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April 25, 2022updated 29 Apr 2022 3:23pm

FDA warns of false results in genetic non-invasive prenatal testing

Neither the accuracy nor the efficacy of non-invasive prenatal testing (NIPT) has been authorised, cleared or approved by the FDA.

By GlobalData Healthcare

Congenital abnormalities are the leading cause of infant mortality worldwide; therefore, the use of prenatal screening in developed countries is common to detect chromosomal abnormalities and neural tube defects. The US Food and Drug Administration (FDA) recently issued a safety communications article informing healthcare professionals and patients of the dangers associated with genetic non-invasive prenatal testing (NIPT) or screening (NIPS) tests.

NIPTs highlight the possible risk of a foetus having certain genetic abnormalities by analysing small fragments of fetal DNA found in blood drawn from a pregnant person. While NIPTs are often used by healthcare professionals, neither their accuracy nor their efficacy has been authorised, cleared or approved by the FDA. Importantly, there have been reports where pregnancies have been terminated due to false results indicating genetic abnormalities based on the results of NIPTs alone. Since NIPS are not definitive in nature, as they only tell the potential risk of the foetus having a genetic disorder, it is important to pair their test results with a diagnostic test.

The prenatal screening market is estimated to reach $278.1m by 2030 at a negative compound annual growth rate (CAGR) of 2.3%. Since the FDA is encouraging increased vigilance in using NIPTs, GlobalData predicts a greater decrease in the NIPT market, as healthcare professionals and patients practice caution, and an increase in market share by other competing laboratory-based tests. There may, potentially, be an increase in prenatal diagnostic testing such as foetal echocardiograms and foetal blood sampling, as healthcare professionals pair these with NIPTs. Although these false negatives have been addressed only by the FDA, the US is the largest consumer of NIPTs and will thus reflect an overall decline in the NIPT market.

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