In an interview with PharmaShots, Tej Patel, CEO of Fluxergy shared his views on Fluxergy’s CE Marking and how it will democratize healthcare while creating better clinical outcomes.
- Fluxergy’s One-hour COVID-19 test requires less than 2-3 minutes of hands-on time and provides lab-quality RT-PCR test results within an hour.
- The Fluxergy analyzer is a compact, high-density integration of standard lab testing technologies that incorporates components such as a fluorescence detector and thermal control element for PCR, a colorimetric unit for detecting immunoassays, a potentiometer for testing of small molecules, and an imaging cytometer enabled with proprietary optics and an evolving AI engine for cell counting applications
- The company is open to collaborations and is in discussions with strategic partners.
Tuba: Discuss the CE Marking for Fluxergy’s Multimodal Diagnostic System.
Tej: The CE marking of the multimodal diagnostic system represents a very important milestone in our company life cycle and technology development.
Tuba: How will it democratize healthcare while creating better clinical outcomes?
Tej: The analyzer combines 4 different testing methods: PCR, immunoassays, potentiometry, and imaging cytometry – hence, it has the potential to offer and make accessible many different types of tests at physician offices, urgent care clinics, and retail clinics. Better accessible testing will motivate more people to get tested and take better healthcare measures. Ideally, fewer people will get hospitalized and saving lots of healthcare $$$ in our health system.
Tuba: What are key features for Fluxergy’s One-hour COVID-19 test and, also discuss its working?
Tej: The key features are its automated direct patient sample-to-answer workflow without the need for RNA extraction. It requires less than 2-3 minutes of hands-on time and provides lab-quality RT-PCR test results within an hour.
Tuba: What platforms, technologies, and workflows do we need to be prepared for the next pandemic?
Tej: We will need a combination of vital sign measurement systems for population-wide screening while respecting privacy protection as well as widely distributed, decentralized health testing infrastructures in retail clinics.
Tuba: Why would one prefer Fluxergy’s test over the other PCR test present in the market for COVID-19?
Tej: The market has been flooded during the pandemic with PCR POC systems that perform great PCR but that’s the only thing they can do. That means we are expecting a large fleet of underutilized POC equipment after COVID-19 is over. Our platform is based on a multimodal technology capable of performing PCR, immunoassays, potentiometry, and imaging cytometry with the same instrument. Hence, today’s Fluxergy’s users of the COVID-19 RT-PCR test will be able to use the very same analyzer also for immunoassays and other types of testing as we will be expanding our product portfolio.
Tuba: Why do you consider Fluxergy’s analyzer ideal for all areas of diagnostic testing?
Tej: Fluxergy’s workflows are sample-to-answer formats independently of the type of testing. The main differences for each type of test will be the sample type and volume as well as the FluxergyCard. This will allow provider sites to establish a homogenous fleet of instruments with standardized and simplified training of lab technicians.
Tuba: Can you put some light on the future of multimodal technology?
Tej: The future of the technology will be driven by the clinical needs for specific multimodal test panels as well as to some extent reimbursement conditions. We are currently exploring with clinicians in the US, EU, and the Asia Pacific the unmet clinical needs for better in vitro diagnostics and how to configure corresponding multimodal test panels.
Tuba: What are the different challenges and opportunities in POC testing?
Tej: The main challenges are the test panel configuration and market development. Providers need to be informed and incentivized to use (more) POC testing solutions. The opportunities are tremendous volume uplift potentials as soon as POC makes it systematically into doctor’s offices and retail clinics. It is important not to see POC as a competitor to Central Labs – POC solutions are convenient tools to expand the reach of Central Labs. The Central Labs will always remain, the POC testing will add to the testing volumes. The biggest opportunity is to perform testing on a level that can help to prevent or reducing hospitalizations and help faster recovery.
Tuba: Are you open to collaborations to expand the reach of your products?
Tej: Yes, we are open for collaborations and are also in discussions with strategic partners.
Tuba: How will decentralized POC testing become a key enabler for telemedicine?
Tej: POC testing will help to make telemedicine better actionable and provide providers real-time data for remote decision-making.
Tuba: Share the company’s growth in the last 10 years. Also unveils your upcoming plans for our readers.
Tej: We started in 2013 and mastered since then successfully challenges in technology and manufacturing. In 2020 we have doubled our employee headcount – by end of 2021, we are expecting to have about 100 employees at our Irvine HQ. At present we are driving our geo-expansion with GTM partners in Europe and Asia-Pacific. We will be keeping the COVID-19 products in our portfolio and add a combined RT-PCR/Antibody test for COVID-19 as well as a multiplex respiratory RT-PCR panel (COVID-19, Influenza A/B, RSV) for the upcoming fall. Beyond that, we are developing tests addressing kidney health and chronic inflammation. – In addition, we are also pursuing parallel business opportunities in the equine health and food safety testing market – as the need for POC is beyond human healthcare markets.
Q12. For a total novice, please explain the Fluxergy Analyzer and the work Fluxergy does.
Tej: The Fluxergy analyzer is a compact, high-density integration of standard lab testing technologies in a box as small as a coffee machine. It incorporates components such as a fluorescence detector and thermal control element for PCR, a colorimetric unit for detecting immunoassays, a potentiometer for testing small molecules, and an imaging cytometer enabled with proprietary optics and an evolving AI engine for cell counting applications. We are aiming to be capable of clinical-grade Complete Blood Count (CBC) at the point-of-care within the next 2-3 years, which is the “Holy Grail” of point-of-care testing. The Fluxergy Analyzer – together with the single-use consumables FluxergyCards, has the potential to make various types of health testing accessible and available at decentralized locations such as physician offices, urgent care clinics, and retail clinics. We are working hard on this vision and currently identifying the right strategic and GTM-partners to prepare the market.
Main Image Source: Live Science
Tej Patel is the CEO of Fluxergy and oversees various aspects of Fluxergy’s strategy, marketing, and technical development. He holds a bachelor’s degree in both Aerospace Engineering as well as Applied Mathematics, and a master’s degree in Aerospace Engineering with a specialization in fluid dynamics from the University of California, San Diego.