Mirvie
Overview
Mirvie is a medical AI tool that utilizes a proprietary RNA platform to predict the risk of serious pregnancy complications. The platform analyzes tens of thousands of RNA messages from the baby, placenta, and mother using a simple blood test, combined with machine learning.
- What it does: The Mirvie RNA platform aims to predict complications such as preeclampsia, preterm birth, and fetal growth restriction months before symptoms appear by revealing the underlying biology of each pregnancy.
- Who it is for: This tool is intended for use by obstetricians, maternal-fetal medicine specialists, and other healthcare providers involved in prenatal care. It is designed to support proactive and personalized pregnancy management.
- How it fits a clinical or practice workflow: The Mirvie RNA platform involves a blood sample collected from the pregnant individual, typically between 18-22 weeks of gestational age for its Encompass test. Results are returned to the patient and their care team, accompanied by a preventive action plan and virtual assistant for support. This allows for discussions about potential interventions, such as increased monitoring or aspirin adherence, before complications escalate.
- Notable capabilities: The platform can predict preeclampsia and preterm birth months in advance. Its Encompass test for preeclampsia has shown the ability to predict 9 out of 10 pregnancies that later developed preterm preeclampsia as “high risk.” It has also identified unique molecular signatures predictive of severe fetal growth restriction. The Mirvie RNA platform has received CLIA certification for high-complexity clinical testing.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Cell-free RNA (cfRNA) platform
- AI and machine learning analysis
- Predicts preeclampsia months in advance
- Predicts preterm birth months in advance
- Predicts fetal growth restriction months in advance
- Simple blood test
- Reveals underlying biology of each pregnancy
- Personalized, predictive, and preventive approach to pregnancy care
- Encompassu2122 test for preeclampsia
- CLIA-certified laboratory
Use Cases
- Early detection of preeclampsia risk
- Early detection of preterm birth risk
- Early detection of fetal growth restriction risk
- Personalized prenatal care planning
- Proactive intervention for pregnancy complications
- Reducing lifelong health consequences for mothers and babies
What Physicians Need to Know
Evidence Base
Mirvie's RNA platform leverages advanced transcriptomic analysis with machine learning and AI to uncover the biology of developing pregnancies. [2, 17] The platform analyzes tens of thousands of RNA messages from the baby, placenta, and mother. [5] This approach aims to provide a fundamental understanding of each unique pregnancy's underlying biology, including complications. [3] Mirvie has published research in journals such as Nature Communications and the American Journal of Obstetrics and Gynecology. [2, 3, 4, 16]
Clinical Validation Studies
Mirvie has conducted the multi-center 'Miracle of Life' prospective study, which included data from over 9,000 pregnancies. [2, 7] This study was used to discover and validate RNA signatures for distinguishing between severe and mild hypertensive disorders of pregnancy (HDP), including preeclampsia, months before symptoms appear. [2, 7] The Mirvie RNA platform has been shown to predict preeclampsia and preterm birth months in advance. [4, 5] Specifically, a study published in Nature Communications in April 2025 demonstrated that Mirvie's blood test, Encompassu2122, can identify 91% of pregnancies that will develop preterm preeclampsia in women aged 35 and older without pre-existing high-risk conditions, months before symptoms. [2, 9, 24] The test also showed a 99.7% probability of not developing preterm preeclampsia for those with a low-risk result. [2] The platform has also successfully predicted 60% of babies with severe fetal growth restriction months in advance. [15, 18]
Alert Fatigue Management
While Mirvie's primary focus is on predictive testing rather than generating numerous alerts for existing conditions, its aim to provide early, precise risk assessment for preeclampsia and other complications could inherently reduce alert fatigue associated with reactive care models. By identifying high-risk pregnancies months in advance, clinicians can implement proactive, evidence-based prevention plans, potentially reducing the need for frequent, reactive alerts later in pregnancy. [2, 8, 9, 11, 17]
Differential Diagnosis Support
Mirvie's RNA platform helps differentiate between severe and mild hypertensive disorders of pregnancy. [2, 7] It has also identified unique RNA signatures for severe fetal growth restriction that are independent of preeclampsia, chronic hypertension, and gestational diabetes. [15, 18] This molecular understanding can aid in more precise differential diagnosis and personalized care. [2, 15, 18, 26]
Guideline Update Frequency
Mirvie is actively engaged in ongoing clinical research to validate existing peer-reviewed evidence, enhance its platform's performance, and improve the understanding of various pregnancy complications. [3, 6, 12, 16] This continuous research suggests a commitment to updating its knowledge base and potentially informing future guidelines. Mirvie has also enabled the publication of an evidence-based care plan for preeclampsia. [8, 12]
Clinical Workflow Integration
