Case type IVF & Fertility Treatment Injuries

Polygenic Embryo Screening (PGT-P)

You paid for embryo risk scores and now question what you were told they could do. Tell us your story.

CBW Law reviews concerns from people who used polygenic embryo screening, often called PGT-P, and believe its benefits or limits were described inaccurately. We look at what you were told, what you signed and what happened next. Tell Us Your Story. Contacting us does not create an attorney-client relationship.

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Polygenic embryo screening gives each IVF embryo a score meant to estimate its genetic odds of developing common conditions, such as diabetes or heart disease, later in life. The scores are probabilities, not diagnoses, and the major U.S. and European medical genetics and fertility societies say the method is not ready for clinical use. The companies that sell it disagree and say their scores are well validated. Using or offering PGT-P is not, by itself, wrongdoing. A legal question usually comes from how the test was described and whether its limits were disclosed.

What polygenic embryo screening does

PGT-P combines two technologies: IVF with embryo biopsy, and a polygenic risk score built from studies of adults1. A polygenic risk score adds up the small effects of many common genetic differences into a single number. A higher score predicts a higher chance of a condition than a lower score, but it cannot say whether a person will or will not be diagnosed1. In practice, the process usually looks like this:

Embryos are created through IVF and a few cells are removed from each one.
The lab genotypes the cells, often using the parents’ DNA to help fill in the embryo’s genome1.
Each embryo is scored for conditions such as diabetes, heart disease or certain cancers1.
The embryos are ranked, and the parents use the ranking to help choose which embryo to transfer10 11.

Some companies also offer scores for traits that are not diseases. NPR reported in May 2026 that one company predicts height, BMI, longevity and IQ, and another lets parents look at traits such as eye and hair color10. ASRM has said PGT-P should not be used for nonmedical trait selection2.

How PGT-P differs from PGT-A, PGT-M and PGT-SR

PGT-P is often sold alongside the more established types of preimplantation genetic testing, but it answers a different kind of question:

*PGT-A* looks for missing or extra chromosomes. See our page on PGT-A testing errors.
*PGT-M* looks for a specific single-gene condition known to run in a family. See PGT-M testing errors.
*PGT-SR* looks for unbalanced chromosome pieces when a parent carries a rearrangement. See PGT-SR testing errors.
*PGT-P* estimates relative risk for common conditions shaped by many genes and by environment, and ranks embryos against each other11.

The first three look for a specific finding. PGT-P does not. Sigal Klipstein, MD, chair of ASRM’s Ethics Committee, explained in a January 2026 interview with Healio that PGT-P is not designed to tell whether a child will develop a disease. It only predicts whether a child from one embryo may be at higher risk than a child from a sibling embryo11. The known limits of PGT-A, PGT-M and PGT-SR, such as mosaicism and sampling error, are explained on our PGT results and testing limitations page.

A risk estimate, not a diagnosis

Most of the scientific debate is about how much these scores can tell a family. Several limits come up again and again in the research and in professional statements.

Relative risk vs. absolute risk

A relative risk reduction can sound large when the actual change in risk is small, especially for rare conditions6. A 2021 analysis in the New England Journal of Medicine estimated that choosing among embryos by score could cut the relative risk of type 1 diabetes by about 35% for parents of European ancestry. Because lifetime risk in the U.S. is only about 0.34%, that is a drop of about 0.12 percentage points6. The authors recommended that absolute risk be the main figure shown and that relative risk never be presented alone6. ACMG gives a similar example: a person can be in a very high-risk percentile (the 85th) and still have a low absolute risk (15%)1.

Ancestry

Most scores were built from data on people of European ancestry, and they predict less well for others1 6. In the 2021 simulations, the estimated drop in type 2 diabetes risk was 5.5 percentage points for European ancestry but 2.6 for African ancestry6. ASRM cited a lack of diverse genomic data as one reason the scores may not give meaningful guidance3.

