FDA Approves Screening Tests

According to CDC, approximately 40 to 100 new cases of Severe Combined Immunodeficiency or (SCID) are identified in newborns in the U.S. each year. SCID is a group of disorders caused by defects in genes involved in the development and function of T cells and other infection-fighting immune cells.

Babies with SCID appear normal at birth but typically develop life threatening infections within a few months. Without early intervention and treatment, death can occur within the baby’s first year but with early detection and treatment, chances for survival greatly improve.

The FDA now allows marketing for the newborn screening test called the “EnLite Neonatal TREC Kit” to help detect SCID. The Kit is manufactured by PerkinElmer www.perkinelmer.com at their facility in Turku, Finland with PerkinElmer based in Waltham Massachusetts.

Using a few drops of blood taken from the newborn’s heel which is dried on filter paper, the 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. Additional testing is required to obtain a SCID diagnosis.

FDA reviewed a clinical study of about 6,400 blood spot specimens from routine screening of newborns, where the Kit correctly identified 17 SCID cases. However, the Kit is not intended to screen for SCID-like syndromes, such as DiGeorge Syndrome or Omenn Syndrome

FDA also cleared a screening test to help predict the risk of Coronary Heart Disease (CHD). The “PLAC Test” is manufactured by diaDexus, Inc. www.diadexus.com based in South San Francisco, The test is able to measure Lp-PLA2 in a patient’s blood which is important since Lp-PLA2 is a biological marker for vascular inflammation, a condition associated with the buildup of plaque in the arteries.

Researchers performed the test on 4,598 participants ranging in age from 45 to 92 with no history of CHD. Researchers followed the participants for several years and recorded the individuals that experienced a CHD-related event.

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