Fluxergy Inc. is getting government funding that will bring the company one step closer toward commercializing its point-of-care testing platform.
The Irvine-based diagnostics company last month announced that it’s collaborating with the National Institutes of Health (NIH) on developing a screening test panel for sexually transmitted infections (STI).
Receiving this in-kind funding from the NIH serves as validation for the company, according to Chief Executive Tej Patel.
“People see the value in these multimodal technologies that we’ve been creating, so we’re really excited because it’s going to help us continue the development of a lot of the other molecular assays that we’re looking to produce,” Patel told the Business Journal.
This funding makes Fluxergy the first company to participate in the Diagnostics Development Services program within the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
The program aims to accelerate product development of in vitro diagnostics for infectious diseases by providing reagents, platform testing and other preclinical services.
Clinical Trials Set to Start This Year
The goal is to make rapid tests for STIs such as gonorrhea and chlamydia, which typically have to be sent out to a lab, so patients can get their results before they leave the doctor’s office, Patel said.
Under the partnership, NIH-funded contractors will complete research projects on the company’s rapid Fluxergy Analyzer to make molecular tests for fungal pathogens that cause STI’s and bacterial and fungal vaginosis.
The Fluxergy Analyzer, about the size of a small desktop computer, combines different test modalities, including molecular, immunochemistry and hematology, into one system.
It’s advertised as being capable of delivering test results in 30 minutes or less.
Patel said product development has been going well and the company is preparing to start clinical trials sometime this year.
“I think we’re really set up to succeed,” Patel said.
DoD Grant for Sepsis Diagnostics
Earlier last year, Fluxergy also announced a partnership with the Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) through The Henry M. Jackson Foundation for the Advancement of Military Medicine.
Fluxergy and ACESO received an undisclosed grant from the Department of Defense to develop diagnostics for sepsis, a life-threatening condition where the body’s immune system has an extreme response to an infection, causing organ damage and death.
The global estimate of six million sepsis-related deaths per year is thought to be an underestimate due to diagnostics limitations in low and middle-income countries, according to the Pan American Health Organization.
“Rural settings don’t offer point of care testing, not because the information is not valuable but because it’s way too expensive,” Patel said.
A basic metabolic panel, for instance, is reimbursed at around $8.50, but a single cartridge can cost $20.
Patel said that Fluxergy can produce the same metabolic test at a lower price point and sell it to an urgent care for around $5 so it can make a profit or at least break even.
“There’s other companies developing similar multimodal technologies, but when you look at them, they all struggle to meet the cost of goods,” Patel said. “That’s what we’re really trying to address.”
