By Diagnostics World Staff
February 17, 2016 | Atlas Genetics, a point-of-care infectious disease diagnostics company based in Trowbridge, UK, and Boston, Mass., has received its first regulatory approval, a CE Mark for a chlamydia test that will now be available for sale in Europe. The test is designed for Atlas’ io Reader instrument, a benchtop device with a touchscreen interface that performs tests automatically after a patient sample is inserted in a disposable cartridge.
The io technology is based on the detection of short, pathogen-specific DNA sequences, by measuring electrical signals released after labeled DNA probes bind to genetic material in the sample. In order to run these reactions on a single cartridge, Atlas has designed a staged microfluidics system in which cells are lysed, DNA is immobilized, polymerase chain reaction amplifies the sample DNA, and finally a solution of probes is added that will create an electrical signal if pathogen DNA is present. Reagents are preloaded on cartridges, so tests can be run in 30 minutes using just the io Reader.
Atlas Genetics was founded in 2005 as a spinout from the University of Bath. In 2010, the company presented initial data on its system that executives said would pave the way for a commercial launch before the end of 2011; however, there were numerous delays preparing a final product for regulatory submissions. The chlamydia test that can now be sold in Europe is the simplest version of Atlas’ technology, where only a single disease is diagnosed per cartridge―because amplified DNA can be divided into four microfluidic chambers, and each chamber can accommodate several different electrochemical probes, the system is designed to eventually run highly multiplexed tests. One cartridge in development simultaneously targets the sexually transmitted pathogens Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.
In the coming year, Atlas plans to submit additional tests to European regulators, as well as to the US FDA. Because the io Reader is almost entirely automated, the company hopes to eventually receive CLIA waivers for its tests, for use by non-specialists in hospitals and small clinics.