Environment and the future

Diet, lifestyle and future medical treatment can strongly affect whether someone develops these conditions, and ASRM says polygenic scores account for only a small share of clinical variation3. ACMG notes that the scores come from adults who grew up in past decades, and that unknowable changes in the environment may weaken their predictive power for a child born today1. ESHRE says the scores cannot include environmental information5.

Comparing sibling embryos

Embryos from the same two parents are more alike than strangers, so their scores vary less, and part of a score’s power in adult studies comes from family environment, which siblings share6. ESHRE adds that a family usually has few embryos to choose from, that sibling embryos show great overlap in small risk factors, and that selecting against one disease may raise the risk of another5. A 2026 study of 310 PGT-M cycles found that score differences between embryos depended on how many embryos were available and on the parents’ own scores, and the authors stressed that this does not demonstrate any reduction in lifetime disease9. An earlier modeling study found that excluding only the highest-scoring embryos gives minimal risk reduction8.

What medical societies say about PGT-P

Professional groups in the U.S. and Europe have been consistent, though the companies offering PGT-P dispute their view.

Professional statements, by date

ESHG, December 2021: The European Society of Human Genetics called PGT-P an unproven, unethical practice and said no clinical research had assessed its diagnostic effectiveness in embryos4.
ESHRE, February 2022: The European Society of Human Reproduction and Embryology backed ESHG and said the clinical utility of embryo polygenic scores is low to non-existent at present5.
ACMG, 2024: The American College of Medical Genetics and Genomics concluded that PGT-P’s clinical utility is unproven and that it should not currently be offered as a clinical service1.
ASRM, Nov.–Dec. 2025: The American Society for Reproductive Medicine’s Ethics and Practice Committees said PGT-P is not ready for clinical use and should be used only in research under IRB oversight2 3.

The disagreement is real. A 2024 review supported by ESHRE found that, under best-case assumptions, models predict large relative risk reductions for some diseases, but that real-world gains may be smaller because of limited embryo numbers and uncertain future accuracy7. Scientists tied to one PGT-P company published a rebuttal to the ESHG statement15, and the companies dismissed the criticism, telling NPR in 2026 that their estimates are state of the art and carefully validated10. Those claims are contested, not settled.

Availability and U.S. rules as of October 2026

PGT-P is commercially available in the United States. NPR reported in May 2026 that a handful of companies offer it, that the cost can reach $50,000 plus IVF, and that the companies say they have scored thousands of embryos for hundreds of parents10. Some patients add it to IVF they already need; others do IVF only to screen embryos10.

Federal oversight is limited. FDA issued a rule in May 2024 to treat lab-developed tests as medical devices, a federal court vacated it on March 31, 2025, and FDA formally removed it on September 19, 202512. CMS oversees lab quality through CLIA, but in a joint January 2024 statement with FDA, issued while FDA was pursuing its rule, CMS said it “does not have the expertise to assure that tests work”13. ACMG has warned that U.S. labs can market reproductive tests the broader medical community considers unvalidated1.

Advertising is a separate question. FTC staff guidance from December 2022 says advertising must be truthful and not misleading, that health claims generally need support from competent and reliable scientific evidence, and that these principles apply to any health-related product14. The guidance explains the law but does not itself have the force of law14. Researchers writing in 2021 urged the FTC to oversee how embryo polygenic scores are described to patients6.

Key dates

December 2021

ESHG calls PGT-P unproven and unethical4.
February 2022

ESHRE supports the ESHG position5.
2024

ACMG says PGT-P should not currently be offered clinically1.
March 31, 2025

Federal court vacates FDA’s rule on lab-developed tests12.
September 19, 2025

FDA removes the vacated rule text from its regulations12.
December 8, 2025

ASRM releases its report finding PGT-P not ready for clinical use3.
May 2026

NPR reports several companies selling embryo scores for disease and traits10.

