SAN DIEGO, June 3 /PRNewswire/ -- A presentation at the 14th International Conference on Prenatal Diagnosis and Therapy (ISPD) in Vancouver, BC, will highlight Biocept's I.D.Rh(D) Prenatal Diagnostic. I.D.Rh(D) is the first in a series of noninvasive prenatal diagnostic tests that can be performed with a simple maternal blood sample.
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.(TM) (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.
The presentation, to be given by Andrew Brooks, Ph.D., University of Medicine and Dentistry of New Jersey, concludes that isolation of fetal DNA from maternal whole blood for quantitative real-time PCR and Rh(D) genotyping is suitable for routine testing. Testing of multiple markers and controls, which I.D.Rh(D) offers, allows for a high degree of accuracy.
"We are very pleased to see our excellent clinical results validated in an independently reviewed scientific forum such as ISPD," said Gordon F. Janko, president and CEO of Biocept. "The I.D.Rh(D) test, which is now being used commercially, is an important step forward in noninvasive prenatal testing, and provides a higher level of personalized medicine for patients. It is the first of several noninvasive prenatal diagnostics developed in Biocept's laboratories, based on our novel and proprietary technology."
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.
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.
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.