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Epistem Betting BD Distribution Deal for POC TB Test Will Spur Interest in Genedrive Platform

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UK-based molecular diagnostics developer Epistem said this week that Becton Dickinson will distribute Epistem's point-of-care assay for Mycobacterium tuberculosis and rifampin resistance on a global basis excluding India and the Indian sub-continent.

The agreement is a boon for Epistem's efforts to broadly commercialize its first molecular test and its Genedrive system, a rapid, handheld, point-of-care molecular testing platform for which the company is developing assays in a number of markets including infectious disease testing and pharmacogenomics, Epistem CEO Matthew Walls told PCR Insider this week.

The agreement may also provide resource-poor areas of the world with a truly inexpensive, point-of-care test for TB and drug-resistant TB, as Epistem has claimed that Genedrive can be manufactured at a cost of around $400 and its consumable test cartridge manufactured for about $0.50.

Under the terms of its agreement with BD, Manchester, UK-based Epistem said that it will receive an upfront payment of $1 million and further milestone payments up to $3 million. In addition, the agreement includes escalating supply volumes over the next five years.

The agreement excludes India and the Indian sub-continent because Epistem already has in place an agreement with India's Xcelris Labs to market the Genedrive TB test in those areas (PCR Insider, 6/30/2011). The Genedrive TB test received the CE-IVD Mark in July, allowing Epistem the ability to market it in certain European, African, and Middle Eastern countries. The company hopes to achieve regulatory clearance in India by the end of the year so it can move forward with Xcelrys there, Walls said.

"[Xcelrys] is much more local, and has a network across India," Walls said. "The BD piece is obviously more global. They're a long way ahead of most groups in terms of TB testing in general, [in terms of culture-based] methods and so on. It makes a lot of sense for us … to work with them on a molecular basis. Epistem [has a lot of experience] developing the next generation of [molecular diagnostic technologies] … but what we don't have is the distribution team in place to exploit that properly. BD [does]."

BD markets a number of traditional TB diagnostic products, including the BACTEC MGIT (Mycobacteria Growth Indicator Tube) 320 and 960 Systems, but does not currently offer any molecular testing solutions. The extent of its marketing and distribution network for TB testing is unclear.

Epistem unveiled Genedrive in early 2011 when it said that it had begun collaborating with undisclosed clinical labs and companies in the UK and US to beta test the platform, a fully integrated, endpoint PCR-based system that weighs just over one pound and has a footprint similar to that of a tablet computer (PCR Insider, 4/7/2011).

Genedrive features push-button operation and integrated data analysis, and uses a thin-walled consumable cartridge and fast thermal cycling technology that can perform about 30 PCR cycles in as little as 17 minutes.

Epistem's TB assay currently tests for the presence of M. tuberculosis and rifampin-resistant strains of the bacterium, which has been deemed an adequate surrogate for multi-drug and extreme drug-resistant strains. "Those are the two we're starting with, but then we'll move on over time to extend the scope of that," Walls said.

Numerous other companies have developed or are developing automated benchtop or point-of-care molecular testing devices. However, for TB testing, in particular, comparisons to Cepheid's Xpert MTB/RIF — which the World Health Organization has endorsed for use and which is currently widely deployed in resource-poor areas of the world — are inevitable.

"Certainly we're aware of Cepheid … [which has] a bit more of a traditional … bigger system," Walls said. "It's about the size of a photocopier or a small printer; whereas Genedrive is a bit bigger than an iPod and a little bit smaller than an iPad. You can pop ours in your satchel, plug it into to your car battery and take it into a remote location in a developing nation and run a test. So it lends itself to a completely different approach to point-of-care diagnostics."

In addition, Walls noted, Genedrive can run a full sample-to-answer assay in about 30 to 40 minutes, whereas the Xpert test takes about 90 minutes. "Each one of these is a point of difference, and we're not the same as where Cepheid is," Walls said.

The fact that BD will market the Genedrive TB test in resource-poor areas of the world also raises a discussion about test cost — an issue that Cepheid has been dealing with since it introduced Xpert MTB/RIF. Just this week, Cepheid announced that it had signed the first in a series of agreements with various government agencies and non-profit organizations to buy down the price of Cepheid's Xpert MTB/RIF test — from $16.98 to $9.98 per test cartridge — in an effort to drive widespread adoption of the assay (see story, this issue).

Walls previously told PCR Insider that the company expects to be able to manufacture an instrument for about $400 and a consumable cartridge for about $0.50. This week, he said that the company "hasn't changed our view, it still stands where we were. Suffice to say, we're building a technology that we see having … a competitive advantage for the future. And as we go into market with our first test and subsequent tests, we'll obviously need to take into consideration where everyone is, and the players, and what the environment is."

However, he declined to comment on potential pricing of the TB assay, or even if it would be priced lower than Cepheid's test, instead deferring to BD. A spokesperson for BD declined to comment, noting in an e-mail that BD "is pleased to confirm a distribution agreement with Epistem" but "since the product is in development, we can't disclose additional details at this time."

Although Epistem's near-term focus will be on commercializing the Genedrive TB test, it has under development several other tests for its platform.

"On the infectious disease side we're thinking about … the STDs, so chlamydia, gonorrhea, herpes, HIV; but also Dengue fever," Walls said. "We haven't done a lot on malaria but I suspect that will come into the pack at some point. And then moving across into the pharmacogenomic and oncology area … we have work going on with things like EGFR, JAK2, KRAS. The application is different here, because … it's a small handheld unit, and people will say that a traditional centralized lab can still operate in that environment. But we think it will change the way people think about testing, both because of the price point and the true point-of-care use of testing."

Epistem will likely pursue CE-IVD Marking and not US Food and Drug Administration approval for the majority of these assays as they come down the pike, because the company doesn't currently have "significant bandwidth to run through lots of regulatory processes," Walls said. However, he noted that influenza testing is a market that the company might consider tackling in the US.

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