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Spartan Bio Aims to Bring POC DNA Testing to Uncharted Waters

By Tony Fong

NEW YORK (GenomeWeb News) – With the recent launch of what it says is the first point-of-care DNA test, Spartan Bioscience is hoping to bring its technology to areas not presently served by molecular diagnostics.

Last week, the Ottawa, Ontario-based company introduced the Spartan Rx CYP2C19 test for identifying a gene mutation that interferes with the metabolism of the anti-coagulant Plavix (clopidogrel). In its announcement, Spartan said the test is the first "complete sample-to-result, point-of-care DNA testing system for personalized medicine."

In an interview with GenomeWeb Daily News, however, Spartan CEO Larry D'Andrea outlined plans by the company for its technology that would encompass not only pharmacogenomic applications, but other uses as well.

Comparing Spartan's technology to the miniaturization of computer technology, D'Andrea said, "I really think our technology is a laptop version of a mainframe computer," where the mainframe computer is analogous to the big instrument systems used in a traditional clinical laboratory. "And once we're at the laptop stage, there are a lot of applications that a laptop can be used for that a mainframe never was."

The PCR-based Rx CYP2C19 test was developed on Spartan's Rx System, a scaled-down version of its Dx12 benchtop instrument and is specifically for Plavix. D'Andrea, however, envisions creating companion diagnostics for other drugs as more genes are identified as biomarkers of non-responsiveness.

"I would suggest that if we go down the road a few years, it's likely that we'll be able to put our device into doctors' offices," D'Andrea said.

Further expanding into the PGx space remains a few years away, he said. In the meantime, Spartan is investigating uses of the technology in other areas, including food and water safety, and environmental testing. The company is also working with partners to use the technology to diagnose infectious diseases, in particular in countries where access to healthcare and instrument platforms is limited. Tests for about 20 diseases are being considered, including HIV, tuberculosis, H1N1, and hepatitis B and C.

Spartan also has "had discussions" with a researcher who has developed a method for determining the sex of cattle from bull semen. A hand-held device based on Spartan's Rx System "can be used as a quality control to determine the percentage of males and females" from a semen sample, D'Andrea said.

For the dairy industry, such a tool could be valuable, he added, because it would offer a way for farmers to breed for cows rather than bulls. Because cows produce milk, they are more highly valued than bulls.

"There's a ton of applications like that that aren't done today that could be done with our device," said D'Andrea who became Spartan's CEO last September. Prior to joining the firm, he led the Canadian M&A practice for business advisors and consulting firm Grant Thornton. He was also a co-founder of Alluence Capital Advisors.

As Spartan explores market opportunities, it also is working on the next generation of the Rx CYP2C19 test to make it smaller and, more importantly, faster. The test currently takes about an hour to get a result. While that improves upon the one to seven days it takes with tests currently done in central labs, the company is exploring the viability of further reducing the time to 10 minutes, which technically is not an insignificant challenge, D'Andrea said.

"It's really a function of being able to heat and cool the thermal cycles within the PCR reaction," he said. "We're starting to challenge how we're actually doing the heating and cooling and there comes a point where …you're hitting the limits of things like the heat transfer through the plastic tube that holds the reagent," he said. "So we may have to re-engineer our tube."

Founded in 2005, Spartan launched its first instrument, called the Dx, two years later. While most of its attention has been on developing its gene testing platforms, D'Andrea said that the company doesn't consider itself a "box manufacturer" but rather a full-solution firm that offers both instruments and tests based on the technology.

The markets the company is targeting, he added, are those who don't already use DNA testing, such as cardiologists, who send tests to be done at a central lab but don't do the testing themselves.

Similarly, in the food and water safety market, inspectors and processors in factory plants currently send samples to a laboratory, but Spartan's goal is to develop a hand-held device that would allow them to do tests on-site. In one project, the company expects to develop a rapid test for listeria, D'Andrea said.

The RX System and the CYP2C19 test for Plavix is currently available for research use only, though Spartan is eyeing eventual regulatory approval that would bring the RX System to the clinic. The system is being used in a clinical trial run by the University of Ottawa Heart Institute to determine whether Effient (prasugrel), an anti-blood clotting drug for CYP2C19 carriers, reduces major adverse cardiovascular events, Spartan said in a statement. The company plans on using the data from the trial when it submits its regulatory applications.

It is also evaluating the possibility of expanding the Plavix test to include more SNPs. The Rx CYP2C19 test right now detects only for the CYP2C19*2 allele found in about 30 percent of the world's population. According to D'Andrea, the allele is responsible for the "vast majority" of non-response to Plavix.

However, the US Food and Drug Administration issued a black box warning on Plavix's label in March saying that in addition to the *2 allele, CYP2C19 *3,*4,*5, *6,*7,*8, and other alleles are associated with poor metabolism of Plavix.

The CYP2C19*1 allele can fully metabolize Plavix.

Generally, LDT tests for Plavix non-response test for multiple alleles.

"Would it be better to have all of them?" D'Andrea asked. "Yeah, but the research isn't all the way up to speed on which of those other ones are really important. We would be developing the other SNPs as the research is coming out."

He said also that a hand-held point-of-care test for multiple drugs or diseases could be foreseeable down the road, but at this point, it's not clear whether a market for such a product exists.

Indeed, getting market adoption of its technology has been challenging for the company, D'Andrea acknowledged. Most of Spartan's efforts have been directed at the infectious disease area, and making inroads has proven more daunting than the company had anticipated, mostly because its technology is "opening a market that didn't really exist before," he said.

Sales of the Dx-12 platform, introduced a year ago, have been slow as finding the right distributors, having them test the device, and then the entire customer buying process has taken longer than Spartan had anticipated.

"What's different for us is the market segment that we're going after," said D'Andrea, "because we're not trying to sell laboratories … We're selling it to people who don't have the microbiology capabilities today."

In Kenya, for example, a blood bank is evaluating Spartan's Dx-12 platform to test for pathogens. The blood bank, he said, currently uses immunoassays for such work, so the PCR-based Dx-12 is brand new technology for it. "They have to satisfy themselves that this new way of doing things is going to be better," D'Andrea said.

The company, which has 18 full-time and part-time employees, has been financed primarily by angel investors, he said, though it has recorded some revenues. He declined to be more specific.

Spartan is also preparing for a Series A funding round, he added.

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