Purigen Biosystems gets CE mark for nucleic acid isolation system

Purigen Biosystems, Inc., a leading provider of next-generation technologies for extracting and purifying nucleic acids from biological samples, has announced the CE (Conformité Européene) marking of its Ionic^® Purification System. Purigen has certified that its products comply with the European Union’s performance, safety, and relevant product and service standards requirements. With the marking, Purigen is now able to support clinical and oncology researchers across the European Union and other CE Mark geographies, including the UK. Purigen is also expanding its commercial operations to help meet the growing worldwide demand for its best-in-class nucleic acid purification technology.

Launched in the US market in 2019, the small benchtop Ionic Purification System enables the automated extraction of nucleic acids with dramatically increased yield and quality from a wide range of sample types, including cultured or sorted cells and formalin-fixed, paraffin-embedded (FFPE) tissues. Biological samples are gently lysed and then loaded into the Ionic^® Fluidics Chip. The system then applies an electrical field to the chip and the nucleic acids are isolated in their natural, native form using the company’s core isotachophoresis (ITP) technology. Since the nucleic acids are not bound or stripped from fixed surfaces, nucleic acid loss and fragmentation are minimized while purification-induced bias is eliminated. The simplified workflow requires minimal hands-on time and produces higher yields of high-quality RNA and DNA that are truly representative of the starting sample.

Scientists at the Centre for Environment Fisheries and Aquaculture Science (CEFAS) in the UK will be using the Ionic Purification System in non-clinical research applications to study diseases of commercially cultured and harvested fish and shellfish, along with microbial risks to human health from shellfish and other aquatic sources. The team is purifying RNA and DNA from FFPE tissue samples collected from animals, seaweeds, bacteria, and other aquatic samples prior to qPCR and NGS analysis.

“Our work at CEFAS provides policy and scientific advice globally to enhance food security and to protect public health,” said David Bass, PhD, Principal Investigator at CEFAS. “Our FFPE samples are limited and the Purigen technology provides us with more nucleic acid for our genomic assays via a very simple workflow. This will be particularly valuable for our roles leading the OIE Collaborative Centre for Emerging Aquatic Animal Diseases, and FAO Reference Centres for Antimicrobial Resistance and Bivalve Mollusc Sanitation.”

“Over the past year, we have seen increasing interest in our innovative Ionic Purification System from around the world, especially in the UK and European Union,” said Barney Saunders, PhD, CEO of Purigen Biosystems. “I’m proud that our team was able to quickly shift priorities to secure the appropriate regulatory approvals, which has enabled us to expand our commercial operations. Today, we are now able to empower more clinical researchers in Europe with the ability to maximize the utility of their precious samples.”

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