Overview

NTD Labs holds numerous patents for innovative technologies in prenatal screening. Its achievements in first trimester screening include the First Trimester Screen | Fß protocol for Down syndrome risk assessment which often provides the reassurance patients hope to receive in the first trimester of pregnancy.

Unique in many ways, the First Trimester Screen | Fß protocol utilizes biophysical data as well as biochemical markers to reliably assess a patient’s risk for having a fetus with Down syndrome and trisomy 18 and 13. Performed between 11 weeks, 1 day and 13 weeks, 6 days gestation, the protocol uses analytical data from an advanced immunoassay blood screen (derived from dried blood spot or venous sampling) and data from a nuchal translucency (NT) ultrasound examination, combining both the biochemical and biophysical markers to produce the risk assessment.

The maternal blood sample is analyzed for the 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 the 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 at a 5% false positive rate for Down syndrome and a 95% detection at a 0.3% false positive rate for trisomy 18 and 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 13,25,26)

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 Assessment 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, a global technology company with expertise 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 at the forefront of research and innovation in genetic science.