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Now you can offer a highly-specific direct detection test for fetal RHD status to your patients safely and comfortably from a simple blood sample. The SensiGene™ Fetal RHD Genotyping test is powered by proprietary SEQureDx™ technology, which is based on the pioneering work of Professor Dennis Lo1. Through SEQureDx technology, DNA material is extracted from the blood of the mother, enabling direct genetic testing to assess fetal status in the first trimester.

Some Clinical Applications

• Clarify fetal RHD status without testing the father
   > Avoids the costs of paternity testing
   > Avoids paternal genotyping
• Clarify fetal RHD status when maternal anti-D titers are unclear
• Identify the RHD (-) fetus in mothers who are opposed to immunization(s) and vaccines
• RhD (-) sensitized patients
  > Avoid invasive testing by CVS or genetic amniocentesis
     (decreases risk of alloimmunization)

Targeting Multiple Regions of the Gene

This novel test method is designed to detect circulating cell-free fetal (ccff) DNA from maternal blood and examine multiple regions of the gene that is known to be the most common genetic basis of RhD negative phenotypes. The test interrogates targets within 3 exons located on the RHD gene in chromosome one. The test also incorporates male-specific targets on the Y chromosome because it has been demonstrated that Rh alloimmunization occurs more frequently in male fetuses.2 There are quality control metrics added to the reaction to ensure accuracy and a quality control test is used to facilitate the distinction between maternal and female fetal DNA .

Sequenom CMM’s Commitment

This test was developed under strict quality standards and validated at Sequenom Center for Molecular Medicine, a CAP accredited and CLIA-certified laboratory.

References

1. Lo, Y.M.D., Corbetta, N., Chamberlain, P.F., Rai, V., Sargent, I.L., Redman, C.W. (1997) “Presence of fetal DNA in maternal plasma and serum.” Lancet 350:485-7.
2. Ulm, B., Svolba, G., Ulm, M.R., Bernaschek, G., and Panzer, S. (1999) “Male fetuses are particularly affected by maternal alloimmunization to D antigen.” Transfusion 39:169-173