Mirvie's Encompassu2122 test is designed to integrate into prenatal care with a simple blood test. [2, 5, 9, 11] The results are paired with an evidence-based action plan to help reduce risk, which clinicians can review with patients. [9] The Encompass solution also includes a responsive virtual assistant for individualized support, medication check-ins, blood pressure monitoring, and alerts for patients when their numbers indicate a need to contact their clinic. [9] Mirvie has partnered with healthcare providers like Advantia Health to implement pilot programs using the Encompass test to initiate preventive care. [14]
Physician Tip
Mirvie's Encompassu2122 test offers a proactive approach to managing pregnancy complications like preeclampsia by providing early, personalized risk assessment. Utilize the test results to initiate evidence-based preventive care plans, including aspirin adherence and blood pressure monitoring, well before symptoms manifest. The accompanying action plan and virtual assistant can support patient engagement and adherence. This tool can help shift care from a reactive 'wait and see' model to a personalized, predictive, and preventive one, especially for patients without pre-existing high-risk conditions who may be missed by current guidelines. [2, 8, 9, 11, 17]
Mirvie's RNA platform is designed to provide predictive insights through a simple blood test, which can be integrated into existing prenatal care workflows. The Encompassu2122 solution includes a virtual assistant and patient-facing tools for risk tracking and alerts, suggesting potential for integration with patient engagement platforms or electronic health records (EHRs) for seamless data flow and communication. Mirvie is also exploring partnerships with healthcare providers to integrate its predictive testing into broader maternal health programs. [9, 14, 19]
Details
| Category | Clinical Decision Support & Reference, Lab & Diagnostics, OB/GYN AI |
| Pricing |
Unknown
|
| Deployment | Not applicable (laboratory service) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Unknown AI-estimated Mirvie received U.S. Food and Drug Administration (FDA) Breakthrough Device designation for its test to indicate a woman's individualized risk of developing preeclampsia before symptoms occur. |
| Integrations | |
| EHR | Not specified |
| Specialties | Laboratory Medicine, Maternal-Fetal Medicine, Obstetrics & Gynecology |
What the Web Says
Mirvie is a company developing an RNA platform and blood test (Encompassu2122) to predict pregnancy complications, particularly preeclampsia and preterm birth, months before symptoms appear. This approach aims to shift pregnancy care from a reactive to a proactive model, enabling earlier interventions and personalized care plans. The technology analyzes tens of thousands of RNA messages from the mother, baby, and placenta using machine learning and AI.
Overall: PositiveStrengths
- Early prediction of preeclampsia and preterm birth, allowing for proactive intervention.
- Utilizes a simple blood test, making it less invasive.
- Backed by landmark research and studies published in Nature Communications, demonstrating its efficacy.
- Potential to improve maternal and infant health outcomes by enabling personalized care plans.
- Physicians express a need for better tools to identify high-risk patients, and Mirvie's test is seen as a valuable solution.
- The Encompassu2122 test can identify 91% of pregnancies that will develop preterm preeclampsia in women aged 35+ without pre-existing high-risk conditions, with a 99.7% probability of not developing preterm preeclampsia for those with a low-risk result.
Limitations
- Limited information available from independent tech reviewers, G2, and Capterra, suggesting it may not be widely adopted or reviewed in those circles yet.
- Reddit discussions indicate that the test might be primarily for those without major pre-existing risk factors, and some high-risk individuals might already receive similar care without the test.
- As a startup, there's a risk of constant changes and potential layoffs, as noted in employee reviews.
- The direct-to-consumer model for the Encompass test is currently available for expecting mothers aged 35 and older without pre-existing high-risk conditions, limiting its initial accessibility.
- Some Reddit users question the necessity of the test for individuals already considered high-risk, as they would likely receive similar preventative care.
Based on reviews from: Contemporary OB/GYN, Indeed.com, Mirvie.com, Reddit, EurekAlert!, PRWeb, BioSpace, PR Newswire, PitchBook
Last updated: 2026-08-25
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Press & Coverage
Mirvie Press Releases
Mirvie Research at SMFM 2026 Advances Biological Understanding of Preeclampsia and Confirms Cost Savings Potential with RNA-Based Screening
Mirvie announced new research presented at the 2026 Society for Maternal-Fetal Medicine (SMFM) Annual Meeting, highlighting advancements in understanding hypertensive disorders of pregnancy and the economic value of RNA-based screening for preeclampsia.
2026-02
Mirvie Press Releases
Mirvie RNA Platform first to uncover unique molecular signal for babies at risk of severe fetal growth restriction
Mirvie revealed at the SMFM annual meeting that its RNA platform can predict severe fetal growth restriction, a major cause of stillbirth, months in advance by identifying a unique molecular signature.
