The EONIS SCID-SMA assay kit has been approved by the US regulator for in vitro diagnostic use by certified laboratories
The EONIS SCID-SMA assay kit gets FDA nod for its use in the simultaneous detection of SMA and SCID in newborns. (Credit: PerkinElmer Inc.)
PerkinElmer has secured marketing authorisation from the US Food and Drug Administration (FDA) for its EONIS SCID-SMA assay kit for the simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns.
The US-based testing laboratories company claimed that the assay is the first to be authorised by the FDA for SMA screening in newborns in the US.
The EONIS SCID-SMA assay kit has been approved for in vitro diagnostic (IVD) use by certified laboratories.
According to PerkinElmer, its EONIS Platform is a flexible system that combines DNA extraction and multiplexing to screen both SMA and SCID. It is performed with a single dried blood spot sample by utilising real-time PCR technology.
When combined with the firm’s JANUS liquid handler, PerkinElmer’s workflow enables maximum automation and efficiency and can be tailored to a laboratory’s specific needs and throughput.
The EONIS DNA Extraction kit and EONIS Analysis Software are additional components of the platform, said the testing laboratories company.
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 EONIS Platform is CE-IVD marked for use by accredited laboratories in countries that recognise the CE mark.
In the newborn screening sector, PerkinElmer is said to provide solutions to help identify over 50 congenital disorders.
In September this year, PerkinElmer launched the Cellaca PLX Image Cytometry System for evaluation of multiple critical quality attributes (CQAs) of cell samples, including cell identity, quality and quantity, in a single automated workflow.