NEW YORK (360Dx) – Israeli biotech firm MeMed continued the commercialization of its ImmunoXpert infectious disease diagnostic with the publication of new validation data and the announcement of plans to launch a point-of-care version of the test next year.
The Immunoxpert test measures the levels of three proteins to determine whether a patient's infection is viral and bacterial, and in a multicenter study of 529 patients published last week in the journal Pediatrics, it performed with sensitivity of 94 percent, specificity of 90 percent, and negative predictive value of 98 percent.
The results follow findings from previous studies of the test, including one published last year in The Lancet Infectious Diseases that found it distinguished between viral and bacterial infectious with a sensitivity of 87.8 percent, specificity of 93 percent, positive predictive value of 62.1 percent, and negative predictive value of 98.3 percent.
In all, MeMed and its collaborators have tested the assay in clinical studies comprising 2,376 patients, and, according to Eran Eden, the firm's cofounder and CEO, it is currently involved in 10 additional clinical trials at sites around the world.
MeMed has also sold more than 10,000 tests to medical centers through its early access program. The test has the CE-IVD mark and the company is marketing it on a limited basis in the European Union, Switzerland, and Israel.
Through this program, the company is beginning to develop an understanding of how clinicians are using the test within existing treatment pathways and to collect data around health economics and clinical utility.
Eden noted that he and his colleagues have observed an initial reluctance, particularly on the part of experienced doctors, to use the test.
"The first ones to adopt are actually the interns," he said. More experienced doctors "would say 'Look, I've been doing this for 30 years. I don't need any extra test to help me do this.'"
For a less experienced physician, on the other hand, who is evaluating a case "at, say, 2 in the morning after having not slept for 48 hours and with no one to back them up, the test can help take down their anxiety and help them treat [patients] better," Eden said.
He noted, as well, that data MeMed has collected on ordering patterns indicates that use increases as the test demonstrated its value, especially in departments where it helped catch what turned out to be serious bacterial infections.
"We might start out with about eight to 10 cases each week in a small [pediatric] department," he said. "But then you have one or two of these more severe cases that it is actually able to catch, and suddenly you see a blip where [usage] goes up to maybe 40, 50, even in some cases 100 [tests] per week."
This data is based on observations in a "small market environment," Eden cautioned, but, he noted, "it does demonstrate the [potential] market."
Next on MeMed's horizon is launch of a rapid point-of-care version of the test. The current test is run as a manual ELISA with a turnaround time of around two hours, but to move into settings like hospital emergency departments and, ultimately, doctors' offices, a faster turnaround time and more streamlined assay is desirable.
Eden said the company aims to have a functional prototype of the POC test that it can share with its collaborators by the end of the year and to launch the test in the second half of 2018.
The platform, he said, will be an "easy to use and disposable" device "where you can basically load the sample into a cartridge, run the test from a touch screen, and within 15 minutes get the final result."
"It's a very user-friendly device design around many different professional and semi-professional end users," he said, adding that the company plans to target hospital emergency departments with the POC test initially, with the ultimate goal of getting it into settings like doctor's offices.
Eden said the company chose to develop its own POC platform for the test both to "control our destiny" and because the low abundance of one of the ImmunoXpert protein markers presented difficulties for existing platforms they looked at.
The platform is able measure proteins reliable at the picogram per mL level, Eden noted, and added that having developed the device, the company plans to use it for POC assays beyond the ImmunoXpert test. He said it is currently working on other tests that will expand the menu available on the device, but declined to provide any specifics.
The company is also looking this year to launch a US-based study to support submission of the test to the US Food & Drug Administration. It is currently working with US regulators to determine the appropriate study design, Eden said.
In addition to the revenues from the tests sold through its early access program, MeMed is funded by a variety of EU and US government grants and private financing. According Eden, the company has raised more than $50 million in funds to date.
Roughly $30 million of that has come from venture capital firms including Social Capital, Western Technology Investment, and Horizon Ventures, he said, while the remaining $20 million has come from government grants and prizes.
In April MeMed announced it received $9.2 million from the US Department of Defense's Defense Threat Reduction Agency, a portion of which Eden said is going toward development of the POC platform. The company is also using the funds to expand its test menu with an eye toward detecting infections earlier, including in presymptomatic stages.