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Overview

NTD Labs holds numerous patents for innovative technologies in prenatal screening. Its achievements in first trimester screening include the Ultra-Screen® protocol for Down syndrome risk assessment which provides the reassurance patients hope to receive in the first trimester.

Unique in many ways, the Ultra-Screen protocol utilizes valuable clinical data as well as biochemical markers to reliably assess a patient’s risk for Down’s syndrome and trisomy 18/13. Performed between 11 weeks, 1 day and 13 weeks, 6 days gestation, the protocol uses accurate analytical data from an advanced immunoassay blood screen (dried blood or venous sampling) and data from a nuchal translucency (NT) ultrasound examination, so there are both biochemistry and biophysical markers involved in the assessment.

The maternal blood sample is analyzed for biochemical markers: free Beta human chorionic gonadotropin (free Beta hCG) and pregnancy associated plasma protein (PAPP-A). The ultrasound exam confirms gestational age and measures fluid accumulation behind the fetus’ neck (nuchal translucency).These combined markers yield the most sensitive screening results possible at the earliest point during the pregnancy with a 91% detection rate and a 5% false positive rate for Down syndrome (95% detection and 0.3% false positive for trisomy 18/13). When a fetal nasal bone assessment is added to the protocol, the detection rate for Down syndrome is increased to 95% and the false positive rate is decreased to 2%. (References)

Other NTD Labs’ milestones include the development of a patented dried blood sampling technique that simplifies specimen collection and handling. NTD Labs also introduced a proprietary Instant Risk AssessmentSM (IRA) program that enables physicians to present a complete risk assessment during a single office visit and also ensure same-day results notification for the patient.

Today, NTD Labs provides first and second trimester prenatal screening services to universities, medical centers, hospitals, laboratories, obstetricians and maternal fetal medicine (MFM) specialists worldwide through an accredited facility owned and operated by PerkinElmer, Inc., a world-class technology company in health sciences and a leader in prenatal and newborn screening. With an unwavering commitment to quality, combined with industry-leading best practices, NTD Labs remains on the forefront of research and innovation in genetic science.