Diagnostics in the Fight Against Infectious Disease
- Admin Landrich Group
- Dec 23, 2025
- 3 min read
Meningitis and encephalitis are severe infections of the brain and its protective layers. These infections lead to hundreds of thousands of deaths annually. A far greater number of survivors suffer from devastating, long-term neurological disabilities such as hearing loss, seizures, cognitive deficits, and developmental delay.
The people impacted are primarily children, the elderly, and other vulnerable populations in low-income communities. (Meningitis cases primarily happen in sub-Saharan Africa, whereas different types of encephalitis also occur in parts of Asia, Europe, and the Americas with large mosquito and tick-borne populations.)
The World Health Organization has identified the eradication of these infectious diseases as a major public health goal for this century. In the case of meningitis specifically, which primarily impacts children, it could dramatically reduce mortality and increase quality of life in the region with the youngest demographics, expected to be home to a third of the world’s population by the year 2100.
We often think of “precision medicine” in the context of wealthy, industrialized nations with the world’s longest life expectancies. This is where sophisticated drug diagnostic models are increasingly essential to the treatment of chronic, aging-related illnesses such as cancer and neurodegenerative diseases.
However, the combination of rapid, specialized, DNA-driven diagnostics coupled with targeted therapies is also key to fighting lethal pathogens like meningitis and encephalitis that afflict poor countries. The Belgian manufacturer miDX is an example of a leader in this space, creating a molecular assay for HSV-1 & 2, recently approved by the FDA.
The miDX diagnostic helps clinicians solve the critical challenges around time-to-diagnosis and appropriate treatment. Historically, these diseases were often difficult and time-consuming to pinpoint among many potential causes for infection. This often led to delays in verification and resorting to broad-spectrum antibiotics and antivirals.
In contrast, miDX’s PCR assay tests cerebrospinal fluid (CSP) specifically for the herpes simplex virus, which is a major cause of viral encephalitis and meningitis. By eliminating a complex and time-consuming nucleic acid extraction step, this new version of the PCR assay enables a diagnosis within 30 minutes, a small fraction of the time possible with earlier PCR and pre-PCR assays, which often took 4-8 hours or more.
Clinicians can quickly make an informed decision on whether to administer a targeted therapy like Acyclovir or redirect efforts to other potential causes. These tests also support better real-time monitoring to appropriately reduce or discontinue powerful anti-viral therapies to avoid potential side effects like neurotoxicity, a risk when administered in high doses.
Speed and precision are particularly vital in treatment for vulnerable populations who are at risk for these diseases. Globally, half of meningitis patients are under 5 years of age, with the mortality risk highest for infants less than 6 months old. The World Health Organization estimates that among the 2.5 million meningitis cases annually, approximately 10% die from the disease and another 20 percent suffer long-term disabilities. Encephalitis affects 1.5 million people per year, with a lower rate of mortality but significantly higher risk of disability.
Infectious diseases continue to devastate low- and middle-income countries, damaging economic productivity and diminishing the capacity of the young and vulnerable populations. By accelerating the ability to diagnose and treat these conditions, molecular diagnostics can improve the quality of life for millions, supporting their ability to avoid death and disability from these diseases and enhancing human capital that can contribute to our future global society.
Landrich Group recently served as an advisor to miDiagnostics HSV-1&2 CSF Test in clinical design and regulatory strategy for FDA approval. Landrich played a key role in designing and managing the Usability Engineering and Clinical Performance evaluation studies. “Our successful collaboration culminated in product clearance just nine months after submission,” said Vesna Kostanjevecki, VP of Clinical, Assay & Regulatory Affairs at miDiagnositcs.
