Rooted in Johns Hopkins Research, Rapid POC PCR COVID-19 Test Receives CE-IVD Certification for Use in Europe

Johns Hopkins Researchers Developed Point of Care Platform for New Rapid COVID Test
By Molly Bowen

*Disclosure: The Johns Hopkins University has a financial interest in miDiagnostics, which has licensed technologies that were invented at the Johns Hopkins University. This financial interest includes equity in the company and entitlement to royalties. Several Johns Hopkins faculty are inventors of these technologies and have equity and royalty interests in miDiagnostics, including Dr. Stuart Ray, who is a board member of miDiagnostics. These conflicts of interest are being managed by the University in accordance with its conflict-of-interest policies.

May 23, 2022—In a press release issued May 2, Belgium-based point-of-care diagnostics company miDiagnostics announced the launch of its first commercially approved product, which was developed in collaboration with researchers at Johns Hopkins University (JHU). The company received CE-IVD certification for an ultra-fast COVID-19 PCR test that’s now available for use across Europe; it’s anticipated that miDiagnostics will seek FDA approval for use in the US.

New PCR test yields rapid results

While at-home rapid COVID antigen tests produce fast results, they’re less sensitive than PCR tests. Thus, the antigen tests can miss early detection of low-level infection, particularly in people who are not showing symptoms. The gold-standard PCR tests are far more accurate because they amplify genetic material in the virus, allowing for detection of SARS-CoV-2 infection, even in people with a small viral load who don’t have symptoms. Antigen tests provide results in 10-15 minutes, anytime, anywhere, which is why they are often called “point-of-care” or “point-of-need” tests. Expanding access to the more sensitive PCR test has been a challenge because it typically requires sending specimens to a specialized lab and results can take from hours to a few days. This limits the use of PCR as a point-of-care or point-of-need test. Delaying test results can contribute to community spread and delay access to new COVID-19 treatments that need to be started quickly in high-risk patients. With the certification of miDiagnostics’ point-of-care PCR assay, tests can be administered outside of a healthcare setting and deliver more accurate results in the same timeframe as a rapid antigen test.

From laboratory to production line

The path to product certification began with a partnership between Belgium-based nanotechnology research institute imec and Johns Hopkins under the miLab Research Program. Directed by Dr. Robert Bollinger, Raj and Kamla Gupta Professor of Infectious Diseases, and managed by Jane McKenzie-White, the program was run out of the Division of Infectious Diseases and included more than 35 people across ID, Pathology, Biomedical Engineering, and Oncology. The miLab team generated 19 novel IP disclosures and multiple patents to support the development 4 point-of-care diagnostic platforms:

  • Cell-free imaging, led by Dr. Rene Vidal, Herschel L. Seder Professor of Biomedical Engineering, Whiting School of Engineering
  • Nucleic acid detection, led by Dr. William Osburn, Assistant Professor of Medicine, Johns Hopkins School of Medicine
  • Protein detection, led by Dr. Cindy Liu, Adjunct Assistant Professor at Johns Hopkins and now at The George Washington University
  • Biochemical assays, led by Dr. William Clarke, Professor of Pathology, Johns Hopkins School of Medicine; Director of Clinical Toxicology, Johns Hopkins Hospital

miDiagnostics’ certified test was developed directly from the innovations developed by the miLab nucleic acid detection pathway, in partnership with imec nanotechnology experts. The miLAB clinical evaluation activities were led by Dr. Yukari Manabe, Professor of Medicine in the Division of Infectious Diseases, who leads the Center for Innovative Diagnostics. Dr. Stuart Ray, Professor of Medicine, supervised and led the lab activities of the 4 pathways through the Laboratory for Innovative NanoDiagnostics.

Dr. Bollinger praised the work of the team, which began to collaborate with imec in 2013, “The miLab Research Team represented the very best of Johns Hopkins, and this success showcases what’s possible when people from across disciplines work together. The JHU and imec teams worked extremely well together to develop the technical innovations that led to the development of this new test. From the start, we envisioned this project to lead to new diagnostic platforms that could be leveraged for multiple public health and clinical use cases. It is terrific to see that miDiagnostics has leveraged these technologies to create this first successful commercial test and congratulate them on this achievement. Rapid, highly accurate point-of-care diagnostics certainly benefit those of us in Europe and the US, but this novel technology has great potential to benefit people in low- and middle-income countries, where community-based services are often the only way people get access to healthcare.”

Findings from the research leading to this development were published in 2018.

Powell L, Wiederkehr RS, Damascus P, Fauvart M, Buja F, Stakenborg T, Ray SC, Fiorini P, Osburn WO. Rapid and sensitive detection of viral nucleic acids using silicon microchips. Analyst. 2018 May 29;143(11):2596-2603. doi: 10.1039/c8an00552d. PMID: 29741175.