31 December 2020 | News
CORO™ Real-Time RT-PCR SARS-CoV-2 for the diagnosis of COVID-19 was developed based on three genes recommended by the WHO
Photo Credit: PRNewswire
INEX Innovate, a Singapore-based molecular diagnostics developer, has announced that the Singapore Health Sciences Authority has issued provisional authorization to the company's CORO™ Real-Time RT-PCR SARS-CoV-2 for the diagnosis of COVID-19.
COROTM Real-Time RT-PCR SARS-CoV-2 kit is a multiplex real-time molecular diagnostic test for diagnosis of SARS-CoV-2 in accordance to WHO and Centre of Disease Control recommendations whereby several genes are used for positive diagnosis.
The kit utilizes both the RNA-dependent RNA polymerase (RdRp) and Spike (S) genes for screening and confirms SARS-CoV-2 positive diagnosis by detecting the Nucleocapsid (N) gene. The kit contains a specific ready-to-use system for the virus detection by RT-PCR (Reverse Transcription Polymerase Chain Reaction) in the real-time PCR system.
"The approval of CORO™ marks a major advancement for the company in its continuing evolution in the diagnostics space," said Kane Black, CEO of INEX Innovate. "With the world currently in the midst of a global pandemic, we are thrilled to be able to offer an accurate yet low cost option."
Leveraging upon the company's distribution platform across Asia and beyond, INEX plans to market and distribute the CORO™ test kit in Bangladesh, Cambodia, Indonesia, Myanmar, Philippines and the United Kingdom amongst others.
In addition, INEX Innovate has two further COVID-19 devices undergoing regulatory authority review – the first being an Antigen Rapid Test (ART) which detects the antigens on the surface of the virus, to identify those who have high levels of virus in the body while the second is a lateral flow immunochromatographic assay, which requires a small amount of patient's blood, which detects antibodies IgG and IgM to determine the patient's virus contraction history.