The regulatory approval has been granted for the kit to be used as an in vitro diagnostic (IVD) by certified labs to detect SMA and severe combined immunodeficiency (SCID) in newborns at the same time.
PerkinElmer claims that EONIS is the first assay to receive FDA approval to screen SMA in newborns in the US.
It is part of the company’s EONIS Platform, a robust, flexible system that uses real-time polymerase chain reaction (PCR) technology to screen SMA and SCID from a single dried blood spot sample.
The system combines DNA extraction and multiplexing and facilitates maximum automation and efficiency in the workflow when it is combined with the PerkinElmer JANUS liquid handler.
EONIS Analysis Software and EONIS DNA Extraction kit are the other components of the EONIS platform.
PerkinElmer reproductive health general manager Petra Furu said: “For nearly three decades, PerkinElmer has delivered innovative solutions to laboratories and clinicians worldwide that help diagnose newborns with rare diseases and inherited disorders.
“This authorisation is a major milestone for newborn screening in the United States.
“Labs across the country will be able to access technologies that detect SMA and SCID and provide them the confidence that every test meets regulatory, manufacturing and accreditation requirements.”
The company has already received CE-IVD mark for the EONIS Platform. This allows the platform to be used by certified labs in countries that accept the CE mark.