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Risk-Free Non-Invasive Prenatal Paternity Test Announced

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easyDNA has announced the launch of its risk-free prenatal paternity test. This test is based on the analysis of cell-free fetal DNA in the maternal bloodstream using highly advanced SNP (single nucleotide polymorphism) microarray technology developed by Gene Security Network (GSN), a privately held genetics company. Apart from being extremely accurate, the prenatal test is also 100% risk-free for the unborn baby and the mother as it is carried out using standard blood samples from the mother and alleged father.

Expanding on the benefits of their prenatal paternity test, Sales and Marketing Director, Mr. Andrew Alexander commented, “Scientists have focused on finding a prenatal test that eliminates all risks associated with amniocentesis or chorionic villus which are known to carry certain risks including damage to the baby’s limbs and miscarriage. Fetal DNA analysis for this non-invasive test can be done by means of a simple blood draw from the expectant mother. It is 100% safe and can be collected by a doctor or nurse. In terms of the technology used, this test is truly groundbreaking and innovative."

The company also highlighted a number of other benefits of this test, most noticeably the fact that the test can be done as early as nine weeks of pregnancy, well within the first trimester. Validation studies conducted by the laboratory have shown no difficulty in obtaining the necessary fetal DNA from the blood sample to complete the test. easyDNA has also noted that being able to carry out the non-invasive test at nine weeks provides an added advantage over alternative prenatal testing methods which require samples to be taken at a later stage in the pregnancy.

The result of the test is greater than 99.9% accurate which is comparable to many standard paternity tests performed after birth. Data on pre-clinical validation of the test was recently presented at the 23rd International Symposium of Human Identification in Washington DC.As explained by Zachary Demko, PhD, Director of Research and Development at GSN, “Over 317,000 individual genetic markers known as SNPs (single nucleotide polymorphism) are analyzed using microarray technology. Since these markers vary from person to person, evaluation of such a large number of markers creates a specific genetic blueprint. Through advanced bioinformatics software we compare these blueprints to establish or rule out paternity.”

Asked to elaborate on the difference between standard DNA tests and the prenatal test offered, the Dr. Demko stated “this test differs from traditional STR (short tandem repeat) based tests which measure areas of the genome where the number of copies of the genetic code vary from person to person. When used on long strands of intact DNA, STR testing is very accurate. However, due to the highly fragmented state of cell-free fetal DNA found in the maternal blood – STR testing becomes ineffective when applied to prenatal paternity testing.”

easyDNA has launched the test in a number of countries and so far the response has been very positive. Commenting further Mr. Alexander stated, “People calling have been really receptive to this test; clearly, expectant mothers are well aware of the risks entailed in invasive prenatal testing methods such as amniocentesis and are relieved to learn about the option of a test that bypasses all these risks.”

The proprietary technology for genetic testing of tiny amounts of fetal DNA, as small as that from a single cell, is used at over one hundred in-vitro fertilization centers and hospitals around the world and has been published in the journal Human Reproduction. The technology has now been validated on cell free circulating DNA for paternity testing. That data has been submitted to AABB for certification and is also being prepared for submission to a peer reviewed journal.