Natera Sold Hope to Desperate IVF Patients. The Science Says It Didn’t Work.

A federal class action filed in the Northern District of California accuses diagnostics company Natera, Inc. of building a profitable product on a foundation that scientists have described as “a castle built on sand.” The product is PGT-A: a genetic test sold as an add-on to in vitro fertilization, marketed as a way to screen embryos and boost the odds of a healthy baby. According to the complaint, none of that holds up.

The Non-Financial Ledger

People pursuing IVF are not casual shoppers. They are enduring weeks of hormone injections, bruising, swelling, and procedures under general anesthesia, chasing what is often their only chance at a child. The complaint says Natera knew exactly who it was selling to and used that vulnerability against them.

The most permanent harm alleged is not financial. When PGT-A labels an embryo “aneuploid” or abnormal, that embryo is typically discarded or never transferred. But re-testing showed many of those embryos were actually normal. Some patients who transferred “abnormal” embryos anyway went on to deliver healthy newborns. The complaint alleges that inaccurate results caused viable embryos, described as “precious and irreplaceable,” to be thrown away, and in some cases cost patients with diminished ovarian reserve their only chance to have a baby.

Embryos are irreplaceable because eggs are. A woman is born with a finite supply that only shrinks with age. A false “abnormal” label is not a mistake that can be undone with a refund. It can be the end of a family that was never allowed to begin.

Legal Receipts

The following passages are drawn directly from the complaint and the source documents it cites. Each one is Natera’s own conduct or the scientific record turned against its marketing.

“Study Shows Natera’s Spectrum Preimplantation Genetic Testing for Aneuploidy Improves IVF Outcomes for All Women, Regardless of Maternal Age … Spectrum’s patented SNP-based technology with Parental Support provides a highly comprehensive 24-chromosome PGT-A with an accuracy greater than 99 percent per chromosome call.”

• This is Natera’s own August 2, 2018 press release, the basis for the “99% accurate” and “improves outcomes for all women” claims repeated to consumers.
• The complaint alleges this headline claim is contradicted by the company’s own underlying study.

“the data presented in this study are not sufficient to demonstrate the absolute impact of SNP-based PGT-A on IVF outcomes”

• This admission comes from Natera’s own 2018 study, the same research it used to build the marketing chart claiming higher pregnancy rates.
• Natera’s researchers also conceded the study “was not randomized,” a core weakness scientists say invalidates the marketing claims.
• In plain terms: the company’s own data did not prove what its advertising told customers it proved.

“the value of preimplantation genetic testing for aneuploidy (PGT-A) as a universal screening test for all patients undergoing in vitro fertilization (IVF) has not been established.”

• This is the American Society for Reproductive Medicine, the leading professional body in the field, stating in November 2023 that the test’s value is not established.
• The complaint alleges Natera omitted this material fact from the marketing materials that plaintiffs saw and relied on.

“amongst the youngest patients (age <35), not only does there appear to be no benefit to PGT-A, but there appears to be a considerable reduction in cumulative live birth rates per cycle start."

• This finding, from an analysis of 133,494 IVF cycles, directly contradicts Natera’s claim of improved pregnancy rates for “all ages.”
• It suggests the product may have actively lowered the odds of a baby for the youngest patients it was sold to.

Public Deception: What Buyers Were Told vs. What the Science Said

The complaint documents a direct gap between Natera’s marketing to patients and the body of published research the company was aware of.

• Natera claimed PGT-A is “greater than 99% accurate.” Reanalysis studies found concordance rates as low as 42.6% for mosaic results, and one study suggested a false positive rate near 55%.
• Natera claimed the test “improves IVF outcomes for all women, regardless of maternal age.” A New England Journal of Medicine randomized trial found conventional IVF was noninferior and produced a higher cumulative live-birth rate.
• Natera claimed the test decreases the chance of miscarriage. ASRM stated the value of PGT-A to lower miscarriage risk “is unclear.”
• Natera claimed the test reduces time to pregnancy. Published research found utilizing PGT-A does not decrease time to pregnancy.
• Natera’s consent form told patients the test had a “98 to 99% accuracy rate,” a figure the complaint says was never properly validated for Natera’s own assay.

