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Atlas Genetics Aims to Market POC MDx Platform, First Test for Chlamydia, by End of 2014

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Atlas Genetics, a UK-based firm specializing in point-of-care in vitro diagnostics, is aiming to market its first products — a low-cost, ultra-rapid, cartridge-based testing system and associated nucleic acid test for Chlamydia trachomatis — with CE marking by the end of 2014, a company representative said recently.

Soon thereafter, Atlas aims to then commercialize a combined chlamydia/gonorrhea molecular assay both in Europe and the US, followed by tests for Trichomonas vaginalis, herpes simplex virus, syphilis, and HIV.

The company has delayed the commercialization timeline for its platform, called the Atlas io, by almost three years. However, Atlas is betting that its system, once commercialized, will stand out in the rapidly crowding POC diagnostics market because it features a proprietary electrochemical detection technology that will enable highly sensitive, multiplexed nucleic acid amplification tests and immunoassays to be performed in less than 30 minutes from sample to result.

Atlas also hopes to compete on ease of use, and will at first target a moderately complex designation for its platform in the US under the Clinical Laboratory Improvement Amendments, with the ultimate goal of obtaining a CLIA waiver.

Atlas was founded in 2005 as a spinout from the University of Bath and molecular diagnostics shop Osmetech, which has since become GenMark Diagnostics. According to David Pearce, a research manager at Atlas, the company's goal from its inception has been to commercialize infectious disease diagnostics using an electrochemical detection method developed by University of Bath researchers.

The proprietary electrochemical detection method is based on a phenomenon called differential pulse voltammetry, and is similar to the technology used in blood glucose monitoring.

Briefly, bacteria or viruses from a sample are lysed, and DNA is extracted, purified, and chemically disassociated in preparation for amplification. Then, PCR amplification of a specific target sequence produces a single-stranded DNA product, to which a target-specific electrochemically labeled probe is hybridized.

A double-stranded DNA-specific nuclease enzyme then digests the target DNA/probe complex, thus releasing individual nucleotides, including the terminal nucleotide with the attached electrochemical label. Then, a voltage is applied to an electrode, oxidizing the electrochemical label and releasing electrons that are detected as current at the electrode surface.

The current is measured at a specific voltage that correlates with the redox potential of the electrochemical label used, ultimately enabling rapid detection of specific gene sequences with sensitivity down to single-copy levels, according to the company.

Atlas scientists and engineers integrated the technology into microfluidic cards that also contained a sample prep scheme and could be run on a benchtop instrument called, at the time, Velox. In 2010, at a scientific meeting, a company executive presented the platform and told attendees that it expected the platform and first test, for chlamydia, to launch in Europe in 2011.

The platform, however, has required significant fine tuning, thus delaying its commercialization.

Last month, at Cambridge Healthtech Institute's Molecular Medicine Tri-Conference in San Francisco, Pearce presented a poster detailing the latest iteration of the system, now called the Atlas io.

Although Pearce did not provide details regarding why the platform's development has been delayed, he noted that the company has made strides in integrating sample prep into the disposable test cartridges and designing the io instrument for ease of use.

"All the sample prep reagents are on [the cartridge]," Pearce said. 'For DNA extraction, there are wet reagents, and it is boom chemistry. But for the amplification detection, they are all dried reagents that are wet sequentially, so the extracted DNA rehydrates the amplification reagents and, following PCR, that gets pushed through to detection."

For something like the company's first test, for chlamydia, "it's going to be as simple as a self-collected vaginal swab for women; and for men, a urine sample," Pearce said. "They would provide that sample [to the physician], who would use a fixed-volume pipette to transfer it into the card, which they would then put into the machine and press go."

Currently, Pearce noted, the system enables electrochemical detection of three targets in a single detection chamber across a wide range of target concentrations. The company expects that the cartridges will enable a higher degree of multiplexing — possibly up to 20 targets — through the development of additional electrochemical labels, and by designing future cartridges that will divide a sample through multiple channels.

One of Atlas' key collaborators to date has been the laboratory of Charlotte Gaydos, a Johns Hopkins University researcher who specializes in POC diagnostics for STDs. In 2011, Gaydos, Pearce, and colleagues published a paper in IEEE Transactions on Biomedical Engineering validating the Atlas platform, still named Velox at that point.

Specifically, they demonstrated that the system had a sensitivity of 98.1 percent and specificity of 98 percent detecting C. trachomatis from 306 pre-typed clinical samples.

Pearce said that Atlas is still working with Gaydos' lab on a gonorrhea assay validation study, data from which are expected to be published sometime in the coming months.

Chlamydia and gonorrhea remain the company's main focus areas. "Of course, we've also got to finish developing the system," Pearce said. "But the chlamydia assay is our pathfinder assay. We're aiming for … basically an end of 2014 CE Mark. That will then be shortly followed up by dual chlamydia and gonorrhea, both in Europe and in the US, because most [sexually-transmitted infection] testing for chlamydia involves a gonorrhea test in the US."

This will be followed, Pearce added, with tests for Trichomonas and HSV, "and then two immunoassay tests, where we've got interest in syphilis and HIV." Pearce said that this ability to run immune-based tests on Atlas io platform along with molecular tests will help distinguish it in the market.

"The electrochemical methods, we've found, can also be useful on a lateral-flow type assay," he noted.

Atlas also has ongoing work in the area of methicillin-resistant Staphylococcus aureus and group B Streptococcus detection in newborns. The company is also eyeing the veterinary testing market by developing a molecular test for "the strangles," a severe respiratory disease in horses caused by Streptococcus equii.

Pearce said that Atlas is targeting an end-user price of below $33 for its Ct/Ng assay, although "the actual price may vary according to the number of targets and the distributor’s costs," he noted. Meantime, Atlas is targeting a price of less than $15,000 for the Atlas io system.

The privately held company most recently raised £16.9 million ($27.3 million at the time) in a Series B financing in July 2011, led by Novartis Venture Funds and previous investor Consort Medical. Other investors include Life Science Partners, BB Biotech Ventures, and Johnson & Johnson Development.

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