- 2% to 8% of pregnancies worldwide are affected by preeclampsia, a leading cause of maternal and infant mortality.
- The SuperFlex system delivers results in as little as 14 minutes per test, enabling rapid clinical decision-making.
- The global preeclampsia diagnostics market is projected to reach over $5 billion by 2033.
Experts would likely conclude that Revvity's SuperFlex system represents a significant advancement in democratizing prenatal screening, particularly for smaller labs and clinics, by addressing key barriers of cost, accessibility, and operational complexity.
Revvity's Strategic Play to Democratize Prenatal Screening
WALTHAM, MA – August 10, 2026 – In a move that signals a significant shift in the landscape of maternal healthcare, health science solutions provider Revvity has launched its SuperFlex™ prenatal screening system. The compact, CE-IVDR certified instrument is engineered to bring high-quality, rapid testing for preeclampsia—a dangerous pregnancy complication—to smaller laboratories and local clinics that have historically been shut out from offering such advanced diagnostics.
This is more than a product launch; it's a calculated strategy to decentralize a critical aspect of prenatal care. Preeclampsia, a hypertensive disorder affecting 2% to 8% of pregnancies worldwide, is a leading cause of maternal and infant mortality. By targeting lower-volume workflows, Revvity is addressing a fundamental barrier to access that has left millions of women without adequate screening. The SuperFlex system aims to change that by making early detection both operationally and financially viable for a much broader range of healthcare providers.
"By removing the financial and operational barriers to in-house prenatal screening, we are giving more women access to potentially life-saving testing regardless of where they receive care," said Anna Godenhjelm, vice president and general manager of reproductive health at Revvity.
The Widening Gap in Maternal Health
The global health community has long grappled with the severe impact of preeclampsia. Characterized by new-onset hypertension after 20 weeks of gestation, the condition can rapidly escalate to cause organ damage, seizures (eclampsia), and death. For the fetus, it can lead to growth restriction and preterm birth. The urgency is amplified by a rising global prevalence, fueled by increasing maternal age and comorbidities like diabetes and hypertension. In the United States alone, hypertensive disorders of pregnancy complicated nearly 16% of all delivery hospitalizations from 2017 to 2019.
While international bodies like the American College of Obstetricians and Gynecologists (ACOG) recommend screening and preventative measures for high-risk women, the tools for early and accurate prediction have largely remained in the hands of large, centralized laboratories. Advanced first-trimester screening algorithms that combine maternal factors with biomarker analysis—specifically measuring placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1)—have proven superior in predicting risk. However, the high cost of the requisite high-throughput immunoassay analyzers and the operational complexity have made their widespread adoption prohibitive. This has created a stark divide in care, particularly impacting rural communities and healthcare systems in low- and middle-income countries.
Redefining the Diagnostic Workflow
Revvity's SuperFlex system is designed to dismantle these barriers through a focus on accessibility and efficiency. Its strategic value lies in three key innovations tailored for the decentralized lab environment. First is its accessible entry point. With an affordable instrument cost and a requirement of just one annual maintenance check, it dramatically lowers the capital expenditure and operational overhead. The system's design also ensures minimal reagent wastage, a critical cost-saving feature for labs with fluctuating and unpredictable sample volumes.
Second is its operational simplicity. The instrument's user-friendly interface is designed to minimize training time, a crucial advantage in settings that may lack specialized technicians. This ease of use is powerfully augmented by its seamless integration with Revvity’s LifeCycle™ software, a robust informatics platform that automates complex risk calculations and streamlines data transfer to Laboratory Information Management Systems (LIMS). This integration transforms a potentially complex process into a manageable workflow, allowing clinicians to focus on patient care rather than data management.
Finally, the system offers flexible throughput. By enabling continuous sample loading and delivering results in as little as 14 minutes per test, it can accommodate the dynamic needs of a local clinic, which must handle both routine appointments and urgent cases with equal efficiency. This rapid turnaround is essential for timely clinical decision-making, which can be life-saving in the context of a rapidly progressing condition like preeclampsia.
Carving a Niche in a Competitive Market
The launch of SuperFlex is a shrewd strategic maneuver within the burgeoning preeclampsia diagnostics market, a sector projected to reach over $5 billion by 2033. The space is currently dominated by industry giants like Roche Diagnostics, Siemens Healthineers, and Thermo Fisher Scientific, whose powerful, high-throughput systems—such as Roche's Elecsys® platform—are the mainstays of large hospital labs. Rather than competing head-on in the high-volume segment, Revvity is astutely targeting the underserved market of smaller labs and clinics.
This strategy aligns perfectly with the broader industry trend toward decentralized, point-of-care testing. By creating a solution that is compact, affordable, and easy to use, Revvity is not just selling a machine; it is enabling a new model of care. The SuperFlex system empowers local facilities to offer state-of-the-art screening in-house, improving patient access and strengthening the capabilities of community-based healthcare. This move positions Revvity to capture a significant share of a market segment its larger competitors have largely overlooked.
A Foundation for Global Expansion
The SuperFlex system's CE-IVDR certification provides a strong foundation for its market entry. This regulatory approval is not merely a box-ticking exercise; it signifies compliance with the European Union's new, more stringent In Vitro Diagnostic Regulation (IVDR), a globally respected benchmark for safety and performance. This certification grants immediate access to the entire EU and other regions that recognize the CE mark.
From this European base, Revvity plans a strategic expansion into the Asia-Pacific (APAC) region by late 2026. This move is consistent with the company's focus on high-growth markets and its existing operational footprint in key APAC hubs. The expansion is part of a broader portfolio optimization strategy, which includes divesting certain lower-growth assets to sharpen its focus on innovative, high-return opportunities like SuperFlex. By enhancing its well-established reproductive health portfolio, which already supports millions of prenatal and newborn screenings annually, Revvity is solidifying its leadership in diagnostics and reaffirming its commitment to leveraging technology to solve critical healthcare challenges.
