One of the most effective ways of limiting the viral transmission of COVID-19 is through contact tracing, which requires a lot of diagnostic testing. During the last 12 months, many companies have had to pivot from their traditional business areas to embrace new ways of doing business.
One such company is Fluxergy, a California-based company that has been developing rapid testing technology that can undertake polymerase chain reaction (PCR), chemistry, immunochemistry and cytometry-based testing all at the same time. This technology is designed to be used at the point of contact—where the testing is taking place—negating the time taken for sending samples to specialist labs.
The technology has largely been used in equine veterinary applications before the beginning of 2020 to test for inflammation in horses and to ensure that their endocrine systems are producing the correct hormones at the right levels. But when the pandemic began to spread across the globe, Fluxergy saw an opportunity to use its knowledge in equine testing to create a clinically approved test for COVID-19 that would deliver results in just one hour.
Fluxergy’s cofounder, Tej Patel, who has a master’s degree in aerospace engineering from the University of California, San Diego, explained: “COVID-19 has challenged a lot of what we do here at Fluxergy. When the pandemic broke out, we knew that our platform could be a valuable tool to help combat the spread of the virus. As soon as we realized that this would be a huge problem around the globe, we started developing a molecular PCR-based SARS-CoV-2 assay that could detect the virus in under an hour at the point of care.”
One of the biggest challenges that Fluxergy had to overcome was the rapid development cycle of a COVID-19 assay—the qualitative assessment or quantitative measurement of the presence, amount or functional activity of a target entity—in this case, the SARS-CoV-2 virus.
Patel said, “Trying to develop an assay in such a compressed time frame meant that we had to be able to iterate very quickly with new changes or improvements and design modifications all having to be done as quickly as possible.”
Fluxergy has used SOLIDWORKS Premium and Professional, along with SOLIDWORKS PDM, for the design and development of its products, as well as to support their manufacturing and later life cycle improvements.
Another challenge that Fluxergy faced in its pivot to COVID-19 testing was manufacturing scale up.
“Right now, testing is a major bottleneck in understanding the spread of the SARS-CoV-2 virus,” Patel explained. “One of our major focuses was on how we take our current existing manufacturing capacity—which is around 10,000 kits a month—and scale that up to 100,000 with the capability of going to a million test kits per month.
“That was a huge feat and required a significant amount of engineering resources from all of our team members. We invested massively in automation equipment, as well as focusing on designing and developing our own automation equipment in house that was capable of producing test kits from raw materials all the way to final packaging.”
People who use clinical diagnostic platforms require reliable and accurate results. Because of that, one area of major focus and challenge that medical device manufacturers must address is the quality system. Patel said that Fluxergy spent a significant amount of time and effort developing a fully-fledged quality system that could manage all the design, development and manufacturing processes from start to finish.
“This scale-up process also included completing our ISO 13485 and MDSAP [Medical Device Single Audit Program] certifications required for medical device manufacturers. Our new production facility is approximately 27,000 square feet and gives Fluxergy a state-of-the-art microfluidics fabrication capability as well as formulation and other key production capabilities needed for producing medical diagnostics devices.”
Patel added, “One of our major focuses when the pandemic started was how to document and manage the entire design and development process in addition to our manufacturing processes, which is a key aspect of any medical device. We were able to utilize SOLIDWORKS to help support all of the documentation management and control that we needed to implement to be able to show and explain why we designed and developed our product the way we did.”
Fluxergy has also scaled up its team, which has doubled in size from 40 to 80 employees. “As we grew the team, we had to be able to collaborate,” continued Patel. “Tools like SOLIDWORKS PDM were critical to getting our new team members up to speed quickly on why we design things the way they are designed, how we manufacture them, and how we continue to develop and improve them.
“SOLIDWORKS PDM allowed us to explain all of that information to all of our new team members rapidly so we weren’t wasting time trying to explain where to find equipment, parts or information. This was key for us to ensure that we can develop our products in a very quick and tight time frame.”
The Fluxergy Analyzer is a highly integrated, portable sensor system that uses sophisticated analysis algorithms. It has an active cooling system that allows it to rapidly manipulate the subjected sample to significantly decrease test times. Once closed, its integrated loading port (ILP) becomes fully self-contained, negating any sample contamination.
The sample is inserted on the Fluxergy Card, a disposable test cartridge designed specifically for each type of laboratory test that holds a biological sample from the patient. Once inserted into the Analyzer, it is flooded with a biochemical reagent solution that makes many copies of genetic material from the virus while at the same time testing for antibodies. After about an hour, there are enough copies (or lack thereof) that Fluxergy’s software can detect whether or not the virus is present.
The Fluxergy Card utilizes an aerospace-grade sample targeting system that allows for multiplexing up to six test targets and tests using various modalities such as PCR, chemistry, immunochemistry and more.
“The beauty of multimodality is the potential wealth of information provided to a health care provider, an amount of information typically reserved for 3 or 4 tests from different lab platforms,” explained Patel. “Our multimodal technology has the potential to consolidate a majority of critical lab tests to a single platform.”
Fluxergy Works is the companion software for the Analyzer and can be used on any PC, Mac or tablet, controlling multiple devices and running multiple tests simultaneously.
In late March 2021, Fluxergy announced that it had obtained CE marking for its one-hour COVID-19 RT-PCR test to be used by health care professionals as an in vitro diagnostic (IVD) for the detection of SARS-CoV-2. The CE mark will allow Fluxergy’s testing platform to enter the European Union market and any other markets that accept CE marking as valid regulatory approval.
Fluxergy’s Chief Commercial Officer Ali Tinazli said, “Fluxergy is seeking commercial partnerships with healthcare providers and potential international go-to-market partners in Europe, Asia, and Australia.”