Mexican Company Enters COVID-19 Test Manufacturing RaceBy Miriam Bello | Wed, 10/07/2020 - 17:32
Q: How is Amunet positioning itself as a diagnostic medical devices and testing powerhouse?
A: Amunet was born out of an initiative to deliver remote healthcare. I started a telehealth project and while developing it, I came to understand the importance of diagnostics and tests to prevent things such as heart attacks, which inspired me to create Amunet. Devices and tests that deliver rapid diagnostics are quite new in Mexico but things like pregnancy tests, for example, have been around for decades. We began by developing a blood test that helps prevent heart attack and today, we have an extensive catalog of diagnostic and testing devices.
Our latest success is the development of a test that detects COVID-19, which we began in January because we recognized the magnitude of contagion. This initiative drew a great deal of attention because there are not many companies in Mexico that develop technology. We are mostly dependent on foreign developments. In fact, much of our work at Amunet is to promote and encourage technology development. Often, biological organisms tend to regionalize or tropicalize and foreign solutions will not work on our population. At other times, due to administrative procedures or costs, viable solutions are not available in the country.
Q: Who are the main clients for your diagnostic devices?
A: It varies depending on the type of device. For example, our vaginal PH test is directed to the final consumer, while our COVID-19 test is for professional use. This test will be sold to companies so it can be applied by a medical professional. Our full catalogue can be access on our webpage.
Q: What was the process of developing a COVID-19 test?
A: When developing this test, two components were key: recombinant proteins and monoclonal antibodies. Amunet has been developing both since 2016, meaning that we have the regional knowledge regarding their behavior and how it can work for us.
These tests were challenging to develop due to the nature of the virus, which changes drastically every week, making diagnosis and patient traceability difficult. This drove us to determine the variants of the virus to create a more reliable diagnostic device. Our device is able to detect protein N and S of the SARS CoV-2 to reduce fake positive results to a minimum. Amunet’s test can also detect if the patient had the virus in the past or if it is still active.
When people get the virus, their viral load increases, which is when the body starts to generate antibodies to combat the virus. To date, there are two types of COVID-19 tests: polymerase chain reaction (PCR) tests and serological tests. PCR tests detect if the virus is still active and serological tests determine if the person has had the virus and developed the antibodies to fight it. We offer a serological test that is by nature cheaper than PCR and more reliable, as there is proof that PCR tests have failed before.
Findings on the subject have indicated that testing is key to determining one’s immunity to the virus as some studies suggest that this immunity will only last three months due to the virus’ constant evolution. This also means that when we have a vaccine, it will need to be administered every three months for people to remain free of the virus. Unlike influenza, COVID-19 is not a seasonal virus, which explains the need for constant reinforcement of the vaccine.
We are working on a test panel to complement our first offering, which will help detect vulnerability to other viruses.
Q: What regulatory challenges has the company faced to release its products in a timely fashion?
A: Mexico has rigorous regulations and standards for diagnostic devices, which makes it challenging to access samples when developing a new technology. Moreover, while Mexico has highly qualified professionals, having access to the best material to enable them to do their work is sometimes hard to do. This has pushed us to diversify our supply to avoid barriers.
Right now, for example, Amunet is waiting for COFEPRIS’ approval of our COVID-19 test, while at the same time, the agency is quickly authorizing foreign tests. This is discouraging because we are not new to COFEPRIS. All our diagnostic tests have been authorized and we are a Mexican company that has developed its very own COVID-19 test. Still, we are on the waiting list.
Q: How does Amunet incorporate digital tools and technology into its practice?
A: The company is betting on telehealth and digital tools to deliver healthcare at home. We are working on the deployment of Health Box, alongside the company Botón Médico. The goal of the box is to virtualize medical attention in the most complete and relatable way possible. Depending on the patient’s condition, the Health Box will include tools like an examination chamber, diagnostic devices, or a stethoscope. This will enable the doctor to safely diagnose the patient remotely. We have taken this project to the city of Puebla and it is a great way to deliver healthcare and improve coverage.
Q: What are Amunet’s near-term goals?
A: Amunet already distributes nationally but now that we have developed an accessible COVID-19 test, I am certain that we have the potential to become one of the most important diagnostic and test manufacturers in the country.
First, we made the antibodies detection test and now we have developed antigen detection test in two formats: a rapid test with a 15-minute antigen or virus detection and a PCR test that is performed in two hours and does not require any equipment at all. We believe this kind of detection will become an industry changer.
Amunet manufactures diagnostic medical devices, recombinant proteins and monoclonal antibodies. It also offers low-cost molecular diagnostic services in the city of Puebla