How Long the Warnings Were Ignored

The complaint lays out a chronology in which the scientific case against PGT-A mounted for years while Natera kept selling. The gap between documented warnings and the company’s marketing is the core of the case.

The Anatomy of a “Result”: Testing the Wrong Cells

The complaint alleges the entire product rests on a biological assumption the science has undermined: that a few outer cells can speak for the whole embryo. They cannot.

• The biopsy is taken from the trophectoderm, the outer layer that becomes the placenta, not from the inner cell mass that becomes the fetus.
• Research cited in the complaint shows placentas are “inherently mosaic,” carrying chromosomal abnormalities even when the fetus is completely normal.
• Studies found embryos can self-correct after the blastocyst stage, meaning an early “abnormal” result may not reflect what the embryo actually becomes.
• The complaint alleges Natera told consumers where the biopsy came from but omitted that the inner cell mass self-corrects more effectively than the tested outer layer.

Profit-Maximization at All Costs

The complaint frames the marketing as a deliberate business strategy: keep selling an unvalidated test to a captive, emotional market because it was extraordinarily profitable.

• The average cost of PGT-A is approximately $5,000 per IVF cycle, almost always an out-of-pocket expense because insurers refuse to cover it.
• The PGT-A industry generates an estimated $300 million to $400 million per year.
• Marketing drove adoption from 13% of IVF cycles in 2014 to roughly 40% by 2021, even as live-birth rates among IVF patients declined.
• The global preimplantation genetic testing market was valued at $0.7 billion in 2023 and projected to reach $1.2 billion by 2028.
• The complaint alleges Natera never funded the randomized, non-commercial trials scientists repeatedly demanded, choosing continued sales over validation.

Legal Minimalism: The Letter but Not the Spirit

The complaint describes how the industry reframed the product to dodge scrutiny while changing nothing about the underlying science.

• In July 2016 the Preimplantation Genetic Diagnosis International Society published practice guidance that, per the complaint, “contained no references to valid scientific literature” and was never peer reviewed.
• At the same time, the industry group renamed the product from “screening” (PGS) to “testing” (PGT-A), swapping a word that implies uncertainty for one that implies certainty.
• The complaint alleges this industry body is “heavily influenced by and comprised of influential members of the genetic testing industry” and is headquartered inside a genetic testing laboratory.
• Natera’s consent form stated a “98 to 99% accuracy rate,” technically referencing “per chromosome call” language while, the complaint alleges, leaving patients to believe the whole result was that reliable.

Manufactured Consent

The complaint alleges Natera used a press release built on its own inconclusive study to shape public and clinician perception in its favor.

• Natera’s August 2, 2018 press release announced a study “demonstrating the value” of Spectrum and claimed it “Improves IVF Outcomes for All Women, Regardless of Maternal Age.”
• The complaint notes the study behind that headline was not randomized and, in the researchers’ own words, was “not sufficient to demonstrate the absolute impact” of the test.
• Natera marketed directly to individual consumers and separately to clinics and clinicians, using the same disputed claims to reach patients through their own doctors.
• Patient education materials, the complaint alleges, exceeded the CDC’s required fifth-grade reading level, making truthful comprehension harder for the people paying.

Societal Impact Mapping

The alleged harm extends beyond individual buyers into public health and economic inequality across the fertility system.

Public Health

• Viable embryos labeled “abnormal” were discarded or never transferred, with re-testing showing many were actually normal.
• The complaint alleges patients with diminished ovarian reserve lost their only chance at a child from a given IVF cycle due to inaccurate results.
• PGT-A can result in additional egg retrievals, subjecting patients to more hormone injections, sedation, and procedures with real physical risk.
• Widespread adoption occurred as IVF live-birth rates declined, raising the possibility the test worsened outcomes at population scale.

Economic Inequality

• At roughly $5,000 per cycle out of pocket, the test is a wealth filter layered on top of already expensive IVF that most states do not require insurers to cover.
• Insurers including United Healthcare and Aetna independently deemed PGT-A “unproven,” “experimental,” and “not medically necessary,” leaving the full cost on patients.
• Patient materials written above national literacy levels risk pushing the least-informed consumers toward the most expensive, least-supported add-on.

