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December 8, 2021updated 07 Jan 2022 8:22am

CoSara’s Saraplex RT-PCR test receives Indian regulator approval

The Saraplex multiplex RT-PCR test is developed using Co-Diagnostics’ CoPrimer technology.

By Darcy Jimenez

Co-Diagnostics’ joint venture (JV), CoSara Diagnostics, has secured clearance from the Indian Central Drugs Standard Control Organisation (CDSCO) for its Saraplex Flu A/Flu B/COVID-19 (ABC) multiplex reverse transcription-polymerase chain reaction (RT-PCR) test.

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The approval allows CoSara to manufacture and sell its new ABC multiplex test as an in vitro diagnostic (IVD) test in the Indian market.

Developed using Co-Diagnostics’ CoPrimer technology, the new Saraplex multiplex RT-PCR test is intended to detect and differentiate SARS-CoV-2, influenza A and influenza B simultaneously.

It is said to be CoSara’s fourth assay to receive CDSCO approval this year.

The test uses nasopharyngeal or oral swab, bronchial lavage, tracheal aspirate, sputum, or saliva samples.

Co-Diagnostics CEO Dwight Egan said: “As we continue to see variants arise and spread across the world, it has never been more important to have access to reliable, accurate and affordable diagnostics as the first line of defence, and we are pleased about the role our CoPrimer technology is playing across the world to help increase this availability.”

The company stated that CoSara’s other tests designed to detect the SARS-CoV-2 virus remain effective in identifying all variants of the virus, including the emerging Omicron variant.

CoSara director Mohal Sarabhai said: “With several million cases of severe flu infections every year, and with such similar symptoms to the ever-mutating Covid-19, accurately detecting and distinguishing between these diseases will play a vital role in bolstering the global healthcare response to respiratory illnesses.

“We are excited to be able to provide additional tools to our growing client base to assist in these efforts in accordance with the ‘Make in India’ initiative and to address the needs of the Indian market and the surrounding region.”

Previously, the company secured approval from CDSCO for its RT-PCR tests designed to detect hepatitis B, hepatitis C, human papillomavirus (HPV), chikungunya, dengue, Mycobacterium tuberculosis and malaria.

The tests also received clearance for manufacturing and sale as IVDs in India.

CDSCO also approved the company’s dengue/chikungunya duplex test and two Covid-19 assays.

Last year, CoSara Diagnostics obtained CDSCO’s clearance for its Saragene COVID-19 2-gene multiplex RT-PCR test.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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