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Purigen Biosystems Targets FFPE DNA Extraction Market

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This story has been updated to include commens from Purigen Biosystems about its planned product launch in April.

NEW YORK – Purigen Biosystems, a Stanford University spinout, is looking to get into the nucleic acid extraction and purification market by first carving out a niche with kits for formalin-fixed paraffin-embedded (FFPE) samples, a segment the firm values at $800 million.

Purigen's first assay, launched earlier this year, is for DNA extraction from FFPE tissues. It's a step into a segment of the clinical sample preparation market that Purigen CEO Barney Saunders believes to be worth about $800 million. An FFPE RNA extraction assay is also in the works.

The kits are part of Purigen's Ionic Purification System, launched in November 2019, for extraction and purification by isotachophoresis, an electrophoresis-based approach to separation. The platform carries a list price of $49,900 in the US.

Purigen's assays can generate three times as much nucleic acid as established column- or bead-based methods, Saunders said, and with better purity and less damage to the analyte. "That really counts for clinical specimens where you've got a small amount," he said. Per-sample cost varies depending on the type of tissue, but ranges from $6 to $10 and includes all components necessary for lysis and separation.  The FFPE kit contains six microfluidic chips the size of microplates, each with a capacity of eight samples, for a total of 48 samples per kit. The platform output is compatible with several downstream applications, including PCR and next-generation sequencing, Saunders said.

The firm is targeting the translational research market, including government and academic research centers and biopharmaceutical companies, especially those interested in oncology research. The company has placed instruments with customers, including two at a "world-leading cancer center," Saunders said, but he declined to disclose further details.

Founded in 2012 to commercialize the isotachophoresis method for extracting nucleic acids, developed by Stanford professor and company CSO Juan Santiago, Purigen has grown with more than $44.6 million in private financing and the help of two Phase I Small Business Innovation Research awards from the National Human Genome Research Institute, including an award of $149,960 in 2016 to develop FFPE nucleic acid extraction capability. Isotachophoresis achieves nucleic acid separation by running cell lysate through a microfluidic chip with electric current. DNA and RNA move more easily than other analytes; sandwiching the nucleic acids between reagents that move either slightly faster or slower through the channel helps concentrate them for later capture. 

The firm has 35 full-time employees at its Pleasanton, California headquarters and is looking to build out its commercial team. Both R&D and commercial operations, as well as some manufacturing, are run out of the 16,000 square foot facility.

The company planned to launch an FFPE RNA kit at the American Association of Cancer Research annual meeting next month, however, the conference was cancelled on Tuesday over concerns about COVID-19. Purigen said in an email it planned to go ahead despite the cancellation, but noted "this is a fluid situation and right now our main focus is on the safety and health of our employees, families, and members of our community... we will continue to evaluate this situation and adjust our launch plans as needed over the next month." 

The firm also plans to develop nucleic acid extraction products for use with fresh frozen samples.

Purigen enters a market dominated by other technologies. Saunders identified Qiagen as the market leader with its column-based and spin column technology. Earlier this month, Thermo Fisher Scientific announced plans to buy Qiagen for $11.5 billion. Thermo Fisher also makes DNA purification and extraction products, including its KingFisher Purification systems, as well as products for DNA electrophoresis.

Several other companies have been developing novel technologies for DNA extraction, especially high molecular weight DNA for long-read sequencing or mapping, including Circulomics, Sage Science, and RevoluGen. 

But Purigen is the only company offering isotachophoresis, a process that doesn't require deparaffinization, leading to faster and more efficient workflow, Saunders claimed. And because it doesn't require binding, it more easiliy captures high-GC content molecules, something bead-based methods struggle with.

"We have substantial data that shows our customers and future customers they'll not only get more yield, but more amplifiable material out of that," Saunders said. "If you're doing panel-based sequencing, what you see is more accuracy and less dropout." However, the company has not yet gotten that data published in a peer-reviewed paper. 

In addition to being available to buy the platform outright, Purigen offers to place "demonstration instruments" into interested labs. It also offers a service to prepare samples in house, for which it charges a fee. This generates nominal revenue for the company, but Saunders said the main reason for the practice is to reach more serious customers — which he found to be the case while serving as chief commercial officer at NanoString Technologies.

Saunders suggested that oncology is where the company will focus its early sales and marketing efforts. While the greater nucleic acid extraction market is worth as much as $2.5 billion, Saunders said, his company will focus on "identifiable target customers" at academic research centers running clinical trials.

But he hopes to continue to grow the business and said he is planning to raise more money, potentially a "very significant amount."

"Any of the assays where people are using focused panels to look for sequence variants" could benefit from sample prep with Purigen's technology," he said. "Some bigger companies have emerging applications and are testing out [Purigen's technology] to see if they benefit."

While the firm has a special relationship with Agilent — Agilent VP and general manager Kevin Corcoran is on the board of directors — the platform's end result is nucleic acid in an elution buffer that is "designed to be compatible with major vendors," Saunders said. 

So far, Purigen hasn't announced any major partnerships with other companies, though.

"Longer term, I'm sure we will," Saunders said.

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