By Ben Butkus
Enigma Diagnostics and Tecan said this week that they have signed a licensing and collaboration agreement that will enable Tecan to use Enigma's intellectual property to develop a fully integrated, PCR-based molecular diagnostics platform for a third party in the molecular testing space.
The agreement builds upon an existing OEM pact between the companies under which Tecan is manufacturing and will help market Enigma's forthcoming Enigma ML testing device for the point-of-care and low-complexity laboratory markets, Enigma chairman and CEO John McKinley told PCR Insider this week.
McKinley also disclosed that the commercial launch of the Enigma ML platform, originally planned for the fourth quarter of 2010, has been delayed until later this year due to previously unforeseen changes in the manufacturing and supply chain surrounding the benchtop testing instrument, McKinley said.
Under Enigma and Tecan's latest agreement, Tecan will have access to Enigma IP originally developed by the UK's Ministry of Defence and which Tecan to this point has exclusively employed in the Enigma ML platform. This IP includes proprietary sample-prep methods and miniaturized thermal cycling that employs electric conducting polymer technology.
Tecan will then work with Enigma to develop what the companies called a "next-generation molecular diagnostics platform for a potential OEM partner." The envisaged platform includes enabling consumables and features such as random sample access, complete walkway automation, a small footprint, and a rapid time to result, the companies said.
It is unclear whether Tecan would develop the platform for a specific OEM partner, or whether it will pitch the new platform to a number of potential partners. Tecan did not respond to interview requests.
However, in a statement, Tecan CEO Thomas Bachmann said that the license provides Tecan with "the opportunity to approach a potential OEM partner with our concept of an integrated solution for molecular diagnostics that includes a unique instrument as well as enabling consumables."
According to McKinley, while the Enigma ML is designed for low-complexity labs and the POC testing market; the new platform would be designed for moderate- and high-complexity testing laboratories. The Enigma ML, still under development, has a throughput of around 50 to 60 samples per eight hours. According to McKinley, the new platform would have an "order of magnitude" higher throughput, although he declined to provide specifics because specifications for the new platform have not yet been completed.
McKinley said the new platform can be thought of as integrating several "modules," each of which would have similar capabilities to the Enigma ML.
"We're taking the same random-access capabilities into the higher throughput instrument system, and that's something that few if any of the current instruments have," he said. "It allows a lower user technical capability, and it will be about the same speed as the ML, with results in about 30 minutes to an hour.
"And it will have the cost to be competitive," McKInley added. "The higher throughput market is very cost-competitive, we recognize that; and so everything Tecan is doing is geared toward the lowest cost possible for the consumables that are going to be used with that system."
The companies did not provide a commercialization timeline for the new platform.
In the meantime, Enigma and Tecan are focusing on bringing to market the Enigma ML. Early last year, the companies inked a five-year agreement under which Tecan agreed to manufacture and market the Enigma ML on a worldwide basis (PCR Insider, 2/11/2010).
At the time, Enigma said it was eyeing a Q4 2010 launch for the ML in Europe in partnership with GlaxoSmithKline for point-of-care detection of specific influenza strains. The goal of the partnership, which was inked in July 2009, was to develop the Enigma ML to deliver fully-automated results from swab samples in less than 60 minutes at the point of care and to the same accuracy standards as reference laboratories.
However, this week McKinley said that the commercialization timeline has been pushed back to "late summer or early fall" of this year due to a change in the manufacturing and supply chain for the platform.
"In fall 2010 we decided that we would transfer certain parts of that manufacturing and supply chain to the Far East, which is what we have done," McKinley said. "That has resulted in somewhat of a delay in the initial launch, but by doing so we now have much more highly transferrable and scalable manufacturing in the Far East. It makes it easier for our commercial partners in due course."
McKinley added that Tecan and Enigma are now "moving through the final production phase for the instrument," and would likely first seek a CE IVD Mark followed by a 510(k) application with the US Food and Drug Administration. "That obviously takes a much longer time, and we don't have a final idea of that," he said. "We hope in early 2012."
McKinley also noted that Enigma is discussing a "range of other assays with potential partners, but the first test is likely to be for influenza.
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