NEW YORK (360Dx) – Having just closed a $70 million funding round, Israeli diagnostics firm MeMed is moving toward broad commercialization of its MeMed BV protein test for distinguishing between bacterial and viral infections while completing development of its MeMed Key point-of-care testing device.
The financing round, which MeMed announced last week, was led by new and existing investors including Ping An Global Voyager Fund, Foxconn, and Horizon Ventures and brings the total amount of funding raised by the company to around $125 million, said CEO Eran Eden, who added that the round was "heavily oversubscribed."
The company is also beginning work on other products in its pipeline, including a test specifically aimed at questions around the management of sepsis.
Launched in 2009, MeMed grew out of a research project largely bootstrapped by Eden and his MeMed Cofounder and current Chief Technology Officer Kfir Oved. Since then, the company has focused on development of the MeMed BV test, originally called ImmunoXpert. which measures levels of three proteins – TRAIL, IP-10, and CRP – in patient blood to determine whether they have a viral or bacterial protein, allowing physicians to more quickly and accurately determine whether antibiotics are needed.
MeMed began offering the test in 2015 in the EU, Switzerland, and Israel through an early access program. That program is still ongoing as the company continues to generate evidence supporting the test. To date, it has used the test on around 12,000 patients, and it currently has 10 ongoing clinical studies evaluating the test, with each study enrolling between 500 and 3,000 patients, Eden said.
In a study published earlier this year in the European Journal of Clinical Microbiology & Infectious Disease, the company and its collaborators presented data showing the test could determine whether a patient had a viral or bacterial infection with a specificity of 94.3 percent and a sensitivity of 93.5 percent, which bested the performance of commonly used measures, including C-reactive protein, procalcitonin, interleukin-6, human neutrophil lipocalin, white blood cell count, absolute neutrophil count, and clinical prediction tools.
Eden declined to give a timeline for a broad commercial launch of the test but said that the company is preparing the market by "running some very concrete, very homogeneous clinical studies to try to tackle different segments within the market."
While development of the BV test has been the company's main priority, it has also been working on development of a point-of-care platform for running the test. Eden suggested that that platform, called the MeMed Key, could present significant opportunities for the company beyond the BV test.
MeMed set out to develop the Key platform due to difficulties they ran into measuring one of the BV test markers using existing point-of-care systems. The abundance of the three proteins in the test span nine orders of magnitude, Eden said, "which is pretty challenging, especially as you move from the centralized lab to a decentralized setting."
"That was the motivation for developing the MeMed Key," he said. However, he added, having developed the platform, the company believes it has potential for clinical testing beyond the BV assay.
"We can basically measure any protein in your body, several of them together, with a very high degree of precision," Eden said. "This opens the way .. for us to [put] additional [MeMed] tests on the platform, but also allows for very interesting collaborations, both with startups and larger companies that are looking to migrate [tests] from the laboratory to the outpatient setting."
"The [Key] platform opens many new avenues in completely other applications… and also provides MeMed with a vehicle for developing its next wave of applications," said Oved.
MeMed has not released data yet on the performance of the Key platform, but William Clarke, a professor of pathology at the Johns Hopkins University School of Medicine and an expert in point-of-care technologies, suggested that the company will likely have a number of competitors as it expands its ambitions for the Key platform beyond its initially developed tests.
Clarke, who is not associated with MeMed, said that while he couldn't evaluate the company's platform without seeing data generated using it, other researchers and firms are similarly building POC immunoassay systems that achieve close to the performance of a central lab.
"Anytime you go from a bigger analyzer to a smaller form factor there are trade-offs, so there are some challenges associated with getting to central lab-level performance," he said. "But I would say that in the case of platforms where I have seen data or have gotten my hands on the platforms, they are approaching central lab quality. Absent any proprietary, unpublished information [on the Key platform], I think it fits into the range of where people are headed with these microfluidic immunoassay technologies."
MeMed plans to offer the BV test both on its Key platform and on a variety of other platforms, Oved said.
"The MeMed Key is an enabler that allows measurement of the BV signature in certain clinical settings," he said. "But in other settings, you might find a different platform that would be more suitable to that workflow. And so in that respect, we are platform agnostic."
He added that the company is partnering with a number of researchers and organizations to adapt the BV test to a variety of testing platforms.
"Whether it is a large automated clinical analyzer or smaller platforms, we want to make sure that our [signature] can be measured on these pre-existing devices," he said. "The aim is to reach as many patients as possible using both our internal platform [the Key] and other existing platforms."
Eden cited several lessons the company has learned through its early-access program that he said have informed its commercialization plans moving forward.
In particular, the company has been able to better identify the specific settings and indications where the BV test added the most value, he said. "When you survey the market, you get one answer, but when you actually launch into the market you often find all sorts of intricacies and subtleties that you didn't anticipate."
Thus far, the company has focused its efforts on the EU and Israel, but it has been laying the groundwork for studies supporting a regulatory submission for the BV test and Key platform in the US, Eden said, though he declined to provide additional details.
MeMed also plans to use the proceeds of its recent funding round to move into other indications, starting with sepsis.
"Sepsis is obviously the adjacent market to [that occupied by the BV test]," Eden said. "There, we're looking at more severely ill patients, many of them in the ICU. So it's a different population and much fewer patients, but it's also a critical problem."
He noted that while sepsis is a relatively crowded space with several existing tests for the condition, "there are several different clinical questions that are interesting in sepsis — it isn't just one clinical question."
The company is also working on tests addressing the neonatal population, Eden said. "It turns out that their immune system behaves in a drastically different manner [from pediatric and adult patients], so you can't really use one test to fit them all."
He added that the company's collection of patient samples would be key to developing its test pipeline.
"We have a repository of thousands of samples of patients with acute infections and inflammatory disorders that we've been collecting for the last decade," he said. "There are other problems we are trying to solve and additional products we are developing, and I think that was an important layer" in investor interest in the recent round.