NEW DELHI: ‘Make in India’ diagnostic tools for early detection of critical diseases such as Alzheimer’s, cancer and gastrointestinal disorders were launched on Tuesday.
The Drugs Controller General of India (DCGI) has already permitted the use of these indigenous in-vitro biomarkers, which were officially launched on Tuesday and will be manufactured in Kochi, Kerala.
It will be available in all laboratories by the end of the month.
“This pioneering collaboration under the ‘Make in India’ Initiative introduces advanced biomarkers for early disease detection. It is a groundbreaking development in India’s healthcare sector with the introduction of Chemiluminescent Enzyme Immunoassay (CLEIA) technology,” said John Thomas, Managing Director of Agape Diagnostics Ltd., a leading In-Vitro Diagnostics (IVD) company that delivers high-quality diagnostic solutions across the healthcare spectrum.
“This advancement, part of the ‘Make in India’ initiative, marks a significant milestone in the indigenous manufacturing of cutting-edge diagnostic tools, specifically designed for early detection of critical diseases such as Alzheimer’s, cancer and gastrointestinal disorders,” he added.
For these biomarkers, Agappe collaborated with Fujirebio Holdings Inc., Japan, a global leader in in-vitro diagnostics (IVD) specializing in the development and commercialization of innovative diagnostic solutions.
Bhaskar Mallady, CEO of Agappe Diagnostics, said, “The efficacy of these biomarkers would depend on the type of disease one is dealing with. For neuro biomarkers for Alzheimer’s, the efficacy would be to help identify the patients very early so that doctors could devise ways to treat those patients.”
“In the case of biomarkers, which are into cancer, a doctor can screen and diagnose and monitor the progress. Thus making a huge impact in improving and saving the lives of the people who have cancer. These biomarkers will impact the diagnosis and therapy model overall,” he said in this paper.
He said Alzheimer’s patients have to go through MRI and CT scans for diagnosis traditionally, but with these biomarkers, doctors can quickly identify the disease.
Bhaskar said there are six million Alzheimer’s patients in India who have been identified and diagnosed.
“Globally, there are 60 million Alzheimer’s patients. When we do proper screening in India, we will also find that these numbers will go up to double digits,” he added.
At the launch of the biomarkers, Takashi Ariyoshi, Minister and Deputy Chief of Mission at the Japanese Embassy in India, said there is a long tradition of Indo-Japanese collaboration. “Biomarkers are today an essential tool for early diagnosis of Alzheimer’s, liver cancer and gastrointestinal diseases.”
In a statement, the company said the partnership between Agappe and Fujirebio Holdings is a testament to the benefits of the “Make in India” initiative and a significant stride towards reducing dependency on imports.
“By localizing the production of advanced diagnostic tools, Agappe is paving the way for substantial cost savings and fostering self-reliance in critical healthcare technologies,” the statement said.
CLEIA, an evolution of the widely recognized Chemiluminescent Immunoassay (CLIA), combines the sensitivity of chemiluminescence detection with the specificity of enzyme immunoassays.
This potent combination enables the precise detection of low concentrations of biomarkers, making it indispensable for early diagnosis, which is crucial for effective treatment outcomes.
In modern In-Vitro Diagnostics (IVD), CLEIA plays a pivotal role in screening, early detection, disease progression monitoring, and guiding personalized treatments, particularly in oncology, where early detection of cancer markers can significantly improve patient survival rates, a statement from the company said. “This represents a monumental step forward in advancing immunoassay technology in India,” it added.
