Global medical device major Thermo Fisher Scientific will introduce a new and innovative point-of-care COVID-19 test platform in the Indian market which can give result in about 30 minutes.
The Accula SARS-CoV-2 Test carries out the reverse transcription polymerase chain reaction (RT-PCR) detection of COVID-19 virus and has received emergency use authorization (EUA) from the United States Food and Drug Administration (FDA) for detection of SARS-CoV-2 in Clinical Laboratory Improvement Amendments (CLIA)-waived environments.
Currently, kits approved by USFDA and drug regulatory agencies of European Union, Japan, Korea, Australia and Brazil under regular or emergency use are exempted from validation in India and qualify for direct marketing permission from the Drug Controller General of India (DCGI).
"Thermo Fisher's new testing platform combines the accuracy of RT-PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays. The Accula SARS-CoV-2 Test is natural extension to our existing offerings and will significantly help to meet the continuing demands for rapid and reliable COVID-19 testing in India," Amit Chopra, Managing Director for India and South Asia at Thermo Fisher Scientific said.
"The rapid Accula point-of-care test will open new avenues of personal and public testing without compromising on accuracy," he added.
According to a company statement, the new platform ensures RT-PCR testing is streamlined from start to finish using a fully integrated, single-use microfluidic test cassette and the reusable, palm-sized Accula Dock.
"The test uses nasal swab samples and provides reliable, qualitative results in approximately 30 minutes. The Accula SARS-CoV-2 Test is enabled by proprietary PCR technology that allows for reduced absolute temperatures and reduced temperature differentials-resulting in rapid exponential amplification while reducing overall thermocycling times", it said.
Chopra said the introduction of the test in India is a demonstration of the impact the company's solutions have on human health during the pandemic, and far beyond.
In January 2021, the $30 billion Thermo Fisher acquired Mesa Biotech Inc., which had developed the Accula SARS-CoV-2 Test to provide accurate and faster results at the point of care. The company employs 80,000 people globally through its industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
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