Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation SensiGene fetal RHD genotyping. Lansdale: HAYES, Inc.. Genetic Testing Publication. 2013 Authors' conclusions When RhD-negative women become pregnant, they are at risk of becoming sensitized to D antigen if the fetus they are carrying is RhD-positive. In subsequent pregnancies, there is a risk of HDN if maternal anti-D crosses the placenta and binds to RhD-positive RBCs. In nonsensitized RhD-negative pregnancies, where the mother has an RhD-positive partner and therefore is at risk of carrying an RhD-positive fetus, it is standard to administer prophylactic anti-D immunoglobulin at 28 to 30 weeks to prevent formation of antibodies to D antigen. This treatment is unnecessary in the approximately 40% of pregnancies with an RhD-negative mother and RhD-positive father because the fetus is also RhD-negative. In sensitized RhD-negative women, intensive monitoring for fetal anemia is necessary in cases where fetal RhD status is unknown. Fetal RhD status may also influence decision making regarding the procedure used for invasive prenatal diagnosis. In an effort to avoid unnecessary prophylactic treatment and help guide treatment decision making for invasive procedures, prenatal RHD genotyping may be performed to ascertain fetal RhD status. Fetal genotyping may be performed by invasive methods such as chorionic villus sampling (CVS) or amniocentesis; however, these procedures carry inherent risks of fetal damage or miscarriage, or of sensitization in the case of an RhD-negative mother/RhD-positive fetus. A noninvasive method of genotyping is therefore desirable. Since the discovery of the presence of cell-free fetal DNA (cffDNA) in maternal plasma, efforts have been made to develop noninvasive testing methods of fetal genotyping utilizing cffDNA. The SensiGene Fetal RHD Genotyping Test is a noninvasive fetal testing method that utilizes the Sequenom Center for Molecular Medicine (Sequenom CMM) proprietary cffDNA detection and analytical methodologies. Indexing Status Subject indexing assigned by CRD MeSH Fetus; Genotypes; Genotyping Techniques; Prenatal Diagnosis Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218 Email: hayesinfo@hayesinc.com AccessionNumber 32014000330 Date abstract record published 05/02/2014 |