NEW YORK (GenomeWeb) – Irvine, California-based startup FluxErgy is developing a portable microfluidic diagnostics system that it hopes will ultimately be used in physician offices as well as in low-resource settings around the world.
Originally developed with HIV viral load testing in mind, the system is capable of conducting 20-minute real-time PCR tests from a finger prick of blood. However, the company is also adding other assay modalities, including immunochemistry and cytology, with the hopes of building a low-cost system that can perform different types of testing.
Founders Tej Patel and Ryan Revilla originally met at the University of California, San Diego, where they studied aerospace engineering. They then moved on to jobs at a tech company called MagCanica. There, "both Ryan and I worked on a variety of sensor systems for military-related projects in the US Air Force and Navy," Patel said.
But they aspired to entrepreneurship, and in 2013 founded FluxErgy. "We wanted to apply our systems and sensors engineering knowledge to something that can help make this world better," Patel said. The pair also continued gaining knowhow in fluid dynamics and micro-electro-mechanical systems to achieve this goal.
"That is when we started to realize the huge improvements that could be made in the biomedical device industry by applying a systems-level engineering approach to reduce costs and improve efficiency," Patel said.
FluxErgy's platform, the Search Light, was designed to be small, portable, and robust, he said, particularly with low-resource settings in mind. The enabling technology is automated fluid manipulation via microfluidics, which allows for small sample sizes, fast PCR cycling times, and the application of different kinds of assays to the same test cartridge.
"We kind of took a higher, systems-level engineering approach to design the device, and one of the things we built into the system is flexibility — we actually designed it so that we could take already existing assays and optimize them to run on this device in an automated, quick fashion," Patel said.
The system is currently developed for real-time PCR assays, and designed to be "quick and easy to implement a new assay, if someone wants to develop a test for Zika or West Nile, for example," he said.
The company has reduced costs by using scalable manufacturing processes. The commercial systems are projected to be priced at around $5,000 per device, with a minimal cost to manufacture and with cartridges potentially available to low-resource settings in the $5 range.
"We use a lot of existing technologies from other industries, like computer manufacturing, and a lot of our technology [development] went into how we can manufacture and produce these test cards for a very low cost," Patel said.
FluxErgy has launched an access program for potential users interested in porting assays onto the platform or in building other kinds of tests, like chemistry assays.
For PCR, "we don't want to reinvent the assays themselves," Patel said, adding that the group performs a few minor optimization steps to adapt existing assays to the system. "The idea is that PCR is the gold standard ... we don't want to reinvent the PCR assay as much as make a system that can efficiently conduct a PCR assay, or an immunochemistry or cytometry assay."
The company is in the process of publishing studies it conducted with academic partners that describe its HIV viral load assays, Patel said.
Since it started with a staff of five — founders Patel, Revilla, CFO Jonathan Tu, and two biologists — FluxErgy has expanded to 12 employees and is looking to grow even further. Ample private financing has enabled the core team to focus on engineering instead of fundraising, Patel said.
In the long term, Patel envisions FluxErgy's platform being used in sub-Saharan places like Lesotho and Malawi, but also in physician offices in the US. It will focus on research use for the time being, and is considering assays in the applied market of mosquito surveillance. The company is also pursuing ways to use the platform to automate and standardize testing in pharmaceutical trials, with the potential of having the "ready-to-go system" approved by the FDA as a companion diagnostic. But the ultimate goal is to manufacture diagnostic tests to improve patient care. The company is interested in forging partnerships with pharma companies, but also with clinical reference labs who seek automation of small volume testing.
The near-patient and point-of-care spaces are currently being populated by the likes of the Roche Liat, Alere i, and Cepheid Omni, but FluxErgy sees an advantage in the ability to run multiple kinds of diagnostic assays beyond just PCR on the same system.
"In the future, a doctor's office doesn't want to have one machine for Strep A testing and another of CBC testing," Patel said. The cost for low-resource settings will also be a differentiator, he said. "We have a system that is at a completely different price point."