MIT Spinout Creates Rapid COVID-19 Diagnostic Test

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The world is in the midst of a COVID-19 pandemic as countries are taking bold measures to slow the spread of the SARS-CoV-2 coronavirus.

Testing for COVID-19 is critical to combat the public health threat. On March 12, 2020, the Massachusetts Institute of Technology (MIT) announced that its spinout startup, Cambridge based E25Bio, is preparing to submit to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization a cost-effective COVID-19 test that can deliver rapid results in less than 30 minutes.

Having access to accurate testing with a quick turnaround time can help slow the spread of COVID-19 and enable earlier medical intervention and treatment. Without scientific testing, there is no way of knowing exactly how many people have the COVID-19 disease—public health decisions become based on estimates, opinions, and best guesses rather than on verifiable quantified data.

Testing helps prevent those who are infected from fueling the outbreak and potentially spreading the SARS-CoV-2 coronavirus to family, friends, and throughout the community. Isolating the infected from the healthy can help to prevent further spread of COVID-19. Before COVID-19 was declared a pandemic by the World Health Organization (WHO), the reported numbers of cases in the United States was relatively low. However, the actual number of those stricken with COVID-19 in the U.S. may be orders of magnitude higher because accurate testing has not been widely available.

The potential advantages of E25Bio’s COVID-19 test are that its paper test strip is low-cost, scalable, and easy to produce in mass quantities, and the testing process itself is rapid—results are produced in 20 minutes.

E25Bio’s COVID-19 test is based on lateral flow technology created at MIT’s Institute for Medical Engineering and Science (IMES) by Professor Lee Gehrke, scientist Irene Bosch, and their research colleagues. The scientists have created similar diagnostic tests based on lateral flow technology for infectious diseases such as dengue fever, Zika, and Ebola.

In September 2017, the researchers published in Science Translational Medicine their method for creating rapid antigen tests for dengue virus serotypes and Zika virus in patient serum that can be useful in creating rapid diagnostics for other pathogens. Specifically, the researchers created antigen-based rapid tests that use monoclonal antibody (mAb) pairs to detect and distinguish the four dengue virus serotypes, as well as Zika virus, without cross-reactivity for greater precision.

The concept of the test is a bit similar to how pregnancy tests work, only for COVID-19, the indicators form based on the presence of the viral proteins. Pregnancy tests are designed to detect human chorionic gonadotropin (hCG) hormone that is produced by the human placenta when an embryo attaches to the uterus. The way pregnancy tests work is when a solution (urine) is applied on a test strip that is coated with monoclonal antibodies: If there is hCG in the sample, the monoclonal antibodies will bind with the hCG and change the color indicator. Monoclonal antibodies are lab-synthesized molecules engineered to bind to antigens, the harmful substance that triggers the body’s defense system via an immune response to produce antibodies. Examples of antigens include viruses, fungi, and bacteria that cause diseases and infection.

For detecting the SARS-CoV-2 coronavirus that causes COVID-19, test strips of paper coated with antibodies that bind to a targeted viral protein are dipped into a solution that consists of a patient sample with gold nanoparticles attached to a second antibody. If the patient sample contains the viral protein, those proteins will bind to the antibodies on the nanoparticle-bound antibodies and the ones on the paper strip, forming a colored indicator on the strip in 20 minutes.

Pending FDA approval, the next step for E25Bio is to conduct trials with patient samples. If the diagnostic tests with patient samples are successful, the startup biotech plans to use it for clinical diagnosis to help fight the global COVID-19 pandemic.

Copyright © 2020 Cami Rosso All rights reserved.