CoSara Diagnostics gains CDSCO approval for Saragene COVID-19 2-gene multiplex RT-PCR test

CoSara Diagnostics, a prominent player in the field of molecular diagnostics, has achieved a significant milestone with the Indian Central Drugs Standard Control Organization (CDSCO) granting approval for its Saragene COVID-19 2-gene multiplex RT-PCR test. This regulatory clearance marks a pivotal step in expanding the availability of high-quality, affordable COVID-19 diagnostic tools in India, specifically tailored to meet the demands of the ongoing pandemic.

What Does the CDSCO Approval Mean for CoSara Diagnostics?

The CDSCO’s approval for the Saragene COVID-19 2-gene multiplex RT-PCR test signifies its acceptance as an in vitro diagnostic (IVD) for the qualitative detection of the SARS-CoV-2 virus, responsible for COVID-19. This approval is vital as India continues to battle COVID-19, aiming to keep the positivity rate under 5%, a goal supported by the Indian government’s push for more accessible RT-PCR tests.

Mohal Sarabhai, Director of CoSara Diagnostics, emphasized the significance of this approval in the company’s efforts to contribute to India’s COVID-19 response. He referenced the Indian Prime Minister’s endorsement of an increase in the availability of RT-PCR tests and expressed CoSara’s commitment to offering affordable, high-quality diagnostic solutions nationwide. The Saragene test, manufactured in India, aims to meet the needs of both domestic and international markets, ensuring broader access to accurate testing.

Key Features of the Saragene COVID-19 Test

The Saragene COVID-19 test is designed using Co-Diagnostics’ proprietary CoPrimer technology, which also powers the Logix Smart SARS-CoV-2 multiplex test. This advanced technology is crucial for ensuring precise and reliable detection of the virus, offering significant advantages in multiplex capabilities compared to other diagnostic platforms.

The Saragene test focuses on two key gene markers in the SARS-CoV-2 genome: RdRp and E-gene. These markers are pivotal in the virus’s detection, as they help identify the presence of the virus with high specificity. This multi-target approach is essential for accurately diagnosing COVID-19, especially in regions where regulatory bodies recommend using tests that can target multiple genetic markers of the virus.

Co-Diagnostics’ Role in the Fight Against COVID-19

CoSara Diagnostics is a joint venture between the American molecular diagnostics company Co-Diagnostics and India-based Ambalal Sarabhai Enterprises. The approval of the Saragene test underscores the company’s ability to leverage cutting-edge technology in responding to the global healthcare crisis.

Dwight Egan, CEO of Co-Diagnostics, highlighted the superiority of tests developed using the CoPrimer technology. He noted that these tests offer enhanced multiplexing capabilities, which can be pivotal in accurately identifying the virus. The highly specific nature of the Saragene test, which aligns with guidance from the World Health Organization (WHO), further strengthens CoSara’s position as an active participant in combating the COVID-19 pandemic.

Egan’s statement suggests that CoSara Diagnostics is poised to play an even more prominent role in the global effort to manage and control COVID-19, especially as governments and health authorities continue to emphasize the importance of reliable, multi-target diagnostic solutions.

The Path Forward for CoSara Diagnostics

With the CDSCO approval now in place, CoSara Diagnostics is ready to expand the availability of its Saragene COVID-19 2-gene multiplex RT-PCR test throughout India. The company’s focus on providing high-quality, “Made in India” diagnostic solutions positions it as a key player in the country’s efforts to keep COVID-19 under control. As the global health community continues to adapt to the evolving challenges of the pandemic, companies like CoSara will remain essential in offering accurate, efficient, and accessible diagnostic tools.

The Saragene test’s approval represents more than just a product launch for CoSara Diagnostics; it is a critical step in supporting national and international public health efforts to detect and mitigate the spread of COVID-19. As the need for COVID-19 testing persists, CoSara’s commitment to affordability and quality will likely position the company for continued success in the evolving diagnostics market.