The firm has been placing point-of-care systems primarily in the private sector, but may have increased access once it completes WHO prequalification review.
The research team has founded a startup called Ampera Life to commercialize the technology to detect genetic mutations and infectious agents in patients.
The assay detects a mutation that can confer hearing loss in patients, particularly neonates, who have taken gentamicin, an antibiotic prescribed for certain bacterial infections.
The newly independent firm will continue to invest in diagnostics by bringing its menu of PCR tests for infectious diseases to the US and other markets, among other objectives.
Irish rare disease research center FutureNeuro is partnering with software vendor Congenica to bring sequencing to the point of care for genetic epilepsies.
The Fraunhofer USA team will partner with a Fraunhofer Society institute in Germany in order to reduce the cost for its patented microchip that detects viruses including Ebola.
Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.
