By Ben Butkus
Epistem, a UK-based biotechnology and personalized medicine firm, has begun collaborating with undisclosed clinical labs and companies in the UK and US to beta test GeneDrive, its PCR-based, point-of-care molecular diagnostic platform, the company said last week.
Epistem will initially target sexually transmitted disease testing in remote areas and companion diagnostic development with GeneDrive, but it is also developing assays for a range of other infectious diseases and oncology testing, according to CEO Matthew Walls.
And with a current manufacturing cost of about $400 per instrument and $0.50 per consumable cartridge, a test turnaround time of about 25 minutes, and comparable performance to existing molecular testing platforms, GeneDrive will be "very disruptive to the PCR industry," Walls said.
"It's being produced at a very low cost, almost at the consumable level, with high-end [specifications]," Walls told PCR Insider. "At the moment, I don't think anyone comes in at the level of our cost and turnaround time, which lends itself to a change in the way we deliver healthcare."
Traditionally a player in stem cell therapeutics, biomarker discovery, and contract research, EpiStem began developing GeneDrive almost five years ago, but has only in recent months begun discussing the platform publicly.
The company has not yet provided a firm commercialization timeline for GeneDrive. However, Epistem noted in its recently released 2010 financial results that it has commenced beta testing GeneDrive STD assays in certain UK genitourinary clinics; and has begun discussions with industry players that might help the company market GeneDrive and generate initial evaluation-based revenues in the second half of this year.
"As a company, we like to get things developed to a pretty advanced stage before we start talking about them," Walls said. "But we can talk about it a little bit more easily now, partly because we're in discussions with a number of groups, and because it's in beta testing here in the UK."
In addition, Walls said that Epistem this month has been in discussions with various potential clinical testing sites in the US, specifically in Southern California.
"We've also done some testing in the US in terms of benchmarking with some Roche and other molecular assays," Walls said. "You can potentially use other assay systems on [GeneDrive], but it's primarily built for our own assays that we've put together in house. And we've done our internal testing and comparisons to other systems on the market."
The current version of GeneDrive is a fully integrated, endpoint PCR-based platform weighing just over 1 lb., with a footprint "a little bigger than an iPod, and a little smaller than an iPad," Walls said. Push-button operation and integrated data analysis make the platform ideal for use by relatively unskilled technicians, the company said.
The system is used with a thin-walled consumable cartridge onto which all reagents and sample are loaded for subsequent analysis; and thermal cycling occurs via GeneDrive's so-called "hybrid thermal engine," which is capable of performing ultra-fast PCR cycling of about 30 cycles in as little as 17 minutes.
Compared with many existing thermal cycling technologies based on Peltier or thermal block heating, GeneDrive's faster cooling rates and shorter annealing times provide precise primer-template pairing, leading to a higher specificity of the amplicon and an overall improvement in product quality, according to the company.
Other technical specs include dual ARM processors, an LCD display, internal real-time clock, and a mini USB. The system can run on a 12-volt DC battery, making it suitable for remote operation.
EpiStem said that its internal tests have shown that the system has at least comparable performance to many of the market-leading molecular testing platforms, including Cepheid's GeneXpert, Bio-Rad's CFX96, Qiagen's Rotor-Gene Q, and Roche's LightCycler 480 – "but of course those are higher-end systems at a much higher cost," Walls said.
In terms of system integration, GeneDrive is probably most similar to Cepheid's GeneXpert, which provides sample-prep capabilities on its consumable cartridges, something that GeneDrive does not. For GeneDrive, sample prep is done "beforehand in the main lab," Walls said. He added that the company has designed its sample-prep protocols mostly for whole-blood samples thus far, but that the sample prep "is really specific to the disease area we're looking at."
In addition, GeneDrive is not a real-time quantitative PCR platform, and as such would provide qualitative as opposed to quantitative results at the point of care.
Nevertheless, EpiStem is betting that GeneDrive's cost and speed advantages will outweigh any drawbacks. "It's a broad-based diagnostic device … not linked to one diagnostic area; it's at a cost that is unheard of in this sector; and the chemistries we've put together on the assay side are all proprietary and unique to us, and we've got a strong IP position around both the unit and the assays," Walls said.
The company's assay technology, called iD probes, uses a proprietary chemistry that provides "robust melt-curve parametrics for complex genotyping information" and enables "single-probe multiplexing of multiple sequence variants and closely related sequences," the company said.
GeneDrive's first stable of assays, the subject of ongoing beta testing, include tests for STDs such as chlamydia, herpes, and gonorrhea. In addition, in the oncology area, the company is developing molecular assays for mutations in genes such as KRAS, BRAF, and EGFR.
"If you look at the next generation or current generation of drugs coming onto the market, where you have to test a patient for predisposition to a certain mutation before you administer the drug … GeneDrive lends itself to going hand-in-hand with the drug development," Walls said.
"It's such a low price that the drug regime … would cost significantly more than the cost of a diagnostic, so you can kind of bundle them together," he added.
Epistem has already made progress toward this goal: As reported two weeks ago by PCR Insider sister publication PGx Reporter, Epistem recently signed a three-year collaboration with Sanofi-Aventis to use its biomarker discovery technology in Sanofi's oncology programs.
And although that collaboration will use a different Epistem technology – namely, the company's proprietary gene expression platform, called GenetRx, and its RNA-Amp technology – Walls told PGx Reporter that the GeneDrive platform would likely find its way into the mix.
In general, Epistem hopes to eventually land multiple pharma customers for whom it can develop custom GeneDrive molecular tests.
"It's going to move, over time, to a point-of-care position, on the front end of molecular screening and diagnosis," Walls said. "That's where we want to position it, but it will take some time to get there. So in the short term it's being positioned more for remote patient diagnostic use, and also for companion diagnostic use for pharma groups."
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