Q&A: Developing an at-home test for strep throat

Nathalya Mamane, chief executive officer and founder of RT MicroDx speaks to Med-Tech Innovation News about the development of an at-home test for strep throat. 

1. Tell us about the where the idea for this strep throat test came from?

The idea came to me as a parent of four children who understands the toll it takes on parents when the only option to test and diagnose your sick child is to go see a doctor, either at your PCP, urgent care clinics, or emergency department. Often, the only test that is performed is the strep test because it’s the only infection that requires treatment. All other infections are generally viral and only need time to resolve themselves naturally. 

Although it is easily treatable, undiagnosed, or untreated strep is highly infectious and could lead to other serious illnesses. The standard of care upon onset of symptoms is to test for strep to rule out the infection. In the U.S., there are millions of tests performed because all symptoms of strep are similar to most common seasonal viruses. Most of the tests performed are negative for bacterial infection and are still only performed at physician offices. Unfortunately, lack of provider availability, high costs of healthcare with increased copays and deductibles, and inefficient testing with long wait times for appointments and results are leading Americans to avoid trips to the doctor, and as a result they are either getting sicker or self-treating. 

The catalyst for addressing these issues is to bring to market easy-to-use, highly reliable, affordable, and accessible at-home testing solutions that allow for immediate results and give individuals control of their health. Our platform technology, which can be used for other applications, will result in reducing wait time, delivering convenience, facilitating preventative care, and allowing for easy integration to virtual medicine through telehealth.

2. What went into its development? What hardware and software are involved that you can tell us about?

Our North Star, when starting this venture, was to develop a solution that is easy to use, affordable, and accessible. For ease of use, we used saliva for the sample to test with instead of a throat swab. Although saliva has shown to have its set of challenges, we worked in our lab to develop a formulation using an Isothermal amplification method called LAMP to effectively detect the infection in saliva with a formulation that isn’t affected by variations in the mouth from eating and drinking.

The second item was to make this solution affordable so it can be accessible. We wanted to be priced for retail pharmacy, and through extensive research, found the sweet spot is approximately $30. To achieve that price point, we needed to develop a solution that would have simple components and minimal electrical requirements, with results presented in a way that consumers are comfortable reading. To that end, we developed our device that uses a molecular process has results presented on a simple assay strip and that achieves the price target we set out.

The next item was to make the quality of this solution as good or better than the current standard of care. The current standard care is for a physician to swab the throat, which is invasive and uncomfortable, and run an antigen test in the office. The antigen tests are unreliable, with a 60% false negative for strep. As a result, providers capture a second throat swab, which is sent to a lab for culture, but the results can take days to come back. Our technology uses a molecular process with 99% sensitivity and 97% specificity with results presented in 35 minutes. The best part? Patients never have to leave the comfort of the home. 

3. What need did you identify for doing at-home testing for strep throat? Have other trends in remote/home testing help accelerate the process?

When PCR (meaning a point of care molecular test using a PCR machine) became the new gold standard for testing infection, primarily COVID-19, a few solutions came to market that ran molecular processes for home testing. Although these solutions did well during COVID-19, many failed to expand their technology into other illnesses or simplify the equipment needed. As we’ve learned over the last few years, COVID-19, like many other viral infections, often does not necessitate any treatment, so testing is not as vital. Further, the price tags on these PCR solutions were quite high and not priced for retail, so they were not easily accessible. 

What the popularity of antigen tests around this same time showed us is the need for reliable and easy-to-use home testing, especially as people feel the lack of access to physicians. It was well known that at-home antigen tests were less accurate than PCR tests, however this was often patient preference for testing due to the convenience. This told us we needed to focus on an at-home solution that addressed these accurate issues through our platform. 

We developed a solution that uses the same science as pricier PCR tests but have advanced the platform, so it requires less equipment and is more cost effective. We learned a lot about the strengths and weaknesses of these COVID molecular home tests and chose to address the untapped markets that will disrupt the diagnostic space and a create change in a fragmented healthcare system.

4. What is the technological outlook like for strep throat diagnostics? What else can be done? 

When we think about the future of our platform, we are not focused just on strep. The technological outlook is in the platform solution that allows it to test using a number of modalities and for a number of indications. 

Our first use case is the testing of strep and using saliva. The platform that we have developed allows us to for a similar scientific approach for other illnesses as long as the market wants it or needs it. The next indication we are researching in our pipeline is mononucleosis in saliva, and after that, we plan explore testing with other modalities, like urine or blood.

5. What challenges have you faced as a start-up in this space? 

The diagnostic space is a tough space to begin with because the financial upside is not as high as biotech companies in the therapeutic space. In addition to that, diagnostics has a bad reputation because some companies that have attempted to be in the space either failed or were corrupt. Our biggest challenge is to regain the trust of the stakeholders in this ecosystem so we can move the needle towards democratising diagnostics and empowering people to take control of their health.

6. What plans can you tell us about going forward?

At this point, we are working on refining and optimising the technology and the science. Since we have launched our working prototype, we have more clarity on the things we need to work on before we move to developing the product and have created a roadmap for how we can scale. As the founder, I have been bootstrapping since the venture's inception and hoping to find investors to join us in our journey so we can get this ready for market quickly.

7. Anything else that you’d like to add? 

Since I started RT MicroDx, I’ve faced hurdles as a female, first-time biotech founder, however I’ve also built an amazing network of support – both academic, scientific, entrepreneurial, and otherwise. While we’re working to get to that next step, I’m proud of the work we’ve done to create a novel testing method that is anchored in scientific rigor. And I’m thrilled the industry has responded well to this concept. 

My main driver on this journey is access and solving a need that I saw in the global health equity puzzle. While the convenience and cost factor will certainly make an impact in communities across the U.S., it holds the most promise for medically underserved countries. That impact is what I’m most excited about with this platform, and the potential to solve a global access issue while providing lower-cost, quality health resources.