The new extraction kit will help purify and concentrate viral RNA in patient viral transport media samples
Biotechnology company PHASE Scientific has secured CE mark approval for its PHASIFY VIRAL RNA extraction kit.
The CE mark approval enables PHASE Scientific to expand commercialisation of the extraction kit in the European Union and other CE mark accepting countries to better fight against Covid-19 disease.
PHASE Scientific has developed the new extraction kit to purify and concentrate viral RNA in patient viral transport media samples, helping to efficiently identify and control the novel coronavirus disease.
According to the company, the in-house and clinical validation data have demonstrated that the new extraction kit has the capacity to facilitate a 3-6 cycle threshold reduction compared to solid-phase extraction.
Clinical studies have also demonstrated that PHASIFY VIRAL enhances true positive detection compared to conventional solid-phase extraction, said the company.
PHASE Scientific also offers antibody rapid tests, sample preparation kits, and RT-qPCR kits to better detect Covid-19 disease
The company’s PHASIFY is an advanced technology that allows to isolate and concentrate target molecules, helping in the easy detection of the virus.
PHASIFY VIRAL can also increase the sample input volume up to 600µL per extraction, in addition to enhancing final viral RNA concentration with flexible elution volumes down to 10µL.
PHASE Scientific is also offering antibody rapid tests, sample preparation kits, and RT-qPCR kits for the efficient detection of Covid-19 disease.
PHASE Scientific founder and CEO Ricky Chiu said: “PHASIFY™ VIRAL, as part of our many contributions for containing the global pandemic, marks a new step forward for both the company and our global collaborators in detecting and controlling the Covid-19 disease.
“Akin to other countries, we are confident our entry into the European market can benefit both healthcare providers and patients in the region to accelerate the return of healthier communities and the re-opening of global economies.”
In May, GenScript Biotech Europe secured CE mark approval for its SARS-CoV-2 diagnostic products to market as in vitro diagnostic (IVD) products.