Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge.

The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform. “The fully automated, direct patient sample-to-answer test has a simple workflow and does not require any RNA extraction,” Tej Patel, Fluxergy’s CEO, told BioWorld, noting test results can be communicated “cybersecurely” to laboratory information systems at provider sites.

The Fluxergy system comprises the Fluxergy Card, a single-used, lab-on-a-chip consumable test cartridge, the Fluxergy Analyzer, which performs the testing, and Fluxergy Works software for reviewing and interpreting the data. The test cartridge is multimodal and designed to be cost-effective and scalable.

Multimodal advantage

The multimodal capability allows users to run distinctive point-of-care panels with the potential to do built-in reflex testing, among other options, according to the company. Potential targets for rapid testing include emergency rooms, outpatient and urgent care settings, workplaces and school reopenings.

“The actual power of the AI-based system will become most evident with the introduction of the imaging cytometry tool in about two years. Until then, elements of our software system, enhanced by advanced algorithms such as machine learning, will be used to support data collection from multimodal tests such as combined PCR/antibody tests for … COVID-19,” Patel said.

“The multimodality itself will increase the attractiveness of point-of-care tests in the PCP [primary care provider] or other patient-near provider sites such as retail clinics. Having various test types – ranging from PCR to cytometry – in one instrument will simplify the management of testing equipment.”

The ultimate goal, Patel said, is to have CLIA-waived point-of-care systems in retail settings and potentially in consumer’s homes.

Initial rollout

The Irvine, Calif.-based diagnostics startup is currently identifying partners to help bring the product to different regions within the EU and to select countries in Asia Pacific and the Middle East where the CE mark is accepted.

“We have received first orders from European countries,” Ali Tinazli, Fluxergy’s chief commercial officer, told BioWorld, adding that demand will be driven by pandemic waves and changing regulations in countries the company is targeting.

“As more people are getting mandatory tests, the overall testing demand for PCR testing will go up as well and remain at a stable plateau for the next few years,” he said. “COVID-19 is expected to be an endemic disease for the next five to 10 years.”

Fluxergy received $30 million in funding in 2020 from John Tu, principal investor and Kingston Technology Corp. co-founder and CFO of Fluxergy, to rapidly scale production of the Fluxergy Analyzer in response to the coronavirus pandemic. Last summer, the company invested in a new research and manufacturing facility with more than 20,000 square feet of production space,. With the additional capacity, Fluxergy is now capable of producing up to 1 million systems per month.

U.S. plans

Prior to CE marking, the platform has been available on a research-use-only basis at the University of California San Diego and Mass General Brigham hospital in Boston. The install base of about 20 analyzers is being used for clinical research.

Fluxergy has filed a request for emergency use authorization from the U.S. FDA, which, if granted, would permit medical sites with CLIA-certified high complexity laboratories to use the Fluxergy system as a COVID-19 diagnostic tool. The company also is working to validate its system for a possible future EUA request for use as a point-of-care COVID-19 test.

The company is also looking to submit a 510(k) for permanent U.S. FDA clearance “as soon as possible,” Patel said, with the planned commercial launch of a multiplex respiratory PCR panel in 2022.

In December, Fluxergy received dual ISO-13485-2016 and Medical Device Single Audit Program certifications.