Co-Diagnostics’ joint venture, CoSara Diagnostics, has secured clearance from the Central Drugs Standard Control Organization (CDSCO) in India for its SARAQ Hepatitis B (HBV) Viral Load Kit.
The regulatory approval allows CoSara to manufacture and sell the new real-time HBV PCR test as an in vitro diagnostic (IVD) test in the Indian market.
Developed using Co-Diagnostics’ CoPrimer technology, the kit is designed to assess the response to antiviral treatments in HBV patients.
CoSara Diagnostics director Mohal Sarabhai said: “The disease burden of HBV in India was estimated at around 50 million in 2017, and the World Health Organization (WHO) believes the number of chronic HBV infections in South-East Asia to be around 18 million people.
“While no cure for HBV exists, treatment can help to slow damage to the liver and ultimately improve long term survival prospects among infected individuals, provided those treatments are seen to be effective at reducing the patients’ viral loads.
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“Demand for our new SARAQ HBV viral load test has been strong, and we believe that it can play an important role in improving the quality of life of those individuals undergoing treatment for HBV in India and the surrounding regions.”
According to the WHO, HBV is a disease that leads to more than 800,000 deaths a year.
In some areas of the world, the disease is highly endemic, with more than 1.5 million new infections a year and approximately 300 million people with chronic infection.
Earlier, CoSara obtained CDSCO approval for RT-PCR tests designed for the detection of hepatitis B, hepatitis C, Mycobacterium tuberculosis, chikungunya, dengue, malaria, HPV-HR, and HPV types 16 and 18.
Its two Covid-19 assays, a dengue/chikungunya duplex test and a Flu A/Flu B/COVID-19 (ABC) multiplex test also secured regulatory approval.