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With FDA Clearance for BV Test, MeMed Targeting Rollout to Hospital Emergency Departments


NEW YORK – Having this week received US Food and Drug Administration 510(k) clearance for its BV test for distinguishing between bacterial and viral infections, diagnostics firm MeMed now plans to begin rolling out the test in the US with an initial focus on hospital emergency departments.

Eran Eden, CEO and cofounder of the Haifa, Israel-based company, said the test could prove particularly impactful in this setting as it is where "some of the most dramatic cases occur … and the health-economic cost of making a mistake, a false positive or false negative, is most pronounced."

MeMed has established an office in Boston to drive commercialization of the test in the US.

The BV test measures the levels of three proteins — TRAIL, IP-10, and CRP — in patient blood to determine if they have a bacterial or viral infection, or if they have a bacterial-viral co-infection. The 510(k) clearance covered the test itself as well as MeMed's point-of-care platform, the Key, that is used to run the assay.

MeMed began offering an ELISA version of the test in 2015 in the EU, Switzerland, and Israel as part of an early access program, and it received CE-IVD marks for the BV test and Key platform last year.

Last year the company also entered a licensing agreement with diagnostics company DiaSorin, giving that firm the right to commercialize the test for use on its Liaison analyzer platform.

Distinguishing between viral and bacterial infections is key to reducing antibiotic overuse and combatting the development of antibiotic resistance. It can also be helpful for physicians trying to determine the cause of fevers without an obvious source or suspected infections whose location in the body is unknown.

Various lab tests and clinical prediction algorithms are available to identify whether an infection is likely viral or bacterial, but MeMed believes the BV test offers better performance than existing tools. In 2018, the company published a study demonstrating that its test (then called ImmunoXpert) outperformed commonly used measures including C-reactive protein, procalcitonin, interleukin-6, human neutrophil lipocalin, white blood cell count, absolute neutrophil count, and clinical prediction tools.

In that study, the test was able to determine whether a patient had a viral or bacterial infection with a specificity of 94.3 percent and a sensitivity of 93.5 percent. According to the company, across multiple external, double-blind, validation studies, the test distinguished between bacterial and non-bacterial infections with 91 percent sensitivity and 94 percent specificity and ruled out bacterial infection with a negative predictive value of 96 percent.

In addition to its performance, MeMed believes the test's broad intended use will help drive uptake, Eden said, noting that the FDA 510(k) clearance covers use of the test in multiple kinds of infections including upper and lower respiratory infections, urinary tract infections, and systemic infections, as well as use in both adults and children. And while emergency departments will be the company's first area of commercial focus, the test is also cleared for use in urgent care centers.

While molecular, infectious disease testing is an area of rapid growth that has been further accelerated by the COVID-19 pandemic, Eden suggested the BV test could help address cases where molecular testing may not be effective — infections that are hard to access with traditional sampling approaches like swabs or fevers of unknown source, for instance.

Another key feature is the test's ability to identify viral-bacterial co-infections. Eden cited an example encountered at Israel's Hillel Yaffe Medical Center through the company's early-access program for the test in which a pediatric patient presenting with a fever of unknown source tested positive via PCR for adenovirus but also received a BV score indicating high likelihood of a bacterial infection. Ultimately, doctors identified an infected abscess on the patient's spinal cord that they removed surgically.

Sergey Motov, professor of emergency medicine at New York City's Maimonides Medical Center and a principal investigator on the clinical trial MeMed used to support its FDA submission, said he envisioned using the test as part of initial evaluations of patients with fever where a doctor is uncertain of the case's severity.

"If I have a patient who has a febrile illness and I'm not sure if it is bacterial or viral, I'll do my usual diagnostic work-up, including some bloodwork, some imaging studies if I need to, even some definitive diagnostic testing to try to identify the agent, but I am definitely also going to use this sort of point-of-care" test.

He said that existing tests have relatively poor diagnostic accuracy and, more importantly, often take too long to return results.

"I can't wait two to three days to get a result," he said. "That's not applicable to me, I work in an emergency room. If I have a patient with a febrile illness, I have no problem ordering this test right from the get-go, right from triage, even though I'll do additional testing."

The BV test returns results in around 15 minutes.

Motov said he hoped to acquire the Key platform and BV test for his department. He noted that while it remained to be seen what level of insurance reimbursement the test would receive, he believed that being able to quickly and accurately rule out bacterial infections would result in savings that would more than cover the costs of testing.

"You are improving your antimicrobial stewardship, you are preventing patients from getting sicker, from coming back, from returning to the ED, from the whole host of complaints that are related to inappropriate antibiotic use," he said. "That will offset, in my opinion, the cost of testing and the device."

Eden said that MeMed planned to price the test "slightly below" the cost of multiplex PCR infectious disease tests.

"We want this to be highly competitive, and we want to make sure this gets broad access," he said. "It's not a $500 test that requires everybody to think twice before they actually order it."

The BV test is currently the only assay available on the Key platform, but MeMed has in the past expressed interest in putting additional tests, both its own and from other companies, on the system.

Eden said the company saw an advantage of starting with a focus on emergency departments as fitting within the diagnosis-related group, or DRG, payment system commonly used in hospitals, in which an overall payment is provided based on factors like diagnosis and length of stay as opposed to a straightforward fee-for-service model. The DRG system is meant to incentivize hospitals to better manage costs, which Eden suggested the MeMed test could do in much the way Motov described.

"You need to show everyone that, first and foremost, you are providing patient benefit, and then for the health economics that, if you look at the blended cost, you are neutral to the system," he said.

He noted, however, that as the company tries to move the test to more decentralized settings like urgent care centers, securing traditional reimbursement will be key.

"The critical thing [is] there is clinical validation and clinical utility, and that is something we started working on a long time ago and have been putting very significant resources into," he said.

MeMed is targeting in its initial rollout to emergency departments nationwide, Eden said. He added that the company planned to leverage its agreement with DiaSorin to place the test in facilities where its Key platform might not be suitable — in particular locations where higher throughput is required. DiaSorin has around 8,300 Liaison analyzer platforms installed worldwide. He said MeMed is working on additional similar partnerships.

In addition to the US, MeMed plans to expand its presence in Israel, where it is currently in "a few dozen" facilities, Eden said. The company is also establishing a commercial presence in Europe with a focus on the UK and France. The US, though, is its main priority at present, he said.