NEW YORK (GenomeWeb) – Israeli biotech firm MeMed is embarking on a series of new clinical studies and platform development efforts as it aims to expand the reach of its ImmunoXpert test, a proteomic tool for guiding the use of antibiotics.
The company said this week that it has won a €2.3 million ($2.6 million) grant from the European Commission to support clinical testing of the panel. It plans to use the funds to support a 1,200-patient study in pediatric departments in one German and one Italian hospital, monitoring children with either respiratory tract infections or fevers without source and assessing both the clinical utility and cost-effectiveness of the test.
The study is one of several ongoing for ImmunoXpert, Eran Eden, MeMed's co-founder and CEO, told GenomeWeb this week. Additionally, the company is working to adapt the test to several different formats, making it suitable for use in settings ranging from hospital emergency departments to doctor's offices.
Launched in 2009, MeMed grew out of a research project by Eden and his MeMed Co-founder and current Chief Technology Officer Kfir Oved. ImmunoXpert is the company's lead product. The test measures levels of three protein biomarkers to determine whether a patient's infection is viral or bacterial.
MeMed aims with the test to address problems of antibiotic overuse and the subsequent development of bacterial antibiotic resistance. Unlike bacterial infections, viral infections are not typically susceptible to antibiotics, but because it can be difficult to quickly tell the difference between the two, antibiotics are often prescribed to treat viral infections.
Underuse is also a problem in some settings, as growing concern regarding antibiotic overuse may cause physicians to delay treatment in cases they are unsure are bacterial infections.
Last year, MeMed published in PLOS One data from a 1,002-subject clinical study in which its three-protein signature distinguished between bacterial and viral infections with sensitivity of 93 percent and specificity of 92 percent. Since then, the company has gathered additional data both through an early-access program launched last year and a variety of ongoing clinical studies.
The company's early-access program offers the test, which has the CE IVD mark, on a limited basis in the EU, Switzerland, and Israel. MeMed has tested more than 5,000 patients through this program to date, Eden said, noting that this number was growing rapidly. He added that the performance of the test in this setting has been comparable to that observed in the PLOS One study.
The company also has ongoing studies looking at 600 children with respiratory infections; another looking at 800 children with respiratory infections and fever without source; and a multisite prospective trial being run by several outside collaborators. It also has studies ongoing in elderly patient populations, which is the other initial target for the test.
Each of these studies is another piece of the puzzle," Eden said. "If you really want to convince the clinical community and yourself, you have to go through multiple clinical studies."
While this is true for any diagnostic, ImmunoXpert's case is further complicated by the differences in antibiotic use across the various geographies where the company hopes to sell the test, as well as the different settings in which it plans to implement it.
"For example, in Nordic countries you have a relatively lower rate of overuse but then a higher rate of underuse compared to France or Israel where you have a relatively higher rate of antibiotic overuse," Eden said. "And that obviously will affect the underlying health economics and clinical utility."
"We need several clinical studies, several different countries, several different health systems, to build a really holistic health economic and clinical utility picture," he said.
Additionally, these factors will shift depending on the setting where the test is being used, Oved noted.
"The health economics and clinical utility can dramatically change between, for example, an emergency department and the outpatient setting," he said. The ideal format for the test will also change depending on the setting, and MeMed is working to adapt the test to a variety of platforms.
Currently, the company offers the test as a manual ELISA with a turnaround time of roughly two hours. It will use a portion of the funds from the recently announced EC grant to transfer this ELISA to an automated format on a Tecan EVO 75 robotics platform, which will reduce the manpower required for running the test but will leave things like turnaround time and sampling requirements essentially the same.
That version of the test is suitable for standard hospital use, Eden noted. To get the test into emergency departments, however, the company needs to bring turnaround time down to around 30 minutes, and to do this it is looking at automated immunoassay formats such as those offered by various large IVD companies.
Even more demanding is the doctor's office setting, where, Oved said, a turnaround time of 15 minutes or less is required, as well as an instrument capable of using samples collected from a finger prick as opposed to conventional phlebotomy. Additionally, any such instrument would need to be extremely reliable while also essentially maintenance free, requiring infrequent QA and calibration.
"There's a pretty high bar when it comes to a product that could have real success in the outpatient setting," Oved said.
According to Eden, MeMed is working both internally and with outside collaborators to develop such a platform for the ImmunoXpert test.
The company has thus far concentrated its efforts in the EU and Israel, but it views the US as a key market, Eden said, adding that it has begun doing some "initial work setting up collaborations with key opinion leaders" and plans to start a dialogue with the US Food and Drug Administration in the near future.
In addition to the award announced this week, MeMed has won previous EU awards totaling €9 million. The company has also been through several funding rounds, though Eden declined to name participants or say how much it has raised.
MeMed currently has 30 employees, up from 19 a year ago.