Veredus Laboratories’ VereCoV detection kit obtains provisional approval for IVD use

With the authorization by HSA, the VereCoV Detection Kit can be used directly by laboratories or hospitals to test patients for clinical diagnosis as an in-vitro diagnostic product (IVD).
By Dean Koh
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Last week, Singapore-based Veredus Laboratories announced that it has obtained the Provisional Authorization from the Singapore Health Sciences Authority (HSA) for its VereCoV Detection Kit following the company’s rapid launch of this kit as a “Research Use Only” (RUO) test in late January, which was reported by MobiHealthNews here.

The VereCoV Detection Kit is a collaborative effort between Veredus and the Home Team Science and Technology Agency (HTX) Chemical, Biological, Radiology, Nuclear and Explosives (CBRNE) Centre of Expertise. HTX, which was officially launched in December 2019, is a statutory board under the Ministry of Home Affairs to develop science and technology capabilities for Home Team operations in Singapore. 

WHY IT MATTERS

With the authorization by HSA, the VereCoV Detection Kit can be used directly by laboratories or hospitals to test patients for clinical diagnosis as an in-vitro diagnostic product (IVD). As a multiplex RT-PCR and microarray-based test, VereCoV Detection Kit integrates an ultra-fast miniaturized PCR reactor for the amplification of nucleic acids and a customized microarray to qualitatively detect 2019 novel coronavirus (2019-nCoV or COVID-19) with the additional capability of detecting a subset of Severe Acute Respiratory Syndrome (SARS-CoV) simultaneously within the same test. 

This allows users who are operating in real-world situations to apply the full benefit of molecular testing at a fraction of the time, cost and complexity.

THE LARGER TREND

A group of researchers at the Institute for Health Innovation & Technology (iHealthtech) located at the National University of Singapore (NUS) is also working on the development of a rapid Wuhan novel coronavirus (2019-nCoV) detection kit, based on the enVision technology platform that they invented in 2018, MobiHealthNews reported

The iHealthtech research team estimates that the new Wuhan novel coronavirus (2019-nCoV) detection kit will take a few months before hitting the market. According to a study by Harvard University researchers, “Singapore historically had very strong epidemiological surveillance and contact-tracing capacity and has shown in the COVID-19 epidemic evidence of a high sensitivity of case detection.” The nation-state's approach for detecting COVID-19 has been described as the “gold standard” by several media outlets. 

ON THE RECORD

“The test kit is designed with the capability to detect COVID-19 with high specificity and sensitivity, similar to how a key with a specific design will be able to open the corresponding lock,” said Ms Ong Bee Leng, director of the HTX CBRNE Centre of Expertise, in a statement.

“We are pleased to partner with Veredus in such a crucial time to collaborate on an innovative solution to detect COVID-19 for our national interest and to support the global need to prevent the further spread of the virus.”

Dr Rosemary Tan, CEO of Veredus Laboratories, said, “The next critical step would be for our kit to play an important role in the clinical diagnosis of COVID-19 within the healthcare community.”