NEW YORK – The COVID-19 pandemic has shed light on the need for mass testing, particularly in areas that don't have access to centralized laboratories or trained technicians.
One company taking aim at this problem is startup Fluxergy, which began with the goal to provide mass advanced laboratory-quality testing with a portable, low-cost instrument that could improve accessibility in low- and middle-income countries. But now the firm also is eyeing a potential future for its testing platform in the home, enabling the collection and analysis of more data through multimodal testing, said CEO and Cofounder Tej Patel.
Many other diagnostic developers focus on one type of test per instrument, such as PCR-based tests or ELISA tests, but Patel emphasized that doctors often aren't only looking at only one kind of test to get a view of a patient's health status, but rather are looking at a variety of testing parameters to more fully understand the patient. The Irvine, California-based company's multimodal analyzer reflects that reality, taking a "360-degree view of the patient" using one microfluidic cartridge that can run multiples kinds of tests including PCR, immunochemistry, and cytometry, Patel said.
The technology for the assays run on the Fluxergy analyzer is standard and well-known, Patel said. Using a microfluidic cartridge, which is based on technology similar to the print circuit board industry, the company's instrument takes "typical macro-scale laboratory testing you do where you manipulate fluids with pipettes" and compacts them down, dealing with smaller volumes of fluid, he said. The fluid manipulation system on the cartridge works "just like any other microfluidic cartridges … in regards to fluid manipulation where you use pressure and different types of manipulation methods to move fluid around and to do these different types of chemical reactions," he said.
For the molecular tests on the instrument, for example, all of the reagents are on the cartridge, and it has the capability to run the necessary cooling and heating cycles for a PCR test, Patel said. "We basically can kind of put all of the key parts of an assay onto this cartridge … [which] is powered and controlled by our analyzer," he continued. The analyzer uses electrical contacts to run and power electronics or move fluids in and out of the cartridge and manipulate them to go into different reaction chambers and perform different steps like mixing, Patel said.
The system also handles sample preparation, including DNA extraction, by using a sample type-specific buffer system. The inhibition-resistant buffer, along with a mixture of surfactants and dispersants, allows for "rapid sample dispersion and lysis of raw sample matrix," according to a study published in the Canadian Veterinary Journal using the Fluxergy analyzer and an assay for Streptococcus equi.
There are a variety of options for how to use the cartridge and analyzer, Patel noted. A user could run two or more different tests at the same time on the same cartridge or one kind of test on one cartridge, offering "massive flexibility," he said. The turnaround time for a test is a little under an hour, with one or two minutes of hands-on time to prepare the sample. The company is also developing capabilities to multiplex 12 targets with both the molecular modality and immunochemistry modality.
David Smith, the head of the Division of Infectious Diseases and Global Public Health and a professor in the Department of Medicine at the University of California San Diego, said his lab uses Fluxergy's analyzer on a regular basis for its PCR capabilities. The benefits of the analyzer are that it's "fast and simple to use," and there are very few barriers to using it, he said. He's recommended it to other labs and healthcare providers, and noted it is priced "better" than most other platforms.
He also noted that the platform's data system keeps information "all in one place and easily accessible and interpretable."
There's are other microfluidics-based POC analyzers on the market or in development, such as one by British molecular diagnostics firm QuantuMDx, which is also intended to be used in low- and middle-income countries, but the device only performs PCR testing. Scope Fluidics, Meridian Bioscience, and UK firm DnaNudge also have microfluidics-based instruments for use at the point of care.
But Patel said that as far as he knows, Fluxergy is the only company bringing an expansive multimodal platform to the point of care. In 2019, Roche took over a prototype of a multimodal diagnostic POC platform from BioMed X, but it could take many years to come to market. Qiagen has its QiaStat-Dx instrument that can run PCR tests at the point of care and has an immunoassay reader built in, but it does not currently have an immunochemistry test for the system and it doesn't include cell-based cytometry capabilities.
Currently Fluxergy is finishing up CE marking for its Fluxergy CoVID-19 Sample-to-Answer-RT-PCR test and the analyzer. The cost for the SARS-CoV-2 assay in the European Union is $50, Patel said, but the company intends to bring the price down. The analyzer, meanwhile, costs between $5,000 and $8,000.
The company is also developing a multimodal SARS-CoV-2 assay with two tests, one a molecular PCR test operating on a nasopharyngeal sample and the other a blood-based IgG antibody test, both of which can be loaded onto the same cartridge. "You can actually run two totally different tests on the same cartridge at the same time," he said.
Fluxergy is targeting a manufacturing capacity for its COVID-19 test kits of 100,000 tests per month, but the goal is to eventually scale up to one million tests per month based on demand, Patel said. With the manufacturing facility the company has set up for its tests, it is particularly easy to switch the kind of test being manufactured, he added. "It's really a modular system with all the automation that we've put into it that lets us … very quickly switch out the tooling to be able to manufacture" a new product, he said.
Although there's no published data yet for the SARS-CoV-2 test, Patel said it was "very comparable to other point-of-care COVID tests" in performance.
In the molecular sphere, Fluxergy wants to add more testing for infectious diseases, including a respiratory panel that would include influenza and respiratory syncytial virus, a panel for women's health infectious diseases, and tests for bloodborne pathogens. More routine tests also are in the works, such as metabolic panels and complete blood count tests, and those "routine common lab tests will be of a lot of value to us," Patel said.
He emphasized that the analyzer and tests are meant to be easy to use for people who haven't been trained in a laboratory, and the device has multiple safeguards to ensure the sample collection and testing are correct, such as the cartridge only fitting in the machine one way and only a certain amount of sample able to be inserted into the cartridge. "When you design the platform, you design it to make sure it's easy and straightforward to use," Patel said.
There are also automated quality checks to verify the appropriate volume of reagents are being used, the cartridge has no issues, and the device is working correctly, he added.
The analyzer also is designed to be easily integrated into an electronic medical record in doctors' offices and clinics and can be used in clinical labs for quick testing, such as for COVID-19 before a patient goes in for an operation.
With the eventual goal of moving to at-home testing, Patel said ultimately there should be minimal barriers to testing and having enough data to understand how your body is performing. "It's really hard to say how you're doing from one data point every year" from an annual laboratory test, he said.
"Having a platform that can do those common lab tests quickly and at the point of care has a lot of value," Patel said.