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The test would also be used to detect antibiotic susceptibility. Fraunhofer received £900,000 from SBRI Healthcare in support of the project to develop the test.
The device consists of a reservoir that enables the analyte to contact only the top of a screen-printed electrode, increasing sensitivity.
According to CEO Eugene Chan, the CE designation is just the first of more to come, as the company enters the diagnostics market with a focus on hematological testing.
The company offers the FDA-cleared Trak Male Fertility Testing System, an at-home test that allows men to learn more about their sperm count level.
The Alameda, California-based startup will use the funding to advance the commercialization of its rapid diagnostic platform for infectious diseases.
Given the high yield of miRNA markers they were able to isolate, the researchers believe the approach could be commercialized for routine cancer testing.
The firm will begin initial trials for antibiotic-resistant urinary tract infection detection in UK hospitals in early 2018.
Researchers at NJIT have initially tested their biochip for the detection of early-stage ovarian cancer, but they said it could have use for other cancers and diseases.
By pressing on a piece of paper, a user could power up the test and potentially apply it in a remote location, the researchers said.
Ascendas will develop and commercialize molecular diagnostic systems and assays using certain of Fluidigm's microfluidic technologies.