NEW YORK (GenomeWeb) – Atlas Genetics announced today it has received CE-IVD marking for its Chlamydia trachomatis test and io ultra-rapid point-of-care platform.
Evaluations of the test, which takes about 30 minutes to perform, demonstrated performance equivalent to a gold standard lab-based test, and the firm found results were not compromised by transitioning to POC or by the operator's level of experience, it said.
"STIs are on the rise and the faster a diagnosis can be made, the faster treatment can be given, not only benefiting the patient but also saving time and money," noted John Clarkson, CEO of Atlas Genetics. "We believe that our io platform will play a key role in the future of STI diagnosis," he said.
The io platform uses electrochemical detection technology to perform multiplexed nucleic acid amplification tests and immunoassays. Tests in Atlas' pipeline, including ones for gonorrhea and Trichomonas vaginalis, exemplify an initial focus on STIs, but the platform lends itself to other infectious disease assays and oncology molecular diagnostic tests, the firm said.
Atlas told GenomeWeb last year that the company had met with FDA, and will seek 510(k) clearance for the assay and the io platform, as well as CLIA waiver.
US Preventative Services Task Force guidelines for chlamydia and gonorrhea testing were updated in 2014 and now unequivocally endorse the use of molecular diagnostics. At that time, experts told GenomeWeb that a POC test would be a "game changer" for public health.
In the near-patient and POC space, Cepheid has a CT/NG test on its GeneXpert system, has announced intentions to focus on the CLIA-waived market, and will be adapting its test for the POC Omni platform ex-US in 2017, and in the US in 2019-20. Alere is developing a gonorrhea/chlamydia assay for the Alere i platform, while Meridian Bioscience has developed chlamydia and gonorrhea targets for its Illumigene platform, which also has an FDA-cleared HSV 1&2 assay. Quidel, meanwhile, has an HSV 1&2 test as well as a Trichomonas vaginalis assay on its POC AmpliVue platform.