This story was originally published on Feb. 9.
By Ben Butkus
Enigma Diagnostics has taken an important step toward commercializing its PCR-based, point-of-care molecular diagnostic platform by inking a global manufacturing and supply agreement with Tecan.
Enigma, based in Oxford, UK, said that it struck the alliance with Tecan in anticipation of a fourth-quarter commercial launch of its platform for point-of-care influenza diagnostic tests in Europe in partnership with GlaxoSmithKline.
In addition, Enigma finds in Tecan an experienced scientific instrumentation vendor with international reach to support a planned foray into the molecular diagnostics market in other parts of the world, including the US, Enigma Chairman and CEO John McKinley told PCR Insider last week.
Under the five-year agreement, the financial terms of which were not disclosed, Tecan will manufacture and market Enigma's platform, called the Enigma ML ("mini-laboratory"), on a worldwide basis.
The Enigma ML is a fully automated, multi-sample instrument based on real-time PCR. It features miniaturized versions of the same technology employed in the company's Enigma FL (field laboratory) platform, which it designed in collaboration with the UK Ministry of Defense and launched in November 2008 for the defense and veterinary markets.
The ML platform is highly portable, user friendly, and features simple sample preparation technology, making it ideal for the point-of-care diagnostic testing market, McKinley said.
"We've tried to produce the instrument for ease of use, and to have the lowest technical user requirement," McKinley told PCR Insider. "That stems from Enigma's military and defense background. In the field you want to be able to use equipment with the lowest level of technical capability available."
Enigma has an exclusive license from the UK's Defense Science Technology Laboratory to a portfolio of patents representing more than 15 years of Ministry of Defense-funded work; as well as freedom-to-operate licenses from Life Technologies' Applied Biosystems unit; Celera; and Roche to commercialize real-time PCR instruments and assays across diagnostic and applied markets.
The company also has a portfolio of more than 50 patent families worldwide protecting innovations made through its own internal R&D activities.
"We have our own unique thermal cycling [technology], which is exceedingly fast, very robust, and very small," McKinley said. The technology features an "electric-conducting polymer," or ECP, that enables the rapid thermal cycling; as well as proprietary sample prep technology.
"We've built and invented our own technologies so we don't have to rely on licensing technology a lot of the time," McKinley said. "We've made the instrument as accurate as central reference laboratory equipment; and made it as cheap and easy to use as possible, which is a key for what we see as an emerging market of decentralized locations."
Enigma hopes to launch the ML in Europe in Q4 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.
Enigma and GSK began a clinical trial involving working prototypes of the ML system with European health care providers commenced in the fourth quarter of last year. When GSK and Enigma announced their agreement last July, they said that the launch of Enigma ML was anticipated in early 2011, but apparently that timeline has been pushed up.
Because of the planned European launch, Enigma's decision to ally with Tecan was strongly influenced by Tecan's extensive European presence, McKinley said.
"We've been looking for some time for a company with global capabilities; with a high reputation for medical instrumentation; and that would be within the European arena, because we're officially launching the instrument in Europe with GSK," McKinley said.
"This agreement was also made because of their global reach," McKinley added. "We talked to one or two other companies, but we came to an agreement with Tecan."
Tecan, based in Mannedorf, Switzerland, has additional locations throughout Europe, including in the UK; as well as the East and West coasts of the US; China; and Japan.
"We are excited to be partnering with such an innovative company as Enigma," Tecan CEO Thomas Bachmann said in a statement. "We are highly committed to contributing to the success of the wide range of potential applications and tests the ML platform offers with our experience in manufacturing and servicing high-quality and regulatory compliant diagnostic products."
McKinley also said that Tecan has a "strong network for technical support in various countries, particularly in Europe. We don't have an agreement there yet, but certainly in the future we'll be talking with them about technical training and support for the instrument, because they have that capability."
Before Enigma can launch its platform in Europe it must obtain CE Mark authorization, which it is currently pursuing alongside GSK. In the meantime, the company is developing assay content to run on the system and complement the influenza diagnostic.
"We're certainly looking at the [sexually transmitted disease] market, including chlamydia and gonorrhea; and because we have the flu pandemic assay, we're looking at other respiratory assays, as well," McKinley said. "Those would be our initial targets."
Following a European launch, Enigma will eventually seek US Food and Drug Administration approval and a CLIA waiver in the US, denoting the lowest level of instrument complexity and allowing the platform to be used across all decentralized diagnostic markets.
However, McKinley said that Enigma hasn't started on that process yet.
"We'll concentrate on Europe first and then we'll work with GSK to decide what other countries to move into next," McKinley said. "It could be the US, or it could be others."