NEW YORK (360Dx) – With a recent €50,000 ($62,000) Phase I grant from the EU's Horizon 2020 SME Instrumentation program, Swedish microfluidics firm Gradientech plans to explore the potential US market for its QuickMIC antibiotic susceptibility testing system.
Further, said CEO and Cofounder Sara Thorslund, the Phase I award makes the company eligible to receive a Phase II SME Instrumentation award, which totals between €500,000 and €2.5 million.
According to the Horizon 2020 website, the SME Instrumentation program is intended to support "close-to-market activities" with the focus being on instruments with the "potential for high growth and internationalization."
Gradientech is developing the QuickMIC system as an in vitro diagnostic for AST in sepsis patients, and Thorslund said it aims to secure a CE-IVD mark for the system by the spring of 2019.
The QuickMIC system uses Gradientech's microfluidics technology to establish a series of antibiotic gradients in which clinicians can grow their samples of interest to gauge their susceptibility to these drugs. According to Thorslund, the system generates antibiotic susceptibility data in two hours, significantly faster than the 24 or more hours typically required by the culture-based methods commonly used in clinical AST work.
"With microfluidics we can very rapidly create a very stable gradient of antibiotics to our sample, and then we can continuously image the bacteria to see how they grow and to calculate the growth difference [across different antibiotics] over time," she said. "And because of the gradient, we get so much information from a single sample that we [can use] very short test times."
Thorslund said sepsis is a particularly good target for the system due to the need for rapid AST results to help doctors develop a treatment plan for this often fast-moving condition.
Gradientech was founded in 2009 as a spinout from Uppsala University and began to develop the QuickMIC system around 2012, Thorslund said. It also offers microfluidic-based cell-based assays on its CellDirector research platform.
Thorslund declined to say how much the QuickMIC system would cost, but said that she expected that its relatively low price and modular design would help drive adoption.
"These are small, cost-effective instruments, which will make it easy for labs to get started," she said, noting that this would enable labs to try out the system while maintaining their existing AST systems.
"You can start out small and then add modules depending on your needs," she said.
The company is now in the process of setting up production of the system. "During the last year, much of the development [of the system] has been done, and now we are setting up production with our manufacturing partners," Thorslund said. "That's where we have a lot of focus now."
After setting up production, the next step will be doing the clinical validation trials necessary to secure a CE mark and, down the road, US Food & Drug Administration clearance.
Thorslund said that while Gradientech is familiar with the European AST testing market, it is less familiar with the US market. The company will use the Horizon 2020 funds to learn more about the landscape of the US clinical business.
"I think the workflows and such are very much the same in the US [as in Europe], but the pricing could look a bit different and we don't have the same reimbursement system as in the US," she said. "As a European company we need to understand that a bit better."
Rapid AST assays are a growing business with a number of firms developing such methods. Thorslund identified Tucson, Arizona-based Accelerate Diagnostics as perhaps its leading competitor. Last year, the US FDA cleared Accelerate's Pheno AST system, which the company said can provide AST data in seven hours.
Other firms targeting the rapid AST market include Affinity Biosensors, which is developing a rapid AST system called LifeScale that the company said can deliver results in 3.5 hours; and Roche, which is developing AST assays on its Geneweave platform.