FDA Gives Green Light To PerkinElmer's Screening Test For SCID

(RTTNews) - PerkinElmer Inc.'s (PKI) EnLite Neonatal TREC Kit has received FDA clearance, thus becoming the first screening test permitted to be marketed by the U.S. regulatory agency for Severe Combined Immunodeficiency in newborns.

Severe Combined Immune Deficiency or SCID (pronounced skid) is a group of inherited disorders involving T and B lymphocytes, making them vulnerable to a variety of recurrent severe infections. According to the Centers for Disease Control and Prevention, approximately 40 to100 new cases of SCID are identified in newborns in the United States each year.

Measuring TRECs (T-cell Receptor Excision circles) in DNA extracted from dried blood spot samples of newborns is a method for screening infants for SCID. In healthy infants, the TRECs are made in large numbers, while in infants with SCID, they are barely detectable. Therefore the TREC is a biological marker of SCID.

The EnLite Neonatal TREC assay is a dried blood spot (DBS) assay but does not involve DNA extraction and transfer of samples. Screening through the EnLite Neonatal TREC System is intended to provide accurate results and minimize the number of steps taken towards a SCID diagnosis.

Using a few drops of blood taken from the newborn's heel, which is dried on filter paper, the EnLite Neonatal TREC Kit can determine whether a certain type of DNA, known as T-cell receptor excision circles (TREC DNA), is low or missing from the newborn's blood, the FDA noted in a statement.

The EnLite Neonatal TREC System received CE Mark approval last August and is already available in Europe and the Middle East.

PKI closed Monday's trading at $41.41, down 0.77%.