NEWS
Novel diagnostic streamlines Lyme disease testing
A new serology test for Lyme disease shows promise to streamline the testing protocol and to enable the diagnosis of patients in very early stages of the disease. The single-tier test demonstrated over 90% sensitivity in early Lyme disease patients, as described in a new study published by the Journal of Clinical Microbiology, a publication of the American Society for Microbiology. Lyme disease, a tick-transmitted infection that is principally caused by the spirochaete Borrelia burgdorferi in the United States and closely related species in Europe, has
Evident to acquire Pramana
Evident has announced a definitive agreement to acquire Pramana, a leading manufacturer of digital pathology solutions. Pramana’s autonomous whole-slide imaging technologies, combined with Evident’s longstanding leadership in clinical microscopy and superior optics, will expand the available product offering and generate new insights for pathologists, according to the two firms. Founded in 2021 by nference (a leader in multimodal and agentic AI innovation), Pramana is a global healthcare technology company specialising in the development of fully autonomous image scanning systems for pathology settings in hospitals, research facilities, and educational institutions. Pramana’s family of scanners is a modular system of imaging and workflow solutions that is able to process a wide range of specimens using real-time AI algorithms to optimise efficiency, reduce costs, and enhance safety during the scanning process.
“As the worldwide adoption of digital pathology continues to accelerate, our acquisition of Pramana represents a collaborative opportunity to expand our growing digital pathology product offering,” said Wes Pringle, Evident CEO. “Evident prides itself on pioneering new ways of helping the world see the unseen – this acquisition is an example of our commitment to bringing the most advanced solutions to our customers.”
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become the most common vector-borne disease in the United States, with almost half a million cases diagnosed each year according to the US Centers for Disease Control and Prevention (CDC). Currently laboratory testing for Lyme disease has relied on a standard two-step approach recommended by the CDC since 1995, but is only suitable for patients in the later stages of the disease.
The single-tier test described in the newly published study, ‘Hybrid Lyme ELISA’ was developed by Kephera Diagnostics, uses a novel immunoassay principle based
on the finding that antibody molecules in human serum that are elicited by infection with the bacteria that cause Lyme disease can simultaneously bind to two related but not identical antigens. This approach, which has not been used in any previous diagnostic assay for any other infectious disease, makes possible for the first time a combination of sensitivity and specificity in a single test that rivals that of currently approved protocols that require two sequential tests. Furthermore, the sensitivity of this new single-tier test in early-stage patients was found to be over 90%, significantly higher than the sensitivity of either of the currently FDA-approved two-tier testing methods. n Levin AE, Wormser GP, Horn EJ, Karaseva N, Miller D, Kellogg H. A novel single-tier serologic test to diagnose all stages of Lyme disease. J Clin Microbiol. 2025;63(9):e00483 25. doi:10.1128/jcm.00483-25
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