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India faces dearth of early diagnostics for neuro-inflammatory disorders. The current test methods are a combination of imaging such as MRI/PET-CT, psychological monitoring, clinical interviews, and a few biochemical tests to detect Alzheimer's, dementia and other neurodegenerative diseases, said Venakata Sasidhar Manda, chief scientific officer, AHERF, founder, Urvogelbio.
This is where blood-based neuronal exosome method would be a game-changer and would help neurologists and psychiatrists treat dementia. We are developing a portfolio of diagnostic tests for Alzheimer's, multiple sclerosis, and stroke diagnostic, using neuronal exosome profiling and cell-free DNA. Novel exosomal biotherapeutics are being developed by using mesenchymal stem cells, cord blood, and amniotic fluids, he added.
Our focus is to develop and commercialize biofluids based diagnostics to manage brain pathologies, including neuro-inflammatory and neurodevelopmental disorders. The technology helps to access the cell type from blood, saliva, urine, and other body fluids, without an invasive biopsy or spinal tap. Additionally, we are planning to complement our exosome technology with the imaging platforms, refined with deep learning algorithms, for increased precision, Manda told Pharmabiz.
Currently, exosome companies are developing diagnostics for the brain diseases which are yet to reach the commercialization phase. Also, the technology platform could guide clinical trials for patient stratification, target–drug interaction, end-point guidance and early identification of failures of clinical trials.
The current gold standard testing methods are late, expensive, elaborate in the clinical dementia stage. Our proposed tests would benefit immensely from our biomarker-based diagnostics. They are recommended biomarkers by National Institute on Aging and Alzheimer's Association (NIA-AA). The most important aspect of our testing paradigm is that even gerontologists and general practitioners can prescribe the test, which would reduce the burden on the neurologists, and help them offer quality time for patients, said Manda.
Conventional tests cost Rs. 40,000 – Rs. 60,0000 with a time frame of a week to a month based on patient cooperation and specialists' availability etc. But our blood-based on neuro exosomal technology could cost around Rs. 10,000-15,000. The testing is easy, less invasive, faster turnaround, biomarker-based and feasible to conduct at an early stage of the disease.
The technology platform will be regulated under Drugs and Cosmetics Act. Good Laboratory practices (GLP) sets the quality standards for the test facility and the proficiency of the laboratories is measured National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation, he said.
Options are emerging for easy, non-invasive diagnosis of neuro-pathological diseases. But the development of these diagnostics are capital intensive and need access to patient samples, clinical expertise. Our biggest asset is the incubation at Apollo Hospital Educational and Research Foundation, which gave us the clinical support needed for such ventures. The next phase is the clinical trials, where we would need access to patient samples, regulatory approvals, and logistics support which are typical bottlenecks of medical start-ups. However, this technology platform will bring a sea change for the 411 ongoing clinical trials, said Manda.
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