NEW YORK (GenomeWeb) – Initially planned for a 2011 launch, Atlas Genetics' multiplex, molecular diagnostics system, called io, will hit the market four years later if the company is successful in launching it this year.
But as the firm's CEO tells it, the delay did not result from any technical failures or quality issues. Rather, it stemmed from a decision by Atlas to add automation capabilities to the platform that has now increased its multiplexing capabilities and will allow Atlas to better predict its costs when io goes live.
"Having looked carefully at the market, we decided that it would be sensible to invest up front in automating certain parts of the [cartridge] assembly process," Atlas CEO John Clarkson told GenomeWeb recently. "That has taken time to put in place. So it was our decision to invest more heavily in that area … to prove conclusively the ability to be able to manufacture these cartridges in higher volume … and that was a more sophisticated manufacturing strategy than we had originally anticipated."
Fresh off a Series C financing round that brought in $20 million, Trowbridge, UK-based Atlas expects to start a clinical trial in Europe for its chlamydia assay in the second quarter of this year. It anticipates launching that assay and the io system later in the year in Europe, both with CE marking.
Afterward, it anticipates a clinical study in the US for a chlamydia/gonorrhea test in Q2 2016, ahead of a filing for 510(k) clearance from the US Food and Drug Administration. That would potentially be followed by a launch of that test and the system in the US.
Founded in 2005 as a spinout of the University of Bath and Osmetech, now called GenMark Diagnostics, to commercialize technology developed at the university, Atlas has spent much of its time since 2011 automating its cartridge manufacturing process. The result is "a higher volume capability now, and that volume is scalable, so we know what will be required to increase the production of cartridges," Clarkson said. He added that another "critical" benefit of the change in manufacturing strategy is that Atlas can now "predict very accurately what the cost of goods will be … what our cartridge cost will be at various volumes."
The io is a molecular point-of-care platform that uses an electrochemical detection technology developed at the University of Bath for highly sensitive, multiplexed nucleic acid amplification and immunoassay tests. The technology is based on differential pulse voltammetry — bacteria or viruses from a sample are lysed, and DNA is extracted, purified, and chemically dissociated in preparation for amplification. PCR amplification of a specific target sequence produces a single–stranded DNA product, to which a target-specific electrochemically labeled probe is hybridized.
The io platform can deliver test results in less than 30 minutes and is designed for decentralized environments. As a result, its main customers would include those working in specialist healthcare settings, such as clinics for sexually transmitted diseases and family planning settings, as well as those in primary care settings, Clarkson said.
He acknowledged that as a VC-backed firm with "very limited revenues," there is a sense of urgency to get io to market. But with the additional investments, io will be a better technology when it is launched.
"It's very easy to make small numbers of cartridges for molecular diagnostics," he said. "The challenge is to be able to make them reproducibly in higher volumes, and we decided we would take that challenge on earlier than we had originally anticipated that we would do," Clarkson said.
He added that the delay has meant that Atlas was able to build out its test capabilities, noting its chlamydia/gonorrhea assay now has more internal controls and genomic targets for the pathogens than had been originally planned. The assay now has two internal controls, one genetic marker for chlamydia and two genetic markers for gonorrhea.
He told GenomeWeb that the company has met with FDA, and "we feel very comfortable" with the structure of the clinical trial for chlamydia/gonorrhea" that Atlas will conduct for the assay. In addition to seeking 510(k) clearance for the assay and the io platform, Atlas plans to pursue CLIA waivers, Clarkson said.
Before launching the chlamydia/gonorrhea test in the US, though, Atlas is in the midst of preparing for a clinical trial of its chlamydia assay. Clarkson declined to elaborate about the trial, but said that up to 2,000 patients will be recruited for it, and that Atlas is in discussions with regulators about the structure of the trial.
Clarkson also declined to specify which European countries it will target for the launch of the chlamydia assay, though he identified the UK as an important market. Atlas plans to market the test to clinics specializing in sexually transmitted diseases and hospitals, specifically small- to mid-sized hospitals. Atlas' commercialization plans call for a combination of direct sales and distributors, he said.
Other assays in Atlas' pipeline include those for sexually transmitted diseases, hospital-acquired infections, respiratory viral infections, and sepsis. Atlas anticipates commercializing the STD and HAI tests during "the next couple of years," Clarkson said, while respiratory viral infections and sepsis represent longer-term opportunities.
Clarkson said that a key investment by the company has been in the area of multiplexing and each of io's cartridges can now run 24 tests from one patient sample. "It is that increased multiplex capability that is now taking us into the sepsis and respiratory areas as opportunities," he said.
In addition, the firm previously said that it is developing a MRSA assay, which has been through a preliminary clinical evaluation and will be launched after the chlamydia and chlamydia/gonorrhea tests.
Lastly, Clarkson said that Atlas is "actively involved in a number of companion diagnostic programs" that are outside of the infectious disease market, though he declined to elaborate. He said that Atlas has created a CDx program within the company and is developing such tests but would not comment on possible development partners.