Nobody has approved the pregnancy and newborn tests in this stage
The FDA says so in its own words. And the biggest advertised accuracy figure is true of some women and untrue of most.
Most people assume that a test ordered by a clinic and run by a laboratory has been reviewed by somebody. For the pregnancy and newborn tests in this stage, it has not.
The FDA's own page on laboratory developed tests, current as of 19 September 2025, records three steps: On May 6, 2024, the FDA issued a final rule amending the definition of 'in vitro diagnostic products' in 21 CFR 809.3(a) to add the words 'including when the manufacturer of these products is a laboratory.' On March 31, 2025, a federal district court vacated that final rule. On September 19, 2025, the FDA issued a final rule reverting to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.
The FDA tried to bring these tests under its review. A court struck that down. The FDA then restored the old rule. That is all this guide states, because that is all the FDA's own page states.
Nearly every pregnancy and newborn test in this stage is a laboratory developed test: expanded and genome-wide cfDNA, single-gene cfDNA panels, prenatal exome and genome sequencing, and commercial newborn genomic screening. None of them requires FDA review before it is sold. This guide makes no claim either way about how embryo scoring is regulated in the United States, because no current source on that was verified for it.
For the blood tests used in pregnancy the FDA has said so directly, in a safety communication issued on 19 April 2022: While health care providers widely use NIPS tests, none have yet been authorized, cleared, or approved by the FDA.
That sentence is about non-invasive prenatal screening, and it is quoted here for those tests only.
The accuracy and performance of NIPS tests have not been evaluated by the FDA.
And on the microdeletion panels: However, reliability of positive screening results was far lower for microdeletions, with the positive predictive value ranging from about 2% to 30%, depending on the condition.
That range arrives with no population and no prevalence attached, and the FDA supplies neither. So set it beside the one figure that does have both. In the largest prospective cohort with genetic confirmation, the positive predictive value for the 22q11.2 deletion was 23.7% (95% confidence interval 11.44 to 40.24), at a prevalence of 1 in 1,524 in that cohort, among 18,289 pregnancies with a genetic outcome, 98.3% of whom had screened low risk. A predictive value without a population behind it is not yet a number you can use.
The FDA's three pieces of advice to patients, in the FDA's words: Talk with a genetic counselor or other health care provider before deciding to have prenatal testing and to discuss which tests to use, including genetic screening tests such as NIPS tests.
Do not use the results of screening tests such as NIPS tests alone to make decisions about your pregnancy because the results of these tests may not accurately reflect whether your fetus has a genetic abnormality.
Discuss the results of genetic prenatal screening tests and what the results may mean with a genetic counselor or other health care provider.
That advice exists because people do exactly that. In a US series of 114 women with a positive cfDNA result, at two academic centres where 95% received counselling from a certified genetic counsellor, 11 of 56 terminations for a suspected trisomy went ahead without a confirmatory chromosome test. In the same cohort, a positive result with a normal ultrasound was correct 58.6% of the time.
How a true number can still mislead. One company's live page, read on 27 August 2026, advertises: >95% positive predictive value (PPV) for trisomy 21.
No population is stated. No prevalence is stated.
Here is the profession's own current table for the same condition, by maternal age. These are modelled values, published by SMFM.
| Age | Modelled positive predictive value for trisomy 21 |
|---|---|
| 20 | 48% |
| 25 | 51% |
| 35 | 79% |
| 40 | 93% |
A single figure above 95% is true of some women and untrue of most. The same predictive value cannot apply at 20 and at 40, because it depends on how common the condition is in the group being tested. That is not a technicality. It is the mechanism by which this whole field misleads.
To its credit, that same page also states plainly: Panorama is a screening test, which means that this test does not make a final diagnosis. High risk test results need diagnostic confirmation by alternative testing methods.
And SMFM tells clinicians something remarkable about the laboratories it works with every day: As some laboratories use their own internal data or proprietary metrics in these calculations, clinicians may consider using independent PPV resources to verify the laboratory report.
"Has this test been reviewed or approved by the FDA?"
"Nothing gets decided on this result until a diagnostic test confirms it. Can we book that first?"