PerkinElmer, a global leader focused on improving the health and safety of people and the environment, announced the first commercially available screening test in the US and Canada for Severe Combined Immunodeficiency (SCID), also known more commonly as “Bubble Boy” disease.
PerkinElmer has received market authorization from the FDA and from Health Canada to offer the VICTOR EnLite and EnLite Neonatal TREC Kit.
Since 2013, PerkinElmer’s SCID screening test has been available for sale in select countries in Europe and the Middle East, introduced under CE marking. With the approval of this test in the U.S. and Canada, PerkinElmer now provides SCID screening in more than 30 countries worldwide.
"We are pleased to offer access to our SCID screening test throughout a wide range of geographies globally to help ensure that laboratories can screen newborns with the most advanced testing products available for improving the health of babies," said Prahlad Singh, President, Diagnostics, PerkinElmer.
"As a global market leader in newborn screening for more than 25 years, we are committed to continually expanding our panel of tests for life threatening conditions and helping customers obtain clinically actionable insights for improved medical outcomes."
"Implementing newborn screening for SCID provides a cost benefit compared to the greater costs of managing the condition when detected later," said Fred Lorey, Ph.D., newborn screening consultant and member of the HHS Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children.
Screening with PerkinElmer’s VICTOR EnLite and EnLite Neonatal TREC Kit is intended to provide an effective, semi-quantitative determination of T-cell receptor excision circle (TREC), a circular DNA structure which is the primary identifiable marker for SCID.