Non-Invasive Prenatal Screening and FDA concerns

The FDA is concerned about the patients who are taking non-invasive prenatal paternity testing. as there are some false results associated with NIPP testing. This specific  method provides you with information related to abnormalities that might be genetically linked with the fetus and help you prepare for a better future.

The health care providers might be using some prenatal paternity testing methods that have not been authorized by the FDA. Additionally, the performance and reliability of many non-invasive prenatal paternity testing methods are not approved by the FDA; thus, there is a probability of developing false results. as a result, the testing result can show that the fetus might develop a genetic condition, but in reality, the unborn baby might be in perfect health. Similarly, this genetic testing method is a screening process, so they can only identify certain types of conditions that might be associated with the fetus. In addition, these methods are not evaluation procedures that are mostly used for confirming or ruling out specific genetic abnormalities.

Moreover, FDA is also aware of the cases where healthcare providers have made some important decisions based upon these screening results without any extra confirmation evaluation. Additionally, many pregnant women have ended their pregnancies due to these NIPP testing results. Without the use of the diagnostic test, it is very difficult to say that the fetus may develop an abnormality based on the screening test only. There have been many cases where prenatal paternity testing shows that the fetus might develop an abnormality but when the birth happened baby was in perfect health.

As these cases have increased, the media has stated that there have been some concerns raised among the people. FDA is facilitating all the information that is necessary to educate the population so that the inappropriate use of NIPPs tests can be avoided. According to FDA, a person should talk to a genetic counselor or any other healthcare provider before getting prenatal paternity testing. Similarly, the patient should also discuss the results of non-invasive prenatal paternity testing with their genetic counselor before making any kind of crucial decision regarding their pregnancy. Furthermore, the healthcare provider should also know the risks and limitations of utilizing these screening methods, and they should not use these screening tests alone to confirm whether there is a genetic abnormality or not.

Recommendation of NIPP testing:

You should always talk to a genetic counselor or a health care provider before taking prenatal paternity testing as he or she will discuss what kind of testing methods would be beneficiary for you, like genetic evaluation tests like NIPS tests.

Afterward, you should not use screening tests as the sole evidence for your pregnancy-related decisions, as this test may not be totally accurate when it comes to identifying the genetic abnormalities of the fetus. In order to be sure, there are some invasive methods that can help you get some samples, like CVS or amniocentesis. However, these processes have some risk of miscarriage. Additionally, the confirmatory tests performed on these samples might not have been reviewed by FDA.

Moreover, you should discuss the results of NIPP testing with your healthcare provider so that it can be decided whether you need additional testing to confirm the results of a screening test.

If the screening has a positive test result, that means there would be a high probability of the fetus developing a genetic disorder. However, this does not mean that fetus is definitely going to develop a genetic abnormality.

Similarly, if the screening test has a negative result, this means that the fetus has a very low risk of developing a genetic issue. However, this also does not mean that child may not be carrying any genetic abnormality.

In order to be sure whether the fetus has the risk of developing a condition depends on many factors like how common or rare is the genetic abnormality and what are the different risk factors. For instance, the condition that happens due to microdeletion is missing small pieces of chromosomes, and this condition is very rare.

Moreover, if you want authentic prenatal paternity testing services, you can always come to Choice DNA; we have some of the most advanced technology to perform non-invasive prenatal paternity testing.