Blood test for Down syndrome Selection of humans?

08/07/2012

Specialized gynecologists will use a so-called prenatal test to determine whether the fetus of a pregnant woman suffers from Down's syndrome. The test is carried out by means of a blood sample. While the medical profession regards the new test as an achievement, the Disability Commissioner of the Federal Government calls for a ban on the planned check-up. This represents a human „Selection of unborn babies with Down syndrome“. For parents see themselves after a supposed positive result of the question of whether the child should continue to be discharged. In most cases, a termination of pregnancy provoked, so the fear of the critics.

The pharmaceutical company „LifeCodexx“ from Konstanz has a new blood test with the market name „Praena test“ developed. With the help of the blood test, the Down syndrome in embryos can be diagnosed in the mother's stomach. But the test procedure is highly controversial, since this one „Selection of humans“ represent and thus „violate human dignity“. Opponents now see themselves confirmed by a legal opinion on behalf of the Federal Government. The Federal Government's Disability Commissioner Hubert Hüppe said on Thursday in Berlin that the blood test violated the Genetic Diagnosis Act, according to the report. Hübbe spoke of one in this context „human selection“. This position is also joined by leading circles from CDU and CSU.

Legal opinion sees no medical benefit
The legal opinion was drawn up by the lawyer Klaus Ferdinand Gärditz from Bonn. With the „PraenaTest“ only the diagnosis Down Syndrome in an unborn child can be determined. Because the syndrome „neither curable nor treatable according to current knowledge“, could be certified in the process no medical benefit. However, according to the Genetic Diagnosis Act, prenatal examinations by a gynecologist must serve those needs. Also, the drug is according to the report „not marketable“, because the child's health in the womb through the medical device „specifically endangered“ become, so the lawyer.

Disability Commissioner called Test as „illegal“
Hüppe spoke vehemently against an approval of the test. The blood test was according to his words „illegal“. Almost exclusively it goes „to the selection of people with Down syndrome.“ Case numbers show that around 90 percent of parents in Germany decide against giving birth to their child when conventional Down syndrome has been identified. So it is to be feared that by the Praena test a „Rasterfahndung after people with a Down syndrome is reinforced“, as Hüppe criticized when presenting the legal opinion. The Disability Commissioner called on the competent health authorities of the Länder to oppose market approval and to refuse admission.

Sharp criticism from the side of politics
Hüppe received support from the deputy group leaders of the Union, Ingrid Fischbach and Johannes Singhammer. Both politicians turned against a license and criticized the product in an unusually sharp form. Any application of the product should not be approved as the test procedure „not on medical measures, but on a termination of pregnancy.“ On „Sorting out life“ offend her view „Blatant against human dignity“.

Blood test is expected to hit the market in July
Meanwhile, the company Lifecodexx defends its intention to market. The plan is to bring the Praenatest to the German medical market by July of this year at the latest. With the help of a simple blood test, the Down syndrome (Trisomy 21) can already be detected in a blood sample of pregnant women. Thus, dangerous amniotic fluid examinations could be avoided in many cases. In the blood portions of genetic information of the embryos would be located, which show laboratory technical evidence for specific chromosome changes. If there is a Down syndrome, then the chromosome 21 is not two but three times available, as a company spokesman explained ... The test procedure for trisomy 21 is also according to the company „risk-free and reliable“. Furthermore, the test is intended for women who are at risk for chromosome changes in the embryo. The test can take patients from 12 weeks of pregnancy to complete. For this, according to the Genetic Diagnosis Act, women must first seek the advice of a legally authorized and specialized doctor.

Medical Association defends the blood test
The pharmaceutical company received support from the medical profession. The chairman of the German Medical Association, Dr. med. Frank Ulrich Montgomery, that the German company has decided for prenatal diagnostics. „The wheel can not be turned back“, so the medical chamber chief. It was better „to use this blood test as a risky amniotic fluid examination“.

Test is not taken over by the health insurance companies
Already in July, the test will be offered in about 20 outpatient medical practices and centers for prenatal diagnostics in Germany. Since there is no medical benefit in the true sense, the test is not included in the catalog of benefits of the statutory health insurance. Women who decide to undergo such an examination must pay for the diagnostic procedure as a so-called additional benefit. A reimbursement of costs by the funds is not planned in the future. According to the company Lifecodexx the Praenatest should cost around 1200 euros. (Sb)

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Picture: Rainer Sturm