PHASE Scientific Announces CE Mark Approval for the PHASIFY(TM) VIRAL RNA Extraction Kit

July 20,2020

PHASE Scientific, a fast-growing biotechnology company, announces today it has received the Conformité Européene (CE) Mark approval for its PHASIFY™ VIRAL RNA Extraction Kit. The CE marking confirms that PHASIFY™ VIRAL complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC), which enables PHASE Scientific to expand commercialization of PHASIFY™ VIRAL to the European Union and other CE Mark geographies as part of the fight against COVID-19.

The PHASIFY™ VIRAL RNA Extraction Kit is designed to purify and concentrate viral RNA in patient viral transport media samples, and is intended as part of global efforts in detecting and controlling the COVID-19 disease. Attested by the company, PHASIFY™ VIRAL improves input sample quality, enabling earlier detection, improved overall sensitivity and bolsters confidence in COVID-19 diagnostic test results.

According to Jeffrey D, Klausner, Ph.D., Principal Investigator at the National Institutes of Health (US) and Professor of Medicine and Public Health at UCLA, input sample quality is a major bottleneck in COVID-19 detection accuracy, "unfortunately, as only miniscule amounts of viral RNA exist in patient samples, most conventional viral RNA extraction kits encounter constraints in both sample input volume and final elution volume, which results in only 1-2% of the total viral RNA available for analyses. That suggests the current viral RNA extraction kits play a major role in limiting analytic sensitivity."

"Utilizing PHASIFY™ VIRAL RNA extraction can result in 15-30-fold greater amount of viral RNA for standard RT-qPCR analyses," says Klausner. "The increased sample quality can improve analytic sensitivity and reduce false negative results."

The PHASIFY™ VIRAL product can facilitate greater SARS-CoV-2 RNA yields. According to the company, in-house and clinical validation data have shown PHASIFY™ VIRAL can enable a 3-6 cycle threshold reduction compared to solid phase extraction. Clinical studies have also shown PHASIFY™ VIRAL increases true positive detection compared to conventional solid phase extraction.

This capability is realized through PHASE Scientific's proprietary technology PHASIFY™, which has the ability to isolate and concentrate target molecules, making them easier to detect. Incorporating the technology can make diagnostic tests more affordable, accessible, faster, easier, and more accurate.

Additional advantages of PHASIFY™ VIRAL include the ability to increase the sample input volume up to 600µL per extraction and enhance final viral RNA concentration with flexible elution volumes down to 10µL. Its easy-to-use design requires no additional specialized equipment such as magnetic racks and vacuum pumps for operation.

PHASE Scientific has developed an array of products to combat COVID-19, which includes antibody rapid tests, sample preparation kits, and RT-qPCR kits.

"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," says PHASE Scientific Founder and CEO Ricky Chiu, Ph.D. "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."