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Prenatal Rh(D) Diagnostic Test Launched

Earlier this month, at the Annual Clinical Meeting of the American College of Obstetrics and Gynecology, Biocept introduced their new diagnostic test (pdf), the I.D.Rh(D). The test is used to diagnose the Rh(D) status of fetus. This is one product in Biocept’s line of prenatal diagnostics which are noninvasive.

The test is completed with a simple blood sample and can be completed as early as ten weeks of gestation. The I.D.Rh(D) test isolates fetal DNA cells that are circulating through the mother’s whole blood using a proprietary technology from Biocept, I.D. (Isolating Fetal DNA).

The test can provide definitive diagnoses amongst all patients who can be diagnosed, regardless of whether the fetus is male or female or Rh(D) positive or negative. Some existing diagnostic approaches cannot distinguish mother from child’s DNA when the fetus is female.

The test is indicated among pregnant women who are Rh(D) negative who have partners who are Rh(D) positive. These women may be carrying babies that are Rh(D) positive. If this is the case, the woman may develop antibodies that attack fetal red blood cells. Problems associated with this immune response include cerebral palsy, fetal anemia, jaundice, mental retardation, and occasionally death.

Currently available approaches to determine Rh(D) status in the U.S. can only be completed with more invasive procedures, for example chorionic villus sampling (CVS) amniocentesis. Both of these tests pose risks to the fetus.

May 12, 2008 Related topics: Product Launches, Diagnostic, Obstetrics, Gynecology & Neonatology

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