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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, usingBiocept's proprietary I.D.(TM) (Isolating Fetal DNA) platform technology (U.S.patents pending). The fetal DNA is analyzed in Biocept's CLIA-accreditedclinical laboratory to determine Rh(D) genotype. Similar noninvasive testshave been available routinely in some countries outside the US.
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The presentation, to be given by Andrew Brooks, Ph.D., University ofMedicine and Dentistry of New Jersey, concludes that isolation of fetal DNAfrom maternal whole blood for quantitative real-time PCR and Rh(D) genotypingis 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 anindependently 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 usedcommercially, is an important step forward in noninvasive prenatal testing,and provides a higher level of personalized medicine for patients. It is thefirst of several noninvasive prenatal diagnostics developed in Biocept'slaboratories, based on our novel and proprietary technology."
I.D.Rh(D) is the only fetal Rh(D) diagnostic that identifies fetal DNA inmaternal blood in all cases in which a diagnosis can be delivered-whether thefetus 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 chorionicvillus sampling (CVS), which carry their own risks to the fetus. For thisreason, physicians have routinely administered anti-D immune globulininjections, a human blood product, to all Rh(D) negative women at 28-29 weeksof gestation.
About Biocept
Biocept, an emerging biotechnology leader, engineers novel solutions thatprovide the foundation for a new class of diagnostic assays. Biocept is basedin San Diego, California, a major center for academic and industrial lifesciences research. Founded in 1997, the company is privately held and draws ona scientific team rich in experience in life science. Its CLIA-accreditedclinical laboratory is accredited by the College of American Pathologists andholds licenses in California and other states as required.
SOURCE Biocept
