EMPE Diagnostics has established a global production and R&D facility at Genome Valley and has invested about Rs 25 crore
EMPE Diagnostics, a pioneer in the diagnostics of infectious diseases with a special focus on TB, in July 2023, launched its test kit-mfloDx MDR-TB at Telangana Lifesciences office, in Hyderabad.
It was unveiled by Kalvakuntla Taraka Rama Rao, Minister for IT, Industries and Municipal Administration, Government of Telangana and Raghavendra Goud Vaggu, Global CEO, EMPE Diagnostics, in the presence of Jayesh Ranjan, Principal Secretary, Industries and Commerce and Information Technology; Satish Reddy, Chairman, Dr Reddy Labs; and Shakti Nagappan, Director, Lifesciences, Govt of Telangana, among other dignitaries.
The mfloDx MDR-TB is a rapid, accurate, and affordable kit that provides reliable answers about the bacterium and its resistance profile. The multiplex molecular test indicates the presence of Mycobacterium tuberculosis and its genotypic resistance profile by developing a visual signal. Clinicians can get confirmatory results in a qualitative ‘YES’ or ‘NO’ format, within 3 hours. The kit has been recognised by the World Health Organisation (WHO), approved by CDSCO in India and is currently undergoing clinical evaluation in multiple countries and has patents in 19 countries.
Commenting on the launch of the test kit, Rao said, “We have given impetus to the med-tech sector by strategically investing in world-class infrastructure. Now companies are proudly developing and manufacturing innovative medical products in Telangana for Telangana and the world. I’m glad to have launched EMPE Diagnostics’s mfloDx MDR-TB test kit that combines molecular and sensitive lateral flow biosensors, which can detect the presence of TB bacteria and identify antibiotic resistance accurately, in less than 3 hours even at resource-limited clinics. It is a matter of immense pride that it was developed and manufactured in our very own Genome Valley.”
According to Goud, the mfloDx MDR-TB test kit has been designed to detect tuberculosis (TB) and its antibiotic resistance. It includes controls and MDR-TB Rifampicin and Isoniazid and has been approved by Central Drugs Standard Control Organisation (CDSCO).
“Our aim is to provide user-friendly diagnostic tests that deliver conclusive results for TB patients. In high Tuberculosis burden countries, clinicians are often forced to start empirical antibiotic treatment without proper diagnosis, due to very limited or unavailability of user-friendly diagnostic tests that can provide confirmatory results. This often leads to suboptimal therapy with ineffective drugs, which not only fails to cure the patient but also allows the further spread of drug-resistant TB in society and increases the risk of the development of more resistant and refractory forms of TB. Therefore, WHO strongly recommends rapid molecular in first-line diagnostic monitoring for all suspected TB cases globally. At EMPE, we provide such diagnostic test kits for reducing the time required to initiate effective therapy for TB patients already at the initial contact between the patient and the health care facility,” said Goud.
The company has established a global production and R&D facility at Genome Valley and has invested about INR 25 crore. “We’re the first ever company to receive grants from the European Innovation Council and Bill & Melinda Gates Foundation. We currently have a capacity to make 25 million kits and will be expanding to 100 million kits soon. Our mission is to produce the kits in Telangana and supply them to the world. Early and accurate diagnosis is a critical priority for containing the spread of TB,” he further added.
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