The “Cost of a Life” Metric

Who Pays? Following the Cost

The complaint documents a straight line from Natera’s revenue to the wallets of individual patients who had no realistic way to verify the claims.

• Because insurers refuse to cover PGT-A as “unproven,” the full cost shifted directly onto patients as an out-of-pocket add-on.
• Plaintiff Melissa Klein paid approximately $2,850 plus additional costs for testing she alleges she would not have bought if told the truth.
• Plaintiff Valerie Griffeth paid approximately $474 plus additional costs under the same alleged misrepresentations.
• Across an estimated 40% of U.S. IVF cycles at roughly $5,000 each, the aggregate cost absorbed by patients feeds an industry generating $300 to $400 million per year.

This Is the System Working as Intended

The complaint describes an enforcement vacuum: a test sold for over a decade with no FDA-style validation gate, no randomized trial requirement, and industry self-regulation that the cited literature calls insufficient.

• An article in Human Genomics cited by the complaint concluded that “industry self-regulation has shown to be insufficient” for PGT-A.
• The renaming from “screening” to “testing” by an industry-dominated body, per the complaint, changed the marketing language without any change in scientific support.
• Insurers, not regulators, were the ones documenting that PGT-A was “unproven” and “not medically necessary,” yet the product kept selling at scale.
• Natera discontinued Spectrum in December 2025 on its own terms, after roughly sixteen years of sales and only as litigation mounted, not through any regulatory ban documented in the source.

What a Legitimate Fix Looks Like

Editorial analysis. The core failure this case exposes is that a laboratory-developed genetic test was sold as validated medicine without the validation, in a market with no meaningful gatekeeper.

Regulatory Track

• The FDA and CMS should require that laboratory-developed genetic tests marketed with clinical outcome claims demonstrate those outcomes through registered, randomized, non-commercial trials before consumer sale, closing the validation gap this case reveals.
• Any accuracy figure in patient-facing materials should be required to state exactly what it measures (for example “per chromosome call”) in plain language, so “99% accurate” cannot stand in for a whole-embryo guarantee.
• As a general industry standard, patient education materials for medical add-ons should meet the CDC’s fifth-grade reading level requirement, which the cited assessment found none of the examined PGT-A materials met.

Legislative Track

• Legislatures should require that fertility add-on tests disclose the position of major professional bodies, such as the ASRM finding that the test’s value “has not been established,” at the point of sale.
• Consumer protection statutes like New York’s GBL 349 and 350 and the Illinois Consumer Fraud Act should be strengthened to explicitly cover material omissions in genetic and diagnostic marketing, the exact conduct alleged here.
• Lawmakers should mandate that any “improves outcomes” marketing claim be backed by randomized trial data, not by non-randomized in-house studies that the seller’s own researchers admit are “not sufficient.”

Corporate Governance Track

• Natera should be required to establish an independent scientific review board with authority to block marketing claims that outrun the company’s own evidence.
• Executive and sales compensation tied to add-on test volume should be restructured so that revenue growth cannot reward the marketing of unvalidated claims.
• The company should be required to fund the randomized, non-commercial trials scientists demanded for over a decade, or cease outcome-based marketing entirely.

What Now?

Direct your attention to Natera, Inc. and the agencies that let a decade of warnings go unenforced.

• Watchlist: The FDA (oversight of laboratory-developed tests), the FTC (deceptive advertising and material omissions), and state attorneys general in New York and Illinois enforcing the consumer protection laws cited in this complaint.
• If you purchased Natera’s Spectrum PGT-A test, you may be a member of the proposed Nationwide, New York, or Illinois class; document your payments, brochures, and consent forms.
• Connect with fertility patient advocacy and mutual aid networks that share unbiased, science-based information on IVF add-ons before you pay for one.
• Push your state legislators to mandate point-of-sale disclosure of professional-body positions on fertility add-on tests.
• Support independent, non-commercial reproductive research so patients are not left relying on the seller’s own marketing for the truth.