NEW YORK – Israeli infectious disease diagnostics firm MeMed is ramping up commercialization efforts for its MeMed BV diagnostic test and its point-of-care MeMed Key testing platform.
The company said this week that the test and platform received CE-IVD marks, allowing it to begin placing them in health centers across the EU. Additionally, MeMed is in the middle of a clinical study in the US that will support a Food and Drug Administration submission and US launch sometime next year.
The company is also using the Key platform for work testing its existing markers as well as other proteins to see if they could be useful in diagnosing SARS-CoV-2 infections or predicting the course of the disease in infected patients, said Eran Eden, the company's cofounder and CEO.
The BV test measures the levels of three proteins — TRAIL, IP-10, and CRP — in patient blood to determine whether they have a viral or bacterial infection, allowing physicians to more quickly and accurately determine whether antibiotics are needed.
Haifa, Israel-based MeMed began offering an ELISA version of the test in 2015 in the EU, Switzerland, and Israel as part of an early access program aimed in part at generating evidence supporting the test. To date, the company has used the test in more than 15,000 patients and it has demonstrated the ability to distinguish between viral and bacterial infections with sensitivity and specificity above 90 percent.
In 2018, MeMed closed a $70 million financing round intended to fund development of a point-of-care device for running the BV test, which would allow it to be run in facilities like doctors' offices and return results in as little as 15 minutes. With that platform now in hand and CE-IVD marked, the company is now planning a targeted rollout at select sites in Israel and Europe, Eden said.
He said that MeMed will now focus on "building up our manufacturing capacity, making sure the [Key] technology becomes more and more mature post-launch, and then building a commercial organization around it."
Eden said the company would initially focus on placing the test and device in large medical centers that see large numbers of patients for whom the test could be useful and where it could reach key opinion leaders in the field.
From there Eden said the goal was to spread to secondary hospitals and emergency departments and then to outpatient clinics and eventually into physician offices, though moving into the latter setting was "still down the road," he noted.
"We are working with [the initial adopters] collaboratively to build the guidelines, generate the real world evidence, and then after we scale manufacturing we will go into a full-fledged launch," he said.
Meanwhile, MeMed is also laying the groundwork for a US launch, enrolling more than 1,000 patients for a prospective validation study that is ongoing at centers including Johns Hopkins University and Boston Children's Hospital as well as community settings like urgent care facilities.
Eden noted that while the CE-IVD mark allowed the company to place its instrument and test in settings like doctor's offices, to be able to do so in the US would require that the products become CLIA-waived, a designation that Eden said the company did not plan to pursue immediately.
MeMed has also shifted to focus on developing tools for diagnosing SARS-CoV-2 and predicting the course of a patient's infection, using the Key platform to investigate whether the three markers that comprise the BV test along with additional markers might be useful in this regard.
"One of the critical questions [with COVID-19] is who will and who will not deteriorate" due to infection, Eden said, noting that this is a question the company has been exploring in the context of other infectious diseases.
It has identified through this work a number of molecules "that behave radically different in patients who have a severe outcome," he said.
MeMed has started collaborations with around seven clinical centers in the US, Israel, Germany, and Asia and has collected around 1,000 samples from COVID-19 patients that it plans to use to develop a test for predicting how severe a patient's infection will be so that people at high risk of severe cases can be prioritized for treatment.
It has also launched a collaboration with a Dutch medical center sampling hundreds of asymptomatic healthcare workers to see if it can detect markers that indicate that they have become infected even before they become symptomatic.
"It is extremely hard to develop a new platform," Eden said. "But once you have a platform working and you are able to measure a set of proteins, now looking at them in different contexts and applying different algorithms — I wouldn't say it is easy, but it is easier."
He said the company expected in the near future to publish data from its studies of the host immune response to SARS-CoV-2.
MeMed is also looking at running markers beyond the three that make up the BV test on the Key platform, including both existing markers that could be adapted for the point-of-care format, novel markers the company is developing internally, and markers being developed by other companies or researchers.
Regarding the latter category, Eden said the company was particularly interested in biomarkers that, like the BV test, look at host response mechanisms.
"We have been scouting actively [opportunities] to collaborate or acquire potential host response-based diagnostics in other arenas that will complement our offerings," he said, adding that "we are not limiting ourselves to infectious disease, we are not limiting ourselves to inflammatory diseases."