Because PGT-P is offered while its value is disputed, what patients are told matters a great deal. ACMG says informed consent for an unproven test is problematic at best, that the speculative nature of the testing must be made clear, and that reports should show absolute risk, explain that the result is a risk estimate rather than a diagnosis, and state that a low score does not rule out disease1. ACMG also flags a possible conflict of interest when counseling comes from the lab selling the test1. The NEJM authors added that companies must be careful about claims in blogs, websites, ads and media statements, not just in consent forms6.

Disclosure that may be relevant in a review includes whether you were told:

That the scores are probabilities and cannot diagnose or prevent a disease
The absolute risk change, not only a relative or percentile figure
How well the scores work for your ancestry
That a few embryos may give little real choice, and scores may barely differ
That lowering one risk may raise another
That major medical societies do not support routine clinical use
Who provided counseling, and whether they worked for the lab

CBW Law does not treat PGT-P itself as wrongdoing; we look at whether people were told the truth about it.

Possible harms tied to PGT-P

The 2024 ESHRE-supported review lists several possible harms7. Not every family will face them, and none proves a claim on its own:

IVF that was not medically needed, with its own risks and cost
A possible reduction in IVF success rates
Embryos set aside or discarded because of their ranking
Confusion, incomplete counseling and too many choices
False reassurance if a lower-risk child later develops the condition, a concern ACMG also raises1

When a PGT-P concern may call for a lawyer

A PGT-P lawsuit is not about a test failing to prevent a disease it was never able to prevent. A lawyer may want to look more closely when:

Ads, a website or a salesperson presented the scores as a way to prevent disease
You were shown relative risk or percentiles but never absolute risk
Limits for your ancestry were not disclosed or were buried in fine print
You started IVF only for screening without a clear talk about IVF’s risks
A lab error affected which embryo was ranked or transferred
Embryos were discarded based on scores you did not understand

Who may be responsible

Responsibility depends on the facts and is never assumed. A review may consider:

*The testing company*, for its claims, reports and lab work
*The fertility clinic*, for biopsy, sample handling and what it told you
*A physician or genetic counselor*, for counseling and consent
*Marketing partners*, for ads or endorsements that made specific claims

Filing deadlines for PGT-P claims

Deadlines depend on the state and the kind of claim. In California, for example, a negligence claim against a licensed health care provider generally must be filed within three years of the injury or one year after it was or should have been discovered, whichever comes first, with limited exceptions such as fraud or intentional concealment16. Claims under California’s unfair competition law, which covers misleading advertising, have a four-year limit17. Other states set different periods and steps, so it is worth asking an attorney early.

Tell Us Your Story →

Records that help a PGT-P claim review

Records worth gathering

What you were told

Screenshots or copies of ads and web pages
Emails, chats and sales materials
Consent forms and order forms
Counseling notes or call summaries

What the lab reported

Embryo score reports and rankings
Any absolute-risk or ancestry notes
Parent genotyping results
Any corrected or reissued reports

Treatment and cost

IVF cycle and transfer records
Embryo disposition forms
Invoices, receipts and payment plans
Explanation of benefits forms

What happens after you contact CBW Law

How a review works

You tell us what happened

Tell us which company and clinic were involved, what you were told and what happened. A rough timeline is enough.
We gather the paper trail

With your permission, we collect the marketing, consent, lab and clinic records.
We compare claims with evidence

We look at what was said about the scores against what the published evidence and professional guidance said at the time.
We explain your options

We tell you what we found, whether we see a basis for a claim, and how deadlines may apply.

Plain English

Medical, Health & Insurance

Embryo score reports mix genetics, statistics and billing terms. These short definitions may help.

Genetics

Polygenic risk score (PRS): A single number that adds up the small effects of many genetic differences to estimate risk for a condition1.
Complex (multifactorial) condition: A condition shaped by many genes plus lifestyle and environment, such as heart disease, high blood pressure or diabetes3.
Monogenic condition: A condition caused mainly by a change in one gene.
Pleiotropy: When the same genetic differences affect more than one trait or disease, so selecting for one can change another6.

