Co-Diagnostics (NASDAQ:CODX) Inc announced that CoSara Diagnostics Private Ltd, its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization (CDSCO) in India to manufacture and sell its SARAQ Hepatitis B (HBV) Viral Load Kit as an in vitro diagnostic (IVD).
CoSara's new real-time HBV PCR test is built on the company's patented CoPrimer technology and designed to be used as an aid in assessing response to antiviral treatments in patients diagnosed with HBV, a disease that leads to more than 800,000 deaths per year, according to the World Health Organization.
HBV is highly endemic in some areas of the world, with more than 1.5 million new infections each year and roughly 300 million people living with chronic HBV infection, despite the existence of a safe, available and effective vaccine.
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"HBV is a prime example of the persistent toll endemic diseases can take on the populations they afflict, even those diseases which are largely preventable and for which vaccines exist, including what we are now beginning to experience in the current phase of the COVID-19 pandemic,” said Dwight Egan, Co-Diagnostics (NASDAQ:CODX) CEO in a statement.
He added: “The diagnostic markets for HBV and other endemic diseases grow on a yearly basis, which drives our goal of providing affordable, high-quality diagnostic tools for areas affected by them, both through our centralized laboratory products like CoSara's new test, and our expanded focus on at-home and point-of-care offerings."
CoSara director Mohal Sarabhai noted that while no cure for HBV exists, treatment can help to slow damage to the liver.
"The disease burden of HBV in India was estimated at around 50 million in 2017, and the WHO believes the number of chronic HBV infections in South-East Asia to be around 18 million people,” said Sarabhai. “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.”
Sarabhai added: “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."
CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C, HPV types 16 and 18 and HPV-HR, two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex test, and a Flu A/Flu B/COVID-19 (ABC) multiplex test, all designed using the company's patented CoPrimer technology and cleared to be manufactured and sold as IVDs in the Indian market.
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