INEX Innovate's CORO(TM) Real-Time RT-PCR SARS-CoV-2 Kit for the detection of COVID-19 obtains Singapore's Health Sciences Authority Provisional Authorisation

2020-12-29 17:24 1561
  • The COVID-19 pandemic has seen in excess of 81 million confirmed cases globally and more than 1.7 million deaths and rising daily (1)
  • CORO™ Real-Time RT-PCR SARS-CoV-2 for the diagnosis of COVID-19, was developed based on three genes recommended by the World Health Organisation (WHO)
  • Singapore's Health Sciences Authority has given provisional authorisation for CORO™ to be used in Singapore.

SINGAPORE, Dec. 29, 2020 /PRNewswire/ -- INEX Innovate Pte Ltd a Singapore based molecular diagnostics developer today announced that the Singapore Health Sciences Authority has issued provisional authorisation to the company's CORO™ Real-Time RT-PCR SARS-CoV-2 for the diagnosis of COVID-19.

INEX Innovate announces its CORO Real Time RT-PCR SARS-CoV-2 kit has received Provisional Authorisation from Singapore's Health Sciences Authority
INEX Innovate announces its CORO Real Time RT-PCR SARS-CoV-2 kit has received Provisional Authorisation from Singapore's Health Sciences Authority

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, Chief Executive Officer 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.



Spun out from the National University of Singapore (NUS), INEX INNOVATE is Asia's first Women's Life Science Health Innovations group. Founded by veteran maternal-fetal medicine specialists, INEX is uniquely positioned to identify and address clinically unmet needs within the women's and fetal health landscape. Backed by institutional investors, INEX focuses on developing and translating technologies aimed at delivering precision health care for Asian women.

INEX has a broad commercial portfolio of validated tests in prenatal health, ovarian and breast cancers along with more than 45 key patents, additionally, through its wholly owned subsidiary iGene Laboratory, INEX operates a state of the art College of American Pathologist Accredited Next Generation Sequencing Laboratory that provides diagnostic testing, CRO and COVID-19 testing services. In 2020 the company was a finalist in the Business Transformation of the Year award category at the British Chamber of Commerce Singapore Annual Business Awards in recognition of its efforts in launching new technologies and pivoting towards COVID-19 testing to support Singapore's battle against the corona virus pandemic.

INEX Innovate is headquartered in Singapore with subsidiaries in Hong Kong, Indonesia and the United Kingdom.

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Source: INEX Innovate