2025-01
Mirvie Press Releases
Introducing Encompassu2122: A breakthrough solution from Mirvie to predict preeclampsia
Mirvie launched Encompassu2122, a new solution combining a blood test to predict personalized preeclampsia risk with a preventive action plan and virtual assistant for individualized support.
2025-05
Mirvie Press Releases
Mirvie Announces Results from Largest Molecular Study in Pregnancy and Clinical Validation of Simple Blood Test to Predict Risk for Preeclampsia Months Before Symptoms
Mirvie published a breakthrough study in Nature Communications, detailing new insights into hypertensive disorders of pregnancy and validating their blood test's ability to predict preeclampsia risk early.
2025-04
PR Newswire
WIN Expands Maternal Health Program and Introduces Early Preeclampsia Prediction and Prevention Program Powered by Mirvie's Encompass
WIN, a family-building and wellness benefits provider, expanded its maternal health solution, WINMaternity, through a partnership with Mirvie to offer the Encompassu2122 test for early preeclampsia prediction and prevention.
2025-07
TIME Magazine (Mirvie News)
The Best Inventions of 2025: Predicting Preeclampsia
TIME Magazine recognized Mirvie's Encompassu2122 Test for Preeclampsia as one of the best inventions of 2025, highlighting its ability to identify high-risk mothers before symptoms appear.
2025-10
Medtech Insight
Mirvie Granted Breakthrough Device Designation For Test To Identify Risk Of Preeclampsia
Mirvie received U.S. FDA Breakthrough Device designation for its blood test designed to indicate a woman's individualized risk of developing preeclampsia months before symptoms occur.
2022-05
Mirvie Press Releases
Study published in The American Journal of Obstetrics and Gynecology shows the Mirvie RNA Platform is first to predict preterm birth by revealing the underlying biology of each pregnancy
A study published in the American Journal of Obstetrics and Gynecology demonstrated that the Mirvie RNA platform can predict preterm birth months in advance by revealing the underlying biology of each pregnancy.
2022-04
Frequently Asked Questions
The Mirvie RNA Platform analyzes tens of thousands of RNA messages from the mother, baby, and placenta through a simple blood test to predict complications like preeclampsia, preterm birth, and fetal growth restriction months before symptoms appear. This objective assessment of risk, independent of demographics and clinical risk factors, provides an early detection window for physicians to intervene with personalized, preventive care plans.
The Mirvie RNA Platform has demonstrated its ability to identify 75% of pregnancies that later develop preeclampsia months in advance, with studies published in Nature. It also predicts preterm birth and severe fetal growth restriction, with research presented in the American Journal of Obstetrics and Gynecology and at the Society for Maternal-Fetal Medicine annual meeting. The Encompassu2122 test, powered by the Mirvie RNA Platform, can identify 91% of pregnancies that will develop preterm preeclampsia months before symptoms.
Current guidelines for preeclampsia prediction, which rely on maternal clinical and demographic characteristics, are often imprecise and weakly predictive. Mirvie's RNA platform offers a more objective and accurate risk assessment, helping to identify high-risk patients who might be missed by traditional methods. This improved risk stratification can promote and reinforce compliance with prophylactic interventions, such as daily aspirin, which currently has low adherence even among high-risk patients.
While other companies focus on personalized prenatal care, Mirvie differentiates itself with its focus on RNA sequencing to understand the unique biology of each pregnancy. Competitors mentioned include Aspira Labs, Vanadis Diagnostics, ProovTest, and ReproSource, which offer various women's healthcare and fertility diagnostic services.
The Mirvie RNA Platform is intended for use within the United States. The Encompassu2122 test is currently available for pregnant individuals who are at least 35 years old by their estimated due date, are less than 22 weeks pregnant when ordering, and can have blood drawn between 18-22 weeks. Patients with pre-existing conditions such as Type 1 or 2 diabetes, prior preeclampsia, chronic hypertension, renal disease, systemic lupus erythematosus, or antiphospholipid antibody syndrome are not eligible for the Encompass test. It's important to note that Mirvie does not provide medical advice or recommendations to alter prescribed treatment; results should be discussed with a healthcare professional.
Specific pricing details for Mirvie's tests are not publicly available in the provided search results. However, the Encompassu2122 test can be purchased directly online, includes a telehealth clinician review, and utilizes mobile phlebotomy for blood sample collection. Results are typically delivered within 10-14 days to both the patient and their provider care team, accompanied by a preventive action plan and a virtual assistant for support.
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| Last Verified: 2026-08-23 | First Added: 2026-08-23
Investors who backed Mirvie
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