Biomeme’s Rapid Molecular COVID-19 Test

Mr. Perelman described the system as simply as possible. “There are three main pieces to [the system]. There’s the sample prep, the assay, and the thermocycler. The sample prep is what’s used to extract and purify DNA or RNA from a sample and that’s what we’re looking for. The assay or the test reaction is unique to the DNA/RNA signature that we’re looking for so that could be a SARS-CoV-2 test or an influenza test or a series of genetic mutations. The third piece is the thermocycler, which is the hardware controlled via a smartphone app; it’s primary job is to very accurately heat and cool, excite the PCR test reaction with light in specific wavelengths, and then detect the fluorescent readings,” he said. What separates a SARS-CoV-2 test from another diagnostic test using the methodology developed by Biomeme is the programming of the assay portion of the system. In the case of the coronavirus, the assay is designed to recognize two genes: the Open Reading Frame 1ab (Orf1ab) gene and the Spike (S) gene, which gives Covid-19, and all coronaviruses, the distinctive spiky shape.

There are several reasons Biomeme’s system is so beneficial in comparison to the traditional coronavirus testing process. As previously mentioned, the nasal swabs collected at COVID testing sites can be taken and tested at the same location. The entire testing process, monitored via the smartphone interface, takes less than an hour as opposed to the normal route, which can take several days. Each system can run nine samples simultaneously. “You can see the results on the app as well and then when there is a cellular/wifi connection all that data automatically syncs up to our cloud portal so you can remotely manage all the test results coming in in real time. That becomes really cool because you’ve got all these GPS-tagged test results across the world all going up into a central database; you could be doing heat maps of distributions of positives and negatives and where people are being tested,” said Mr. Perelman. In addition, Biomeme’s PCR based test results, supplied by the thermocycler affectionately named the “Franklin” after Rosalind Franklin, are the most sensitive and specific of the current technologies available. “Sensitivity” refers to the number of copies of the signature gene required for the system to recognize the virus’s existence. Equipment that is more sensitive will require fewer copies of the gene. “Specificity” indicates the correctness of the diagnostic result.

The current usage of Biomeme’s COVID test is thanks to the FDA’s emergency use authorization, which we have seen play out in terms of coronavirus vaccines as well. The process of FDA authorization is a lengthy one, but the emergent pandemic situation required fast action. In general, the onset of the pandemic has implemented an aspect of speed in the development and authorization process. “At the beginning of the pandemic—it just accelerated everything in human health and we repurposed a lot of our research-use-only, non-human technologies and capabilities for the pandemic,” commented Mr. Perelman. As of now, despite the relative simplicity of operating Biomeme’s test, the FDA has deemed it “high complexity” and placed it into the category of authorization that only allows the test to be run by CLIA labs approved to run high complexity tests. This move was a safety precaution considering the platform had not been previously FDA approved for other human health tests before the pandemic. Nonetheless, Biomeme has continued to work towards improved testing processes. “We're trying to figure out ways to dramatically scale our ability to test more people because really what’s needed in the country is much more PCR testing so we don’t compromise on sensitivity, but in a way that does not delay results and is also at a cost low enough that we can afford to use it in some of the underutilized areas like K-12 schools,” described Mr. Perelman, emphasizing the need for testing in school populations who will be the last to receive the vaccine.

Masterman Senior, Ryo Lindsey, has been working at Biomeme as an R&D assembly technician since the summer in hopes of gaining exposure to the field. His daily work revolves around manufacturing fluidic cartridges to be used in the research and development of Biomeme’s next gen system. Ryo described how COVID employee screening has been implemented at Biomeme, where employees are swabbed and tested using the Franklin every morning: “Everyday I would come in and get tested before I started working. The test takes like 60 minutes, so I wouldn’t get my results until after I was working, but somebody explained to me that COVID takes time to actually be contagious and we are testing everyone on an ongoing basis. As long as you get the test and you’re negative, then you’re negative [non-infectious] when you’re working.” Ryo emphasized that he had learned a lot in the course of his job and was very appreciative of his position saying, “I'm just happy that I get to work there. It's something that I look forward to now. I'm thankful for Max for giving me the opportunity and I'm excited to continue working there.” In terms of the future, Biomeme will continue on its innovative path and Mr. Perelman stressed the important role PCR technology will continue to play: “We were doing this before the pandemic and we’ll continue to do this after the pandemic. There are so many interesting uses of PCR. I want to get back to just learning about the world and learning about myself. I think one of the few good things that may have happened from this pandemic is people know what PCR is… and now it's just deploying this so that anyone, anywhere can use these capabilities for whatever they may care about.”