In a major medical innovation, scientists at the Indian Institute of Technology Madras (IIT Madras) have created a novel biosensor platform for the diagnosis of pre-eclampsia (PE) in pregnant women. The newly developed Point-of-Care (PoC) testing solution employs cutting-edge fiber optic sensor technology and is set to be a quicker and more convenient option compared to current diagnostic techniques.

Pre-eclampsia is a severe pregnancy complication that can lead to life-threatening outcomes for both mothers and newborns. Currently, detecting this condition requires time-consuming tests, massive infrastructure, and skilled personnel, making it difficult for women in remote and resource-limited settings to access timely diagnosis and treatment. Seeing the urgent need for a less complicated and more efficient solution, the team led by IIT Madras came up with a platform that centers on the vital ‘3S’ aspects — sensitivity, specificity, and speed. This novel solution is likely to significantly enhance early detection and management of pre-eclampsia, which will eventually lead to lowering maternal and neonatal morbidity and mortality rates.

The research project was a joint effort of several premier institutions. It was initiated by Prof V.V. Raghavendra Sai and Dr Ratan Kumar Chaudhary, the Department of Applied Mechanics and Biomedical Engineering of IIT Madras, and Dr Narayanan Madaboosi from the Department of Biotechnology of IIT Madras. They were assisted by Dr Jitendra Satija of the Centre for Nanobiotechnology at Vellore Institute of Technology, and Dr Balaji Nandagopal and Dr Ramprasad Srinivasan of the Sri Sakthi Amma Institute of Biomedical Research at Sri Narayani Hospital & Research Centre, Vellore.

Describing the technology, Professor Sai said the team has now established the Plasmonic Fiber Optic Absorbance Biosensor (P-FAB) platform for sensing Placental Growth Factor (PlGF), a significant angiogenic blood biomarker for pre-eclampsia. Based on a polymethyl methacrylate (PMMA) based U-bent polymeric optical fiber (POF) sensor probe, the system is able to sense PlGF at very low levels, namely the femtomolar level.

Giving a progress update on the journey to implementation, Dr Madaboosi informed that the technology has progressively gone through multiple phases of validation, namely, analytical, bioanalytical, and clinical testing. He underscored that the innovation has progressed steadily through the Technology Readiness Levels (TRL) and that extensive analysis of patient samples at large volumes in various clinical environments is the way forward. Further prototyping and refining would allow the ultimate transfer of the technology for commercialization in the near- to mid-term future.

Dr Chaudhary pointed out that the P-FAB based POF platform is not only revolutionary for the detection of pre-eclampsia but also has potential applications for the diagnosis of other communicable and non-communicable diseases. The technology is eco-friendly, with no harsh chemicals required, and recyclable materials are used. Its dip-type, rapid, and low-cost nature needs only a small amount of blood (approximately 30 µL), making it easy and user-friendly. These features render it especially ideal for application in remote and resource-limited regions, where conventional diagnostic equipment is usually not practical.

Dr Satija highlighted the flexibility of the P-FAB approach, citing its ability to be extended to testing for diseases such as cancer, tuberculosis, and Alzheimer’s disease. He noted that the disposable POF probes are cheap and simple to produce, yielding diagnostic information within 30 minutes with minimal reagent consumption. Dr Satija reported that the team has worked on P-FAB technology for more than 15 years, and he was hopeful that it could become as much a necessity and as widespread as glucose sensors are now.

Gaining even more importance to the technology, Dr Srinivasan described how this test can identify Placental Growth Factor as early as 11 to 13 weeks of pregnancy, allowing pregnant women to be divided into high-risk and low-risk groups. Early detection of high-risk cases may enable early low-dose aspirin administration, a known treatment to prevent pre-eclampsia. Therefore, the new platform not only facilitates diagnosis but also serves an important role in prevention, resulting in enhanced maternal and neonatal well-being.

The results of this ground-breaking study have been reported in the renowned journal Biosensors and Bioelectronics and are available at https://doi.org/10.1016/j.bios.2024.116312.