What a design defect taught us about science & integrity
A letter from our CEO, Adele Kazilsky
Genetic testing, and particularly carrier screening, sits at the very edge of what is scientifically possible today. It is one of the most advanced, delicate forms of analysis in modern medicine, requiring thousands of molecular interactions to perform perfectly. Because of its complexity, even the world’s most trusted global systems can present rare errors. Understanding this context is essential to understanding what occurred recently at FutureGen Labs.
In August 2025, our scientists identified an unexpected anomaly in one of our carrier-screening results. Instead of accepting it at face value, we followed protocol promptly: we notified and counselled the patient, issued a full refund, and arranged confirmatory testing through an independent accredited laboratory.
That single decision set in motion another, deeper review: one that ultimately revealed a subtle, but important design defect, in a genetic probe within the carrier-screening platform licensed to us by one of the largest, and most trusted, scientific companies in the world.
This defect caused false-positive signals in a very small subset of cases. Out of nearly one hundred carrier screenings performed since August 2024, only ten were affected. Every one of those patients were contacted personally, refunded in full, offered repeat testing through external laboratories at our cost, and supported throughout the process. Our investigation also confirmed that all the other remaining results were, without a doubt, scientifically accurate.
We halted all carrier screening immediately upon discovery of the design defect, brought in external experts, commissioned an independent investigation, and engaged directly with the manufacturer. This decision was made to protect our own patients in South Africa, but also, to alert the supplier, in effort to improve the accuracy of carrier screening at a global level.
It is important for us to state clearly that none of our other testing services were compromised in any way. Carrier screening tests require a unique and highly specialised assay that uses different machines, different chemistry, and different analytical programming to any other tests that we offer. All other services offered by FutureGen Labs remain accurate, robust, and unaffected. We encourage current, prospective, and past clients to continue booking any of our other tests with full confidence in their reliability as we participate in External Quality Assessments (EQA) annually.
Carrier screening itself is a frontier technology. It is not a diagnostic test; it is a screening tool designed to provide early insight, and like all frontier science, it carries a recognised margin of error. At FutureGen Labs, our carrier screening analyses 96 clinically significant conditions, as recognised by and based on the guidelines of the American College of Medical Genetics. Prior to launching this service, our scientists undertook extensive validations to ensure accuracy and reliability. Those same systems, which include our internal audits, checks, balances, and culture of scientific vigilance, are the very reason we identified this defect so early.
Following weeks of detailed investigation and data-gathering, we are now grateful to publish this full public account of what occurred, which includes a detailed FAQ sheet that outlines the more technical facts, the corrective measures implemented, and the steps we have taken to strengthen our systems going forward.
This is because we believe that transparency is not only an ethical obligation; it is a scientific one.
This experience has strengthened our processes, deepened our vigilance, and reaffirmed our purpose: to empower families with accurate, meaningful information about their health. To our colleagues across the genetics and fertility community, and to every family we serve: thank you for your trust.
FutureGen Labs remains the only ISO 15189:2022-accredited reproductive genetics laboratory in South Africa, and we will continue upholding that standard with humility, precision, and uncompromising integrity.
Not just for every patient today, but for the generations to come too.
Frequently Asked Questions
In more technical terms, what exactly happened with the recent carrier-screening defect?
In August 2025, our scientists identified an unexpected anomaly in a single carrier-screening result. We discovered a limited set of probe issues, which were identified in the system that was licensed to us for carrier screening analysis. For those who may be unaware, each mutation we screen for is covered by one or more specific probes. Our team discovered that a few of these probes were binding incorrectly to the wrong site and falsely indicating that the test sample provided was positive for a specific mutation.
Was this issue caused by FutureGen Labs?
No, our independent investigation confirmed that there was absolutely no negligence or medical malpractice on FutureGen Lab’s behalf. The incorrectly bound probes were due to a design defect in a third-party platform that was licensed to us.
What did FutureGen Labs do once the defect was identified?
Once the defect was identified, all carrier screening was halted immediately. Patients awaiting tests were refunded and notified. External experts were brought in, an independent investigation was initiated, and the manufacturer was engaged to address and verify the discovery.
Is FutureGen Labs still offering carrier screening?
Carrier screening is still on hold until further notice. We acknowledge the value and importance of the test and are working diligently with our supplier to determine the best way forward.
Were any screening results other than carrier screening impacted?
No, none of our other testing services have been compromised in any way. Carrier screening is a distinct, highly specialised test with its own machines, chemistry, and analytical programming.
How do I know if my carrier-screening result was affected?
All 10 affected patients were contacted, counselled, refunded, and supported by our team. If you were not contacted, your results were accurate and unaffected.
Can false positives cause harm?
False positives do not cause physical harm, but they may lead to emotional stress or anxiety. Thankfully, affected individuals later received the relief of accurate confirmatory results showing no increased risk.
What conditions does FutureGen Labs carrier screening normally test for?
Our panel includes 96 conditions such as cystic fibrosis, beta-thalassaemia, spinal muscular atrophy, Duchenne muscular dystrophy, and sickle cell anaemia, based on ACMG guidelines.
What actions is FutureGen Labs taking to prevent similar issues in the future?
We are working closely with the supplier to improve the platform, ensure design issues are corrected, and strengthen quality systems for future use.
Is carrier screening 100% accurate?
No test is 100% accurate. All screening tests have limitations, which is why genetic counselling and (if needed) confirmatory testing remain important parts of the process.
Could this defect have affected patients internationally?
Very likely—many labs globally use the same platform. This is why notifying the supplier was critical for improving global carrier screening accuracy.
How does FutureGen Labs evaluate and select the technologies used in testing?
We follow ISO15189 standards requiring validated assays, competent staff, serviced equipment, and strict measurement controls. These requirements apply across all services we offer.
How does FutureGen Labs differentiate between supplier issues and laboratory issues?
Supplier issues include design defects, faulty batches, or product quality problems. Laboratory issues include human error, competency problems, or negligence. The investigation confirmed this case was supplier-related.
What factors is FutureGen Labs considering before reinstating carrier screening?
We are assessing accuracy, ACMG alignment, South African population relevance, supplier reliability, regulatory compliance, and affordability to ensure the service remains both safe and accessible.
How will FutureGen Lab’s future carrier-screening model be strengthened?
We are working with the supplier to strengthen the platform globally. Updates will be published on our dedicated carrier-screening page as they become available.
Was FutureGen Labs compliant with ISO 15189 standards throughout this process?
Yes. All equipment was within range, staff were trained, reagents were compliant, and all testing was validated before being offered. Once the issue emerged, the ISO non-conformance route was followed immediately.
Why does screening sometimes require confirmatory testing?
Screening may show positive results even when no mutation exists, or miss certain changes. Confirmatory testing verifies results with more precise methods so patients and clinicians can make informed decisions.
If my partner and I want to be screened in the future, should we wait?
FutureGen Labs aims to build a population-specific dataset for South Africa. While our test is on hold, alternative suppliers are available. Contact the lab for guidance.
What does this mean for the future of carrier screening overall?
Carrier screening remains a vital tool in family planning to reduce hereditary disease transmission. We recommend screening particularly for couples with known genetic risks.
Who can I contact with questions or concerns?
You can reach us at 010 312 6576 or labs@futuregenlabs.co.za.