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Loop Diagnostics Developing Lateral Flow Test Platform for Sepsis

NEW YORK – Loop Diagnostics is developing a new lateral flow platform for diagnosing sepsis at the point of care. A consortium led by the Barcelona-based company recently received €150,000 ($176,000) in EU funding to bring the technology to market and current plans are to have disposable assays commercially available as soon as next year. A reader capable of multiplexing tests and undertaking quantitative measurements of reactions will soon follow.

According to CEO Enrique Hernandez, Loop Diagnostics is positioning its test platform as an alternative to blood culture techniques or competing molecular tests that he claims are not sensitive enough to provide clinicians with the information necessary to make what could be life-saving decisions.

The core concept is to identify bacterial infections by analyzing the biological activity of immune cells using blood-based biomarkers. By providing a relatively quick result in about two hours, the company believes its approach will assist emergency room doctors in making treatment decisions for patients that present with sepsis.

Hernandez said the idea for the company developed out of his participation in d-Health Barcelona, a postgraduate program for innovators and entrepreneurs, where he witnessed first-hand the need for a rapid test for triaging potential sepsis patients.

"We focused on sepsis because it's difficult to get results," he said. "Microbiology tests and growing it in culture take a long time, and they don't have the sensitivity to identify the source of infections," he said. "We decided to create something for the market, so we went to Barcelona and decided to focus on this issue as a company."

The company is currently based out of StartUB!, an incubator at the University of Barcelona.

Loop Diagnostics' approach is centered on identifying the cause of a patient's bloodstream infection by monitoring immune response, as opposed to trying to identify the specific pathogen and then selecting therapies based on that information. Using markers identified together with collaborators at Bellvitge University Hospital in Barcelona, the company claims it can diagnose patients using an in vitro cellular immunoassay it calls SeptiLoop within hours. The test relies on a blood draw, and no additional laboratory work is needed to produce a result. Both Loop Diagnostics and Bellvitge will co-own any IP related to the approach, which is patent pending.

According to Hernandez, Loop Diagnostics has obtained about €280,000 in grants from various institutions in Spain since it was incorporated in February 2018. This month, the company gained an additional €50,000 through the EU Horizon 2020 backed Digi-B-Cube effort, which provides grants for small and medium enterprise-led projects that combine digital technologies with bioimaging, biosensing, and biobanking. Twenty-two projects received funding through the first round of Digi-B-Cube, the final applications for which were accepted in July. The next cut-off date for the second and final submissions is in February 2021.

The total budget for the new project, called SeptiBell, is actually €150,000, as the two partners on the project also received €50,000 a piece for their participation. Raoul Jansen, a Dutch designer, is another partner who is helping to develop an automated multiplex reader for Loop Diagnostics' SeptiLoop tests that the firm calls SeptiBell. ColorSensing, a spinout of the University of Barcelona that has commercialized a method for automatic color recognition, is the other partner. According to Hernandez, ColorSensing's technology will form an integral part of the SeptiBell reader, which the company hopes to see on the market by 2021.

"They will provide color recognition to support different assays," noted Hernandez. "Their software will be inside our reader, and will not just provide marker identification, it will allow us to quantify reactions," he said. "This will be useful for the emergency physician because it will provide information about the primary source of the septic infection."

Hernandez added that Loop Diagnostics will obtain a license to commercialize ColorSensing's technology together with its test platform.

ColorSensing CEO Maria Eugenia Martin said the firm relies on an algorithmic method to digitize colorimetric assays, including lateral flow tests. "We can offer an automatic and digital result of a colorimetric assay just by taking a picture of it, providing traceability," said Martin. "We also can go from a qualitative result to a quantitative one." The company pairs its approach with custom designed quick response codes, which allow it to analyze a sample using cameras, including smartphone cameras. This makes the solution low cost, easy to use, and ubiquitous, not requiring any special equipment," she said.

As part of the SeptiBell consortium, ColorSensing will work with Loop Diagnostics to design a solution to meet their needs, Martin said. "For that, we will have to define the needed steps and perform different kind of validation assays," she added.

There are actually several disposable test kits in development at Loop. One will be able to determine whether or not a patient has a bacterial infection, while another will provide clinicians with the source of infection. Ideally, assays will cost about €50 per test, Hernandez estimated, while the reader will also be low cost in order to support the uptake of the firm's disposables. The manufacturing and supply chain for the disposables and readers is under discussion internally.

Once ready, the company will apply for grants to support clinical trials of its platform in Europe, Hernandez noted, but the US is also a target market for the company. "For diagnostics, the US is a very attractive market," he noted. Loop Diagnostics is currently taking part in an accelerator program called Health Wildcatters based in Dallas-Fort Worth in Texas. While its participation is now virtual, due to the ongoing COVID-19 pandemic, the company is considering establishing a subsidiary in Texas to attract investors and lead US clinical trials.

"The idea of the accelerator is to explore the US market, and it provides contacts to attract investment," said Hernandez. "We are thinking of creating a subsidiary to move this forward."

Multiple companies are working to fill the need for rapid and more accurate tests for sepsis with a variety of technologies. Boxborough, Massachusetts-based startup HelixBlind is currently developing a point-of-care test for bloodstream infections that runs on single-use disposable cassettes. ImmunExpress, meantime, is already launching a real-time PCR test for sepsis in Europe ahead of a planned US debut. PixCell Medical, an Israeli company, is also developing a sepsis test that relies on its imaging flow cytometry technology.

Hernandez acknowledged that there are multiple competitors developing tests, as well as those with assays on the market, but noted that the diagnostic windows for these tests can vary, while others rely on several biomarkers using molecular platforms, an approach which he said can complicate results for clinicians.

"Our competitive advantage is that our diagnostic window starts an hour after the initial bloodstream infection," he said. "This allows the early diagnosis of sepsis."