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Fraunhofer, Mologic Partner on Microfluidic Test for UTI Diagnosis, Antibiotic Resistance

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NEW YORK (GenomeWeb) – Fraunhofer UK Research and Mologic are developing a new microfluidics-based test to not only identify if bacteria causing urinary tract infections (UTIs) are present, but to gauge their resistance to different antibiotic treatments.

NHS England recently awarded the project roughly £900,000 ($1.3 million) following an initial investment of £92,000 in April 2017. According to project organizers, feasibility testing in the first phase of the project was successful and clinical trials are planned for later this year.

NHS England made the funding available through its SBRI Healthcare initiative, under which it awarded £8.7 million to 10 projects in February. Each of the projects is focused on new technologies that could improve primary care and general practitioner services.

NHS England had made initial investments into 22 companies last year, and Fraunhofer UK Research and Mologic's project met the initiative's benchmarks for achieving additional funding. The program has invested £75 million into 150 companies since it commenced in 2009 and it holds two competitions for funding each year.

Simon Andrews, executive director at Glasgow-based Fraunhofer UK, said that Fraunhofer and Mologic are developing a point-of-care device capable of performing "immediate bacterial infection diagnosis and antibiotic susceptibility testing" on urine samples within a GP setting.

"The device will be able to detect relevant levels of bacteria if present in the urine sample and provide information regarding their sensitivity or resistance to the antibiotics most commonly used in UTIs," said Andrews. "It will tell the doctor, is there an infection and if so, what is the right drug to treat it effectively."

Fraunhofer, a Munich, Germany-based research organization, established Fraunhofer UK Research in 2012. At the same time, it established the Fraunhofer Center for Applied Photonics (CAP) at the University of Strathclyde in Glasgow, which specializes in laser and light sources.

According to Andrews, the idea for the new project originated in Fraunhofer CAP. It's based on the concept of combining silicon photonic waveguides and microfluidics to "get very precise and rapid results."

Fraunhofer had not previously worked with Bedford, UK-based Mologic. Since it was founded in 2003, Mologic has delivered a variety of assays for infectious disease testing to market. For instance, it sells BVPro, a point-of-care test for bacterial vaginosis that detects sialidase enzyme activity in vaginal swabs using a lateral flow immunoassay system. It attained a CE-IVD mark for the test in March 2017. The company also sells Periplex, another CE-IVD marked lateral flow immunoassay, for confirmation of peritoneal dialysis, enabling preemptive use of antibiotics.

"This product fits with our existing portfolio and strategy to develop point-of-care tests to improve use of antibiotics," CEO Mark Davis said. "By combining our expertise in developing and commercialising IVDs with Fraunhofer's research and technology experience, we have a real opportunity to better target treatments and avoid the inappropriate use of antibiotics."

According to Davis, Mologic will be responsible for commercializing the resulting product, and clinical trials for the prototype it will commence this autumn. He did not provide a timeline for when it might hit market. The company believes demand exists for such a test as between 1 percent and 3 percent of all GP consultations in the UK are UTI-related, and practitioners currently rely on a battery of dipstick tests for nitrites and leukocytes,, as well as culture for antibiotic sensitivity testing as required.

"Antibiotic prescribing is done on an uninformed basis, as the prescription is generally written at the time the patient presents, rather than waiting for laboratory results," Davis said. "Often there is pressure from patients to receive a prescription regardless of whether they actually have a genuine infection," he said. "All of these points are relevant with the growing concerns about antimicrobial resistance, driving demand for a test which can provide antibiotic sensitivity information at point of care."

Fraunhofer and Mologic are not the only parties contributing to the effort. In addition to input from the University of Strathclyde relative to microbiology and access to organisms, the partners have also enlisted the help of Barclay Medical Practice, a group of GPs located across Scotland, to supply end-user feedback and assistance with any studies.

Another participant is Wideblue, a Glaswegian industrial design firm that specializes in the manufacture of optical systems and medical devices. According to the partners, Wideblue will work closely with Mologic and Fraunhofer to develop the actual device, as well as to ensure it meets regulatory standards, based on Fraunhofer's prototype.

Kelvin Nanotechnology, meantime, will provide the microfluidic chips for the planned device. The company, also based in Glasgow, offers fabrication services based on electron beam lithography. Founded in 2000, the firm claims on its site that it processes 1,000 wafers per year in its 1,350-square-meter nanofabrication facility, the James Watt Nanofabrication Center. Using its lithographic approach, it will etch the microfluidic device at the heart of Fraunhofer and Mologic's new test. The firm also has experience in fabricating chips for photonics applications.

Andrews said that the chip component of the test will consist of silicon photonics for optical interrogation combined with a polymeric microfluidic structure. "The urine sample flows through the microfluidic, and the … mechanism is interrogated by the light passing through the silicon photonic part," he said.

Andrews noted that Fraunhofer and Kelvin Nanotechnology have worked together on other projects in the past. "The microfabrication expertise from KNT is vital to providing routes to low cost per test which will be integral to the NHS and to successful commercialization," he said.

Andrews reiterated that by enlisting the help of Wideblue and Kelvin, the partners gained the "perfect combination of expertise and professional organizations" to realize their aims.

"From the biologic and photonic science inputs, to the electromechanical engineering, it's all being done in a context with partners guiding towards a successful outcome because of the early input and direction of end users and [in vitro diagnostics] medical device regulators and manufacturers," he said.

Once available, Mologic's test will compete in a market that includes a number of offerings aimed at UTIs and antibiotic resistance. Gaithersburg, Maryland-based OpGen last month launched a research only, real-time PCR panel that detects the most common bacterial causes of UTIs, as well as 47 antibiotic resistance-linked gene targets.

Closer to Fraunhofer and Mologic is Linear Diagnostics, a Birmingham, UK-based firm that announced in September that it is developing a microfluidics-based test for bacterial infections and antibiotic resistance, with UTIs as an initial indication.

Innovation in the area also continues. In October, researchers from the California Institute of Technology described a new digital nucleic acid amplification method for rapid antibiotic susceptibility testing.