One Year After Lawsuits, PGT labs still on defensive. Providers Rely on Genetic Counselors
The Year After The Lawsuits
A series of class-action lawsuits filed in late 2024 and advancing in early 2025 placed preimplantation genetic testing for aneuploidy (PGT-A) under renewed scrutiny across the fertility field. The lawsuits alleged that several major testing companies overstated the accuracy and clinical value of PGT-A, leading patients to make irreversible decisions about embryos based on incomplete or misleading information. According to reporting by TIME, plaintiffs argued they were told the test would improve IVF success rates, reduce miscarriages, and speed time to pregnancy, despite scientific debate over whether routine PGT-A delivers those benefits for most patients. The suits claimed financial harm, emotional distress, and lost reproductive opportunities after embryos labeled “abnormal” were discarded or deprioritized.
The litigation drew attention to how genetic information is communicated to patients. As the cases moved forward in early 2025, the lawsuits put most legacy PGT labs on the backfoot, with many of them still failing to specify in what scientific improvements they are or are not investing. While many PGT labs have stopped publicly displaying their commitment to the fertility space, others are rising to the challenge.
“I heard some incredibly exciting talks [at ESHRE}”, Dr. Kate Devine, Chief Research Officer of US Fertility, told IRH. “The Juniper group, I'm really excited about the approach that they're taking by doing both the whole genome and whole transcriptome evaluation of embryos and specifically looking at variants that are known to be impediments to embryo viability and how they also are able to associate those variants in the parents”.
Devine added a word of caution to newer PGT labs that they don’t realize the same fate as some legacy PGT labs faced. “I just really hope that these groups, as much as there's this market pressure to become profitable, I hope that they validate [their claims] appropriately.
57% of Genetic Risks Were Missed in Routine Screening
After the lawsuits, experts pointed out how often high-impact findings can be overlooked without dedicated genetic expertise. In one study, 57% of patients had previously unrecognized risks, and 42% of those discoveries changed clinical management. Donor evaluation showed similar patterns: 84% of applicants disclosed new information during counseling, and 19% became ineligible under ASRM or program rules once that deeper review occurred.
Providers described wrong tests ordered, misinterpretation of variants, and cases where pathogenic findings were assumed to explain entire family histories. With embryo testing, probabilistic classifications such as mosaicism further complicate consent and transfer decisions.
Carrier panels now often exceed 700 genes, with heterozygous findings that require nuance, family studies, and tailored counseling. Providers called attention to the “Panel Paradox”: one lab’s “positive” may be another lab’s “negative,” creating confusion for both patients and physicians who must reconcile inconsistent variant classifications.
Additionally, patients increasingly arrive with direct-to-consumer genetic test results that must be reinterpreted—often corrected or re-contextualized—before influencing fertility decisions. As whole-genome sequencing and polygenic risk scores move closer to routine use, the interpretive burden is expected to accelerate further.
PGT-A Complexity Exposes Counseling Capacity Gaps
The legal developments amplified concerns already circulating within the fertility community about the growing complexity of genetic interpretation and the strain it places on clinical workflows. In public discussions over the past year, reproductive endocrinologists, like Dr. Jamie Grifo, and genetic counselors described how advanced testing—particularly PGT-A—can exceed the interpretive capacity of many clinics without specialized support, increasing the risk of miscommunication and legal exposure. Even practices with in-house counseling teams reported overload, while others relied on shared counselors across sites, raising concerns about consistency and documentation.
Dr. Grifo described patients' expectations plainly: “They expect us to be perfect,” a pressure intensified by expanding carrier panels, increasingly complex PGT decisions, and heightened legal scrutiny. Without proper counseling, the gap between what patients assume they have been screened for—and what has actually been interpreted—continues to widen.
Some groups, including CCRM, Shady Grove, and RMA utilize a firm called Gene-Screen’s genetic counselors as though they were in-house. CCRM’s Group Medical Director, Dr. Debbra Keegan, explained why. “GeneScreen provides world-class, accessible, genetic counseling that’s easy to interpret and exceptionally thorough. As an RE, I trust their guidance to help inform critical decisions about genetic risks, surveillance, and intervention.”
Clinics Network Clinics Report Counseling Bottlenecks and Workflow Strain
NYU Langone’s REI department employs three in-house genetic counselors and still managed more than 700 new patients in a single year. Other clinics sharing counselors across multiple locations reported delays, uneven documentation, and increased exposure when subtle family-history clues or variant nuances were missed.
RMA NY’s Dir. of Genetic Services Teresa Cacchione outlined the limitations of internal and lab-based counseling models: clinic staff are overwhelmed, low-risk carrier results frequently confuse patients, PGT consent requires deeper explanation, and reliance on lab panels risks missing critical context.
Clinical leaders described how structured genetic counseling support — both in-house and via third-party services like GeneScreen — helps fertility practices manage rising volumes and complexity. Dr. Shefali Shastri explained that her practice uses an in-house counseling team for single-gene cases and GeneScreen for broader panel interpretation to ensure patients understand clinically relevant results.
As genomic data expands and patient expectations rise, fertility centers are increasingly turning to genetic counselors that can plug into their teams. The challenges documented across networks suggest that workflow-integrated counseling is no longer optional—it is becoming central to safe, consistent fertility care.
“The ASRM ethics committee definitely has their work cut out for them this decade,” Devine said.
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