A consortium led by the Barcelona-based company has come up with a rapid way of diagnosing sepsis at the point of care.
Loop Diagnostics is developing a new lateral flow platform and plans 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. Results could come as quickly as within two hours, making it easier for emergency room doctors to diagnose and treat the infection.
It costs less for a hospital to treat sepsis upon admission, at about $22,000 per case on average compared to $70,000 for hospital-associated sepsis, according to a 2018 analysis. Detecting sepsis upon admission likely means the patients are in the beginning stages of the illness when it’s easier to reverse.
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 within hours. The test relies on a blood draw, and no additional laboratory work is needed to produce a result.
Several disposable test kits are in development. 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 U.S. is also a target market for the company. “For diagnostics, the U.S. 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 U.S. clinical trials.
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 U.S. 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.”
This story first appeared in our sister publication, 360Dx, which provides in-depth coverage of in vitro diagnostics and the clinical lab market.