SAN DIEGO, May 5 /PRNewswire/ -- Biocept, an emerging leader in biotechnology, will launch I.D. Rh(D), the first in a series of noninvasive prenatal diagnostic tests that can be performed with a simple maternal blood sample, at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, May 3-7 in New Orleans.
The I.D.Rh(D) test diagnoses the Rh(D) status of a fetus in an Rh(D) negative pregnancy, and can be performed as early as ten weeks of gestation. The test isolates fetal DNA circulating in the mother's whole blood, using Biocept's proprietary I.D. (Isolating Fetal DNA) platform technology (U.S. patents pending). The fetal DNA is analyzed in Biocept's CLIA-accredited clinical laboratory to determine Rh(D) genotype. Similar noninvasive tests have been available routinely in some countries outside the US.
Each year, approximately 460,000 Rh(D) negative women in the United States become pregnant. If their partners are Rh(D) positive, which they are in approximately 89% of cases, these women risk carrying a fetus that is also Rh(D) positive. When this occurs, the woman may develop antibodies that attack fetal red blood cells, leading to problems ranging from fetal anemia and jaundice to cerebral palsy, mental retardation, and even death.
Until now, the only tests available to definitively diagnose fetal Rh(D) genotype required invasive procedures such as amniocentesis or chorionic villus sampling (CVS), which carry their own risks to the fetus. For this reason, physicians have routinely administered anti-D immune globulin injections, a human blood product, to all Rh(D) negative women at 28-29 weeks of gestation.
"The I.D.Rh(D) test marks the beginning of a new era in definitive noninvasive prenatal testing," said Joe Leigh Simpson, M.D., Executive Associate Dean for Academic Affairs at Florida International University College of Medicine. "I.D.Rh(D) offers physicians and their patients a noninvasive diagnostic alternative."
I.D.Rh(D) is the only fetal Rh(D) diagnostic that identifies fetal DNA in maternal blood in all cases in which a diagnosis can be delivered-whether the fetus is male or female, Rh(D) negative or positive. This eliminates the uncertainty that can occur with other tests in which an Rh(D) negative female fetus cannot be definitively identified from the maternal blood sample.
"We believe I.D.Rh(D) represents a personalized approach to patient care," said Philip Cotter, Ph.D., Biocept's vice president and director of clinical laboratories. "It provides peace of mind to all Rh(D) negative patients early in pregnancy, and enables appropriate treatment of only those patients who require it."
"The test is the first of several noninvasive prenatal diagnostics developed by Biocept," Cotter said. "It is based on the I.D. (Isolating Fetal DNA) platform technology, a novel and proprietary approach to diagnostics developed in our laboratories."
Biocept, an emerging biotechnology leader, engineers novel solutions that provide the foundation for a new class of diagnostic assays. Biocept is based in San Diego, California, a major center for academic and industrial life sciences research. Founded in 1997, the company is privately held and draws on a scientific team rich in experience in life science. Its CLIA-accredited clinical laboratory is accredited by the College of American Pathologists and holds licenses in California and other states as required.