself in the comfort of your home.
This provides many benefits, including less chance of spreading infectious diseases and a reduced burden on healthcare systems.
As well as testing for infectious disease, we can also use lateral flow as part of wellness or what we call ‘surveillance.’ Surveillance involves tracking specific biomarkers associated with general wellness - for example, CRP or troponin – markers that are generally tracked every time you go to the doctor’s in case something is wrong.
Decentralizing healthcare, empowering individuals to take control of their health, and independently monitoring health all represent significant steps, and COVID was the precipitating event that prompted much of this.
What are some of the other areas in which lateral flow assays could potentially be used?
Lateral flow assays can be used for everything from infectious diseases to agriculture, and everything in between.
Veterinary care is one great example. Lateral flow is a great way to monitor the health of our pets. Whether it’s kidney function in cats, to see if the tick that bit your dog was positive for Lyme disease, lateral flow can help.
How are lateral flow assays used in neuroscience?
We can use lateral flow assays to track any chemicals or proteins associated with neurological health. Lateral flow assays are not a replacement for an MRI, but before you go and get these very expensive tests performed, we can help track and monitor specific markers to see if there may be a problem or not.
Traumatic brain injury is a great example of this. It is high-risk but hard to diagnose without scans, and a large volume of the people that go to the ER saying they have a concussion do not, but it is essential that they get tested.
It would make a world of difference if we could do this testing at home.
Can lateral flow assays be used in the detection and diagnosis of cancer biomarkers?
Absolutely, with the caveat that the road to commercialization is long. This is due to the risks associated with the test results, and as such, the FDA keeps a close eye on this.
As the consequences of a false negative cancer diagnosis are so severe, the validation process is long. That is why lateral flow is not widely used in that space yet. But we can do a lot of surveillance and monitoring because the biomarker library associated with specific cancers is relatively large and well characterized.
For example, post-op surveillance for reoccurrence is an excellent use for lateral flow. Diagnostics are also a very good use of lateral flow. After clinical studies are complete, this would be the next step, as we need longitudinal studies to show that tests are accurate enough not to pose any risk to people.
How can lateral flow be used in food safety and food quality inspection?
There are many applications of lateral flow in the agriculture space, from testing livestock to ensure that they are healthy and not spreading diseases to checking for GMO content to meet food standards.
There is a multitude of ways we help the food industry already; livestock and GMO content are just the tip of the iceberg.
Do you see lateral flow assays being more widely used in the future?
I do, mainly because they are cheap and easy to use. If you can make something inexpensive and easy to use, there will always be a use for it.
The big question is whether lateral flow assays are sensitive enough or accurate enough, and this depends on the test itself. Some tests have been shown to be more accurate than PCR, for example, but every assay is different.
This high performance is thanks to innovations in this field, like the nanoComposix (now a Fortis Life Sciences company) gold nanoshells which provide higher sensitivity. If you meet the sensitivity required for the test using just a simple lateral flow, then there is not much competition in terms of cost and ease of deployment.
How will nanoComposix (now a Fortis Life Sciences company) ensure the company is at the forefront of a potential lateral flow revolution?
Being one of the largest assay development houses and high throughput manufacturers in the country, nanoComposix will always be at the forefront of the lateral flow revolution. We are continuing to innovate and develop new nanomaterials and proteins to make better assays in the future, and are fully integrated to rapidly incorporate these new products into any lateral flow product
About Andre Alfaro
Andre Alfaro earned his B.S. in Human Biology and B.A. in Clinical Psychology from University of California, San Diego, where he spent several years characterizing surface markers on cancer stem cells for potential use as targets for nanoparticle delivery systems of cancer vaccines. He then joined Astute Medical in 2008 where he began a career developing and commercializing dozens of in vitro diagnostic tests on both the lateral flow and ELISA platforms for multiple disease indications. His work on the identification of acute kidney biomarkers led to a successful de novo 510(K) submission and CE mark of the NephroCheck test. In 2018, he joined the nanoComposix (now a Fortis Life Sciences company) team to bring his 10+ years of development, quality and regulatory training to the lateral flow group.
About Fortis Life Sciences
Fortis Life Sciences is a strategic platform providing capital, expertise, and operational resources enabling the growth and success of founder-led life sciences tools companies. Fortis Life Sciences was founded in 2020, with the vision of creating an exceptional life sciences company focused on offering world class products coupled with a best-in-class customer experience.