DCGI approves Molbio Diagnostics Nipah virus test kit Truenat
New Delhi: In a significant development, the Drug Controller General of India (DCGI) has granted emergency use authorisation to Truenat, a real-time Polymerase Chain Reaction (PCR) platform manufactured by Goa-based Molbio Diagnostics, for testing people infected with the deadly Nipah virus.
With this approval, Molbio Diagnostic's Truenat test kit for Nipah virus has become the first kit in India to receive regulatory approval to conduct tests for Nipah.
The decision came just days after a 12-year-old kid in Kerala's Kozhikode district died from Nipah virus infection.
Nipah virus (NiV) is a zoonotic virus which is transmitted from animals to humans and can also be transmitted through contaminated food or directly between people. In infected people, it causes a range of illnesses, from asymptomatic (subclinical) infection to acute respiratory illness and fatal encephalitis. The virus can also cause severe disease in animals such as pigs, resulting in significant economic losses for farmers.
Prior to the current reported case from Kozhikode, India has reported three NiV outbreaks in the past-- Siliguri in 2001 and Nadia in 2007 (West Bengal) and Kozhikode and Malappuram in Kerala in 2018.
Unfortunately, no medications or vaccines are now available for Nipah virus infection, despite the fact that WHO has designated Nipah as a priority disease for the WHO Research and Development Blueprint.
PTI reports that Molbio Diagnostics on Wednesday said its platform Truenat has received emergency use authorisation from DCGI for Nipah virus testing. Testing for Nipah virus can now be performed rapidly on Truenat, a real-time PCR platform, on demand, the Goa-based firm stated.
This will result in early and fast diagnosis for effective management of the disease and containment of the spread of Nipah virus, it added.
Truenat, which is a battery-operated and IoT-enabled point of care RT-PCR platform, can test for nearly 30 diseases, and results take less than an hour.
Truenat is already playing a critical role in the management of infectious diseases such as TB, COVID-19, dengue, chikungunya, hepatitis, HPV, etc. in the country.
It is also approved by the World Health Organisation for tuberculosis diagnosis and approved by the ICMR for tuberculosis, COVID-19 and other diseases.
"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," Molbio Diagnostics CEO Sriram Natarajan stated.
Truenat is the first platform to be authorised by the Drugs Controller General of India (DCGI) for Nipah virus testing, he added.
The R&D work on the Truenat test for Nipah virus was first started in 2018 in collaboration with the National Institute of Virology, Pune (ICMR) to enable the detection of the infectious virus during outbreak situations, the company said.
The ability to quickly deploy the platform to the point of need and the rapid testing capability make it a powerful tool in diagnosis and containment of the spread of Nipah virus, it added.
Further, Molbio Diagnostics Director and CTO, Dr Chandrasekhar Nair, said in the statement as quoted by IANS, "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 such emergencies."