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Midge Medical Takes Aim at Mpox on Portable MDx System as it Mulls Targets for Next Tests


NEW YORK – In the wake of the 2022 Mpox outbreak in Europe, Midge Medical aims to deliver a new test that could help combat resurgent infections as well as help the company diversify its commercial products beyond COVID-19.

Berlin, Germany-based Midge hopes to emerge post-pandemic as a global maker of portable molecular tests on its palm-size battery-operated Minoo instrument with the aim of setting up local manufacturing hubs for instruments that could deliver diagnostic testing to homes, hospitals, and regions with limited access to physicians.

The firm obtained CE-IVD marking in September 2022 for point-of-care use of the Minoo system and its test for detection of SARS-CoV-2 in throat swab samples using reverse-transcriptase recombinase polymerase amplification, or RT-RPA, although the platform is currently available only in Germany. It also said in April it had inked a deal with Institut Pasteur de Dakar to provide its rapid molecular diagnostic test for detection of Marburg virus using the Minoo platform.

Citing a resurgence of Mpox cases this spring, including 17 new cases during the first week of May, Midge officials announced last month they had developed an isothermal molecular Mpox test, also for use on the Minoo instrument, in collaboration with researcher Ahmed Abd El Wahed at the University of Leipzig. The firm said the Mpox assay integrated seamlessly with the test instrument and companion app and noted that it is part of a broader effort to expand its commercially available infectious disease test menu.

Manfred Weidmann, head of biochemistry research at Midge, said the Mpox test for the Minoo instrument is an extension of previous work, published in 2019 in Diagnostic Microbiology and Infectious Disease, on its RPA assay that targets a tumor necrosis factor binding protein gene of West African and Congo Basin Mpox clades. That test was developed for use in Mpox-endemic areas without access to real-time PCR testing.

Weidmann said those study results indicate testing on clinical samples delivered results with 95 percent sensitivity and 100 percent specificity compared to real-time PCR, although he said the firm would need to conduct further clinical testing of a commercial version of that test. The authors noted at the time that the test delivered highly accurate results without cold chain-dependent reagents.

Midge is amid a pack of firms that see similar opportunities for delivering test results closer to patients through lightweight, portable testing instruments, running with the likes of Cue Health and Nanomix. Analysts watching this space have noted that whether a firm can pull ahead of the pack depends on their testing menus, technologies, and their ability to fit into healthcare providers' workflows.

Weidmann said the Minoo system, with its target amplification and readout of fluorescent signals, bears similarities to competitors but stands out for its connectivity. The Minoo instrument connects to a user's cell phone via Bluetooth connection, and data from the instrument are processed remotely.

"A colleague of mine has used it in India and I have used it in Africa, and we had incidences of internet breakdown," he said. "But the system just waited until it came back and just passed on the data anyway. In all cases, the data ends up on the back end, ready for analysis."

In those instances, that colleague used the system in Bangladesh to test for Leishmania while Weidmann used it in Senegal to test for Marburg and Dengue viruses.

Stephan Schliack, head of commercial and operations for Midge, said the instrument is easy to use, even potentially by laypeople, and easy to make because it incorporates components common in cell phones, including its batteries, and other device-specific components that can be made in Europe.

Weidmann noted that the company has also adapted the Minoo instrument to run RT-LAMP assays.

Weidmann estimates he developed about 50 isothermal assays for a range of pathogens during the course of his academic career, and Midge draws on that experience to quickly develop new tests. He had been collaborating for two decades with colleagues at the Institut Pasteur de Dakar in Senegal, and those colleagues called on him for help early this year in response to the Marburg outbreak in Equatorial Guinea, which resulted in 12 laboratory-confirmed deaths and 23 deaths among people with suspected infections. The firm began field tests on-site within a month and demonstrated the test provided accurate results, he said.

"In general, the isothermal amplification we use is very close to real-time PCR specificity and sensitivity," he said.

He added a caveat that individual assays may have lower sensitivity or specificity, but the Minoo isothermal amplification tests are intended for first-line use to help healthcare providers manage an outbreak. The SARS-CoV-2 pandemic, he said, illustrated the need for accurate tests that can help clinicians concentrate resources on those who are truly infected and funnel them toward confirmatory testing. Such first-line tests can help break transmission chains, especially those that can be used by laypeople and at least approach the accuracy of PCR.

Schliack said most Minoo users are nurses working at the point-of-care. The instrument costs €500-€600, and tests run €16-€19 each, price points that he expects are profitable for a company that is reimbursed for Mpox or SARS-CoV-2 identification. The firm hopes to eventually secure US Food and Drug Administration 510(k) clearance that would allow over-the-counter sales of its instrument and tests, and Schliack said he hopes regulatory authorities in Europe will follow the FDA's lead in allowing more home-use OTC tests.

Weidmann said that because medical care in the US can be expensive, a home-use Minoo instrument could help people with suspected infections decide whether to see a doctor. In areas of Europe with few general practitioners, he envisions that the device could be used by nurses or laypeople to administer tests and report the results to physicians or public health officials.

However, Weidmann noted that further verification, validation, and licensing of the Mpox test as a commercial assay over the next 12-18 months depends on investor interest and raising enough money to fund its operations and development and regulatory plans. Schliack said the firm has raised about $20 million in private investments so far, and another $3 million would help the firm expand into the US market.

Weidmann said the firm is in talks with Institut Pasteur about other tests that could be used to further expand access in Africa, predicting that Africa's burgeoning middle class would be willing to buy such testing.

"If you pick the right pathogens and the right marketing concept, it would very quickly bring molecular diagnostics to quite a lot of people who would otherwise not have access to it," he said.

Midge has in its pipeline for the US market a multiplex test for sexually transmitted diseases, which Weidmann said likely would include chlamydia, gonorrhea, syphilis, and trichomoniasis. The firm also plans to create multiplex respiratory panels targeted to patients by age group with different combinations of influenza A, respiratory syncytial virus, SARS-CoV-2, and Streptococcal bacteria.

Further down the road, Weidmann sees opportunities to develop tests to meet region-specific needs. In Europe, for example, he said the firm could offer emergency-use tests that could be conducted at hospitals in off hours when laboratory testing is unavailable, such as a test for severe pulmonary syndrome caused by RSV infection in children. In low-income countries, he said, local pharmacies with the Minoo platform could offer tests and multiplex assays for a mix of targets such as arboviruses including dengue, zika, and chikungunya. The firm is also considering whether it has an opportunity to bring its platform to veterinary markets.

"There are so many options which we could choose, but there is not really a decision yet where we would go," he said.