Goa-based Molbio Diagnostics has become the first Indian medical devices manufacturer to get Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for Truenat, an innovative point-of-care Real-Time PCR (RT-PCR) testing platform, to detect Nipah virus (NiV).
The approval comes in the wake of Nipah outbreak this week in Kerala's Kozhikode.While one patient died because of the virus, nearly 280 are under isolation or observation.
Prior to the current reported case from Kozhikode, India had reported three NiV outbreaks in the past (Siliguri in 2001 and Nadia in 2007 (West Bengal) and Kozhikode and Malappuram in Kerala in 2018). NiV is an emerging zoonotic infection that causes severe disease in humans. Signs and symptoms range from asymptomatic to acute respiratory infection and fatal encephalitis.
A WHO-approved frontline platform for TB diagnosis and approved by ICMR for TB, COVID-19 and other diseases, Truenat RT-PCR platform is a decentralised molecular diagnostic tool that can test multiple diseases right at the first point of patient contact.
Truenat is already used in management of infectious diseases such as TB, COVID-19, dengue, chikungunya, Hepatitis, HPV, among others, in the country. It is an indigenously made portable, battery-operated, IoT-enabled point of care RT-PCR platform and can test for nearly 30 diseases, and results take less than an hour.
"COVID-19 has brought out the importance of early and accurate testing for better disease management. We at Molbio believe that reliable point-of-care systems are crucial for ensuring universal access to timely testing for infectious diseases, and that is at the heart of our Truenat technology, " said Sriram Natarajan, Director and CEO of Molbio Diagnostics.
The R&D work on Truenat for Nipah virus was first started in 2018, in collaboration with the National Institute of Virology, Pune (ICMR), to enable detection of the virus during outbreak situations.
"The ability to quickly deploy the platform to the point of need and the rapid testing capability makes it a powerful tool in diagnosis and containment of the Nipah virus. This collaboration with NIV allows us to react quickly in times of need during such emergencies," Molbio Diagnostics Director and CTO Dr Chandrasekhar Nair said.
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