US-based biotechnology company PHASE Scientific has received the CE Mark approval for its PHASIFY Viral RNA extraction kit.
The approval enables the company to expand commercialisation of the kits to the EU and other countries amid the ongoing fight against the Covid-19 pandemic.
PHASIFY is designed to purify and concentrate RNA in patient viral transport media samples. It facilitates greater SARS-CoV-2 RNA yields.
It improves input sample quality, enabling earlier detection and increased overall sensitivity and builds confidence in Covid-19 diagnostic test results.
According to the company, in-house and clinical validation data have shown that kit can offer a three-six cycle threshold reduction compared to solid-phase extraction.
Clinical studies have also found that the kit increases true positive detection compared to conventional solid-phase extraction.
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This capability is fulfiled through PHASE Scientific’s proprietary technology PHASIFY that isolates and concentrates target molecules, making them easier to detect, the company said.
In addition, PHASIFY increases the sample input volume up to 600µL per extraction and enhances final viral RNA concentration with flexible elution volumes down to 10µL.
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.”
PHASE Scientific noted that the viral RNA extraction kit is part of global efforts in detecting and containing the Covid-19 disease.
The company has developed a range of products, including antibody rapid tests, sample preparation kits and RT-qPCR kits to combat the virus.