Purigen Biosystems Adds CE Mark for Launch of Ionic® Purification System in UK and EU
PLEASANTON, Calif .– (BUSINESS WIRE) –Purigen Biosystems, Inc., a leading provider of next-generation technologies for the extraction and purification of nucleic acids from biological samples, today announced the CE (Conformité Européene) mark for its Ionic® purification system. Purigen has certified that its products meet European Union requirements for performance, safety and relevant product and service standards. With this mark, Purigen is now able to support clinical and oncology researchers in the European Union and other CE Mark geographies, including the UK. Purigen is also expanding its business operations to help meet growing global demand for its premier nucleic acid purification technology.
Introduced to the U.S. market in 2019, the Small Benchtop Ion Purification System enables automated nucleic acid extraction with dramatically increased yield and quality from a wide variety of sample types, including cells. cultured or sorted and formalin fixed cells embedded in paraffin (FFPE) tissue. Biological samples are gently lysed and then loaded into the Ionic® Fluidics chip. The system then applies an electric field to the chip and the nucleic acids are isolated in their natural and native form using the company’s core isotachophoresis (ITP) technology. Since nucleic acids are not bound or detached from fixed surfaces, nucleic acid loss and fragmentation is minimized while purification induced bias is eliminated. The streamlined 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 from the Center for Environment Fisheries and Aquaculture Science (CEFAS) in the UK, will use the Ion Purification System in non-clinical research applications to study diseases of commercially grown and harvested fish and shellfish, as well as microbial risks to human health from shellfish and other aquatic sources. The team purifies RNA and DNA from FFPE tissue samples taken from animals, algae, bacteria, and other aquatic samples prior to qPCR and NGS analysis.
“Our work at CEFAS provides policy and scientific advice globally to improve food security and protect public health,” said David Bass, PhD, senior researcher at CEFAS. “Our FFPE samples are limited and the Purigen technology provides us with more nucleic acid for our genomic testing through a very simple workflow. This will be particularly valuable for our roles at the head of the OIE Collaborative Center for Emerging Aquatic Animal Diseases and the FAO Reference Centers for Antimicrobial Resistance and Sanitation of Bivalve Molluscs. ”
“Over the past year, we have seen increasing interest in our innovative ionic purification system around the world, particularly in the UK and the European Union,” said Barney Saunders, PhD, CEO of Purigen Biosystems. “I am proud that our team was able to quickly shift priorities to obtain the appropriate regulatory approvals, which allowed us to expand our business operations. Today, we are now in a position to give more clinical researchers in Europe the opportunity to maximize the utility of their precious samples. ”
Components of the ionic purification system
The complete ionic purification system consists of the following components:
- The Ionic® purification instrument – A small benchtop system driven by a simple touch screen interface that can process an Ionic® fluidics chip with eight samples in about an hour.
- Ionic® FFPE to Pure DNA Kit – Consists of six microarrays and a reagent set with all the enzymes and buffers needed to perform DNA extraction directly from 48 FFPE tissue samples.
- Ionic® FFPE to pure RNA kit – Consists of six microarrays and a reagent set with all the enzymes and buffers needed to perform RNA extraction directly from 48 FFPE tissue samples.
- Complete Ionic® FFPE purification kit – Consists of 12 microarrays and a reagent set with all the enzymes and buffers needed to perform simultaneous DNA and RNA extraction from 48 samples.
- Ionic® Cells to Pure DNA Kit – Consists of six microarrays and a set of reagents with all the enzymes and buffers needed to perform cell lysis and DNA extraction from cells grown or sorted in up to 48 samples.
About Purigen Biosystems
Purigen Biosystems redefines nucleic acid sample preparation with an innovative platform based on the highly efficient isotachophoresis technology invented by Juan Santiago, PhD, and his team at Stanford University. Purigen’s automated benchtop instrumentation and accompanying microfluidic chip purify nucleic acid samples from a wide variety of sources, including tiny or difficult cancer samples. The purified nucleic acids are then immediately compatible with a wide range of downstream detection methods, including next generation sequencing, PCR and other genomic assays. For more information visit www.purigenbio.com.
Ionic is a registered trademark of Purigen Biosystems, Inc. All other trademarks are the property of their respective owners. All products described in this document are intended for RESEARCH ONLY and NOT FOR USE IN DIAGNOSTIC PROCEDURES.