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RevoluGen Continues Push Into IVD Market With New Nucleic Acid Prep Kit


This article has been updated from a previous version to clarify RevoluGen's corporate history.

NEW YORK (GenomeWeb) – RevoluGen, a privately held scientific research and development company that has spent the last several years digging into the in vitro diagnostics industry, last month launched a new IVD-specific nucleic acid purification and isolation kit.

The company has spent the last three years developing point-of-care diagnostic tests for Neisseria gonorrhoea and Chlamydia trachomatis, CEO Pieter Mulier told GenomeWeb.  Both tests are currently in clinical trials at St. George Hospital as part of a study sponsored by Public Health England, and the company expects to report results from the trial in September, he said.

In the meantime, the company expects to get a CE IVD mark for its new sample prep kit, the Purispin Fire Monkey, later this year, Steven Minter, RevoluGen's chief scientist and inventor of the kit, told GenomeWeb. 

RevoluGen is headquartered in Hannover, Germany, and runs a laboratory in Derbyshire, UK. While the company has been around for about 20 years, it rebranded itself as RevoluGen one month ago. Previously, it was known as Moorlodge Biotech Ventures. The company has spun off a number of successful businesses including Tepnel Pharma Services, now a subsidiary of Hologic, and Platform Diagnostics, which develops platform technologies for the in vitro diagnostics industry. Its recently recruited executive team has decades of experience in the biotechnology industry and the company is rapidly expanding. 

Minter and his colleagues identified a need for a simple system to prepare target material for testing in a broad range of applications, including as sample preparation for the company's diagnostic assays. The result is the Purispin kit that allows researchers to "isolate and purify both RNA and DNA" from bacteria, tissue, and blood samples, he said.

The kit uses what the company calls a "gentler" chemistry that can produce longer DNA lengths, creates less contamination, and produces higher yields. It is an aqueous-based chemistry that is performed by centrifugation. It also doesn't use alcohols, which are often used to isolate and extract nucleic acids but can be toxic and require the process to be done under a fume hood. The worst offender, β-mercaptoethanol, is used in many competing kits which creates a healthy and safety risk for researchers performing the extraction, Minter said. 

Purispin is "room temperature safe" and has at least a twelve-month shelf life, Minter said. Another advantage is its versatility: It can be directed midway through the extraction process to deliver total nucleic acid, pure DNA, or pure RNA from the same sample. The kit can be used to prepare samples for next-generation sequencing, PCR, and hybridization systems, Minter said.

Erling Refsum, a biotech analyst consultant for RevoluGen, told GenomeWeb that the kits have been independently tested by researchers at Dundee University, who have measured its DNA integrity number as 9.5 out of 10 compared to an average of 8.5 out of 10 for most competing kits, including from companies such as Qiagen and Roche. 

The company believes that its product has many advantages over other products on the market. "Our Purispin Fire Monkey kit performs what the competitors need many different kits [to do]," Minter said. Qiagen, for example, sells different kits to extract DNA versus RNA, to extract sequences of varying lengths, and to deal with nucleic acid extraction and isolation from different types of sources.

The Dundee researchers also confirmed that the DNA they were able to extract using the kits comprised at least 60,000 base pairs, Refsum said. RevoluGen has also consulted with researchers at Warwick University, who have developed a new technique for measuring DNA lengths that suggests that the Purispin kit may yield DNA lengths of up to 120,000 base pairs, Refsum added. For researchers, the longer base pair lengths are desirable because they result in better quality sequencing reads with much lower error rates.

"It also does the whole range [of] RNA [base pair lengths] from the long all the way down to the small 17-base-pair RNA sequences, even when the original samples are old and poorly stored," Refsum said. The company demonstrated this by having researchers use the Purispin kit on some tiny, old, and badly stored leukemia samples. Previous attempts to extract DNA from these samples failed, but the researchers were able to extract DNA using RevoluGen's kit, he said.

The company is only marketing through one distribution partner — Nottingham, UK-based Scientific Laboratory Services, or SLS — and is limiting its product launch to Europe at the moment. The company said the list price for the product is £325 ($460) for 100 columns, but it is currently offering the kit at a discount price of £196 ($278) for 100 columns.

RevoluGen expects to get CE IVD marking for the kit by November. In addition, it plans to expand distribution across Europe and into the US market at a future date, CEO Pieter Mulier said. However, the company doesn't yet have a US-based distributor nor approval from the US Food and Drug Administration, which means that right now the kit can only be used for research purposes in the US, he said.

The company is also working on a version of the kit that would use magnetic beads rather than centrifugation, but with the same chemistry. "We suspect that [the magnetic beads] will be even gentler [on the DNA] and we will get even longer [sequences]," Refsum said. The company hopes to have the new version of the kit available for launch around January 2017.