Statistics

Absolute risk: The actual chance that something will happen, such as 1 in 100.
Relative risk: How one chance compares with another, such as “30% lower,” which can describe a very small real change.
Percentile: Where a score falls compared with a reference group. A high percentile can still mean a low absolute risk1.
Clinical utility: Whether using a test actually improves health outcomes1.

IVF and testing

Embryo biopsy: Removing a few cells from an embryo so they can be tested.
Genotyping: Reading a person’s or an embryo’s DNA at many known positions.
Laboratory-developed test (LDT): A test designed and run within a single laboratory13.

Insurance & billing

Elective add-on: An optional service sold with IVF that a health plan may not cover.
Out-of-pocket cost: What you pay yourself after any insurance payment.
Explanation of benefits (EOB): An insurer statement showing what was billed, paid and owed.
Payment plan or financing: An agreement to pay for treatment or testing over time, often with its own terms and fees.

Questions

Frequently asked PGT-P questions

Short answers to common questions about polygenic embryo screening.

Can PGT-P tell me whether my child will get a disease?

No. PGT-P gives risk estimates, not diagnoses. ACMG says a low score does not rule out the disease and only reflects a ranking of lifetime risk1. Environment, lifestyle, future treatments and genetic changes the score does not capture all play a part1 3.

Is PGT-P the same as PGT-A or PGT-M?

No. PGT-A looks for chromosome problems and PGT-M looks for one known gene condition. PGT-P compares embryos’ estimated risk for common conditions influenced by many genes11. They are often ordered together, but they answer different questions.

Is PGT-P available in the United States?

Yes. NPR reported in 2026 that several U.S. companies offer it10. Being available does not mean professional groups endorse it. ACMG and ASRM have said it should not currently be offered as a clinical service1 3.

Does FDA review PGT-P before it is sold?

FDA’s 2024 rule that would have treated lab-developed tests as medical devices was vacated by a federal court in March 2025, and FDA removed it in September 202512. Labs are subject to CLIA quality rules, but CMS has said it does not have the expertise to assure that tests work13.

Why do scores work less well for some families?

Most scores were built from data on people of European ancestry, and they predict less well for people of other ancestries1 6. Embryos from the same parents also tend to have similar scores, which limits how much ranking them can change real risk5 6.

My lower-risk child developed the condition. Do I have a lawsuit?

Not because of that alone. PGT-P cannot ensure a child avoids a disease, and a lower score never ruled the condition out1 11. A claim, if any, would more likely turn on how the test was marketed or explained, or on a lab error. An attorney can review what you were told and what the records show.

What should a company have told me before testing?

Professional guidance says patients should understand that PGT-P is a risk estimate, not a diagnosis, that it has not been shown to improve outcomes, and what the absolute risk change is1 6. Whether a specific omission matters legally depends on the facts and the state.

Can I bring a claim if I was misled about PGT-P?

Possibly. Laws against deceptive advertising apply to health-related products, and FTC guidance says health claims generally need support from competent and reliable scientific evidence14. Whether you have a claim depends on what was said, what you relied on and what harm followed. A lawyer can explain the options in your state.

Is selecting embryos for traits like height or IQ part of PGT-P?

Some companies offer trait predictions, NPR reported in 202610. ASRM has said PGT-P should not be used for nonmedical trait selection2. Trait prediction raises the same accuracy questions, and many critics see added ethical problems.

How long do I have to act?

It depends on your state and the type of claim. In California, for example, professional negligence claims against health care providers generally must be filed within three years of the injury or one year after discovery, whichever comes first, while unfair competition claims have four years16 17. Asking early protects your options. You can also read more on our IVF and fertility treatment injuries page.

Tell Us Your Story

Polygenic embryo screening ranks embryos by estimated risk. Major medical societies say its benefits are unproven, and the scores cannot diagnose or prevent disease. A legal question usually depends on how the test was sold and explained, not on the outcome alone.

If you believe you were given misleading information about PGT-P, or an error affected your embryos, CBW Law can review what happened and tell you what we find. Tell us your story when you are ready.