FDA WARNING to patients and healthcare providers published yesterday!
Non-invasive prenatal screening (NIPS, also referred to as NIPT) is widely used but “none have yet been authorized, cleared, or approved by the FDA. The accuracy and performance of NIPS tests have not been evaluated by the FDA and these tests can give false results, such as reporting a genetic abnormality when the fetus does not actually have one.”
These tests are ‘screening’ tests, NOT ‘diagnostic’ tests. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy”.
Recommendations for patients, as well as healthcare providers are outlined in this safety publication.
“The NIPS tests currently being offered are marketed as laboratory developed tests (LDTs). Most LDTs, including NIPS tests, are offered without FDA review. While LDTs are medical devices under the Federal Food, Drug, and Cosmetic Act, the FDA has had a general policy of enforcement discretion for most LDTs since the Medical Device Amendments were enacted in 1976. That means that FDA does not generally enforce applicable regulatory requirements for most LDTs. The FDA is continuing to work with Congress on legislation to establish a modern regulatory framework for all tests, including LDTs.”
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The Center for Genomic Interpretation (CGI) is an independent 501(c)(3) nonprofit organization with the mission to save and improve lives through encouraging careful stewardship of clinical genetics, genomics and precision medicine. Too frequently the precision medicine goals of patients and their providers are unknowingly thwarted by inaccurate or ineffective genetic or genomic testing. We facilitate the realization of value from among the confusing scramble of the new precision medicine era. The CGI team consists of clinical genetics and genomics scientific leaders, healthcare policy veterans, experienced business professionals, and others dedicated to helping stakeholders achieve the vision and promise of precision medicine. CGI offers a range of programs and services targeted to all stakeholders including patients, providers, payers, pharmaceutical developers, policy makers and laboratories.