2013 April-June; 7(2): 19–20. ISSN: 1971-3282 ISSN: 1971-3290

Regarding the legal and financial aspects connected to the use of these new screening tests, some people have criticized the high costs and excessive cost/benefit ratio, commercial interests and, finally, the legal complications that have already arisen from the introduction in the commerce of these techniques.

These aspects represent further elements to be taken into consideration so they can be better developed and possibly lead to future clinical use (1315).

  • - Screening for Down’s syndrome through the search for fetal DNA in maternal blood must not be encouraged as a first choice, given there are many combined screening tests that have been widely experimented and which, today, can be considered to be more reliable;
  • - Pregnant women that opt for the prenatal screening of aneuploidy through the analysis of foetal DNA in maternal blood must be informed that such testing does not provide clinically validated results;
  • - The recent widespread use of such testing in clinical practice has not been supported by the International scientific community and their commercial sale by promoting companies and laboratories creates risks for those who use them for diagnostic purposes from a legal point of view. Therefore, the clinic, in order to operate correctly, and to be sufficiently safeguarded against disputes regarding professional.
    Responsibility, must state that:
    • The clinical use of such screening is not valid and cannot yet substitute combined tests;
    • There is a huge difference between a screening test and a diagnostic test. If a pregnant woman is looking for certainty in testing his own baby, they must be informed that the only diagnostic tests available are those carried out on foetal material extracted by CVS or amniocentesis.