NEW YORK — With a new US Food and Drug Administration clearance for its infectious disease test, Israeli diagnostics firm MeMed is looking to move into more decentralized settings like urgent care centers and, ultimately, pharmacies and doctors' offices.
The company said on Wednesday that it has received FDA 510(k) clearance for the use of its MeMed BV test on whole-blood samples using its point-of-care MeMed Key analyzer. The BV test is intended as a tool to help clinicians more quickly distinguish between viral and bacterial infections.
A version of the test using serum samples received FDA clearance in 2021. According to MeMed CEO Eran Eden, the ability to run the test in whole blood significantly simplifies the sample preparation required for the assay, bringing its run time down from around an hour to 15 minutes and making it accessible at facilities that may not have the infrastructure required to process and run plasma samples.
"This opens up new market segments that otherwise are harder to penetrate," Eden said. "For instance, urgent care centers, which is really a growing segment [within healthcare] where the issue of whether [an infection] is bacterial or viral and [whether it] should or should not be treated with antibiotics, is one of the most routine questions that appears many times a day."
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. MeMed first rolled out an ELISA version of the test in 2015, offering it in the EU, Switzerland, and Israel as part of an early access program. It received CE-IVD marks for the BV plasma test and Key analyzer in 2020.
MeMed has been pursuing a dual approach to commercializing the BV test, developing it for use on the Key analyzer while also entering agreements with larger in vitro diagnostic firms to put versions of the test on their platforms, allowing the company to penetrate large, centralized clinical labs.
In 2020, MeMed entered a licensing agreement with diagnostics firm DiaSorin, giving that company the right to commercialize the test for use on its Liaison analyzer. DiaSorin received 510(k) clearance for that version of the test last year. In May, MeMed expanded the agreement to give DiaSorin rights to sell the test in the Italian market.
At the beginning of 2023, MeMed entered an agreement with Beckman Coulter Diagnostics under which the Danaher subsidiary will develop and commercialize a version of the BV test for use on its Access line of immunoassay analyzers.
With the recent FDA clearance of the BV test in whole blood, "you can now start to think of a hub and spoke model," Eden said. "You use that more robust, high-volume heavy machinery [from DiaSorin and Beckman Coulter] to treat patients whose samples are going to a central lab, but now you have spokes where [you can test] in a more decentralized setting whether it is in a satellite hospital or other more remote setting."
He added that the company plans to develop a CLIA-waived version of the Key platform and BV test that could be used in settings like pharmacies and doctor's offices. Currently, the platform and test are categorized under CLIA as having moderate complexity.
Eden noted that there are several hurdles to developing a CLIA-waived version of the test. The company would likely need to further reduce the test's sample volume requirements, which currently stand at 0.15 mL. Additionally, it would need to demonstrate that the results generated from venous blood samples are equivalent to those from the capillary samples that are typically used in a CLIA-waived setting. That, Eden said, would likely require additional clinical studies.
Eden said that MeMed had not yet received regulatory approval in the EU for the whole-blood version of the test. He noted that while in the past it was common for diagnostic companies to launch in Europe first under the CE mark and then pursue FDA clearance and a US launch, the EU In Vitro Diagnostics Regulation put in place last year was incentivizing more companies to go to market in the US first. He said the company is working to obtain approvals for the assay in the EU and Israel.
Eden declined to say how many BV tests per year MeMed was selling but said that the company "was seeing some very positive momentum" both in terms of the number of sites that had adopted the test and usage of the test by clinicians at those sites.
He said that MeMed recently signed a deal with Israeli health maintenance organization Maccabi Healthcare Services to put the platform and test in all its urgent care centers. Houston-based Nutex Health said in May that it would begin offering the BV test in its 19 hospitals.
Eden projected that a medium-sized urgent care might run around 1,000 BV tests per year, while a large medical center might run several thousand.
DiaSorin CEO Carlo Rosa said during the company's Q3 2022 earnings call in October that it is targeting a set of roughly 100 hospitals in the US where DiaSorin analyzers are installed, "going through an education program whereby we clearly explain the value of this product within the diagnostic algorithm."
MeMed has received coverage of the BV test at a rate of $260.50 per test from the US Centers for Medicare and Medicaid Services (CMS), which Rosa said on the Q3 call was in the "higher range" of what DiaSorin had expected.
On DiaSorin's Q4 2022 earnings call, Rosa suggested that MeMed's recently inked licensing agreement with Beckman Coulter would help further drive sales of the test, noting that as a small company, MeMed has a limited ability to do the physician education necessary to drive uptake.
"There is a heavy lift when it comes to education, and the more players that come to this market, I believe the better it is going to be for the different players," he said.
Rosa noted that another challenge the two companies will face is dealing with the bundled payments insurers commonly use in hospital contracts, in which a hospital is paid one overall fee for, for instance, treating a patient who is admitted due to symptoms of an infectious disease.
"What MeMed has to achieve now is that they unbundle from this some money … to pay for the assay itself," Rosa said. "And this will require time."
Rosa said DiaSorin and MeMed are planning a clinical study of the BV test to generate evidence to support private payor coverage.
Eden highlighted several other recent efforts, both by MeMed and independent researchers, that have provided data supporting the BV test.
In June, researchers from the company and several Israeli medical centers published a study in Clinical Microbiology and Infection in which they used the test in 415 adults admitted to hospital emergency departments with fever. They found that the test detected bacterial infections with a sensitivity of 98 percent, specificity of 88 percent, and negative predictive value of 99 percent.
Also in June, researchers from Texas Children's Hospital and Baylor College of Medicine published a study in Clinica Chimica Acta looking at the test's performance in a retrospective cohort of 60 children who had come to the emergency department with fever. They found that it identified bacterial infections or co-infections with a sensitivity of 94 percent and a specificity of 88 percent, and that it outperformed existing measures like white blood cell counts, procalcitonin, and C-reactive protein.
In May, a team from Maccabi Healthcare Services and Tel Aviv University published a study in Biomedicines looking at the impact of the BV test on antibiotic use at three urgent care centers. Out of 152 patients, physicians were uncertain whether to prescribe antibiotics for 38 of them. In 30 of those cases, they acted in accordance with the BV test results. Additionally, of 39 patients who doctors initially planned to treat with antibiotics, 22 received a BV result indicating a viral infection. Among those patients, antibiotic use was reduced by 41 percent.
Driving adoption of a novel technology "is a lot about proving the clinical evidence," Eden said. "There are really no shortcuts to providing the comfort and confidence that drive adoption."