Diagnosis
Interview: predicting pregnancy complications before they happen
The founders of Mirvie are tapping into their expertise in RNA science and oncology to address gaps in maternal health with a platform that can predict pregnancy complications, such as preeclampsia, before they happen.
With 46,000 maternal deaths and 500,000 fetal or newborn deaths related to preeclampsia every year globally, there is an urgent need to tackle the burden of pregnancy complications.
Mirvie was founded to do just that, with the development of an RNA platform that can predict pregnancy complications before they happen.
RNA-based diagnostics utilise RNA molecules as indicators of disease or other conditions. Created over seven years, the platform uses a blood test to analyse RNA messages that impact pregnancy, revealing the unique biology of each one.
The platform has analysed over 15,000 pregnancies to date, and has been involved in several clinical studies, where it has been found to predict 90 per cent of pregnancies at risk of preterm preeclampsia and 60 per cent of babies with severe foetal growth restriction months in advance of delivery.
With plans for further research and to expand its global reach, Mirvie co-founder Maneesh Jain says the platform has the power to transform how we predict, prevent and treat unexpected complications.
Supporting pregnancy journeys
Jain and co-founder Stephen Quake founded Mirvie following their own pregnancy journeys, through which they discovered how quickly a routine pregnancy can result in an emergency C-section and a preterm birth.
“We wanted to make a difference for the next generation, because this is an area that has been left behind,” Jain tells Femtech World.
“There are some tests on the market that, once you are hospitalised with symptoms of preeclampsia, can diagnose if you are going to progress to a more severe disease or not.
“The challenge is that we don’t have any tests to predict and prevent the condition in the first place. So, our focus is preventive care, because once people develop symptoms, it’s too late.
“We can implement interventions such as delivering the baby early to save the mother, but that has a lot of adverse outcomes for both the mother and baby. I think moving to a preventive care paradigm is paramount in our minds.”
Preeclampsia is estimated to affect two to eight per cent of pregnancies worldwide, leading to 46,000 maternal deaths per year, and around 500,000 fetal or newborn deaths, according to the World Health Organisation.
“The statistics are pretty staggering, and preeclampsia is a challenging condition,” says Jain.
“We started with preeclampsia because it affects both the mother and the baby. There’s so much research now showing that if you have preeclampsia in pregnancy, it’s not just the childbirth process; it’s decades after that, you have a much higher risk of heart disease and stroke. So it’s really important to try to prevent these conditions in the first place, and so that’s our focus – to use our platform to detect molecular signatures of the condition.”
The platform is supported by a group of experts and is used in conjunction with a preventative care plan for pregnancies that have been flagged as at-risk.
“The preventive care plan includes medication and monitoring,” says Jain. “It may not in all cases stop the disease, but it certainly delays the onset of the condition, which is very helpful, because then the baby can be developing closer to term, and the mother can have less severe forms of disease.”
Harnessing RNA
Drawing from their background in advanced RNA science and oncology, where they had previously developed blood tests to detect cancer at the earliest stages, the pair wanted to make a difference to the modern pregnancy journey.
“Often, the approach to pregnancy is to hope for the best, and we’re largely in the dark on how things are developing,” says Jain.
“We used our background from oncology, using the idea that you can utilise RNA to tap into biology in a non-invasive manner and get a sense of what’s happening with the pregnancy.
“By looking at RNA, we can get an insight into how the development is proceeding and if it’s on track, or if it’s off track. What’s amazing is that we can now do it non-invasively with just a simple blood sample from the mother – you’re not taking a piece of the placenta or any tissue.”
Through its clinical research with a team of international collaborators, Mirvie showed that the RNA analysis could predict gestational age.
“Just by looking at the RNA signature in regular pregnancies, you can predict how far along you are,” explains Jain.
“Of course, we do it today with an ultrasound. But this finding was important because it showed that, with normal pregnancies, RNA is tracking the development very closely, and it can predict how far along you are.
“If there isn’t a predictable and changing pattern of RNA in normal pregnancies, then you really can’t look for deviations from that pattern.”
Jain says the test is already available in the US and can be obtained through telemedicine approval, with mobile phlebotomists that can take blood draws, which Mirvie then runs in its lab.
“We report the result to the patient, most often also to their treating OBGYN, and then if they happen to be positive, we put the action plan in place right away,” Jain says.
Mirvie now plans to expand globally and carry out further studies to help obtain insurance coverage for the platform.
“It seems there is a lot more innovation starting to happen in maternal health, and it’s much needed,” says Jain.
“Having worked across a few areas of medicine, I believe that this may be one of the greatest unmet medical needs that we have today, because the impact is lifetime for the mother, the baby, and the family.
“One of the things that is so important is awareness in this field, and to have more awareness of innovations in maternal health. I think that will change how much research is being done, how much investment is coming in, and how much better solutions we have that can truly advance the field.”
Mirvie was the winner of the Femtech World Maternal Health Innovation of the Year Award 2025. See the full winners list here.
Women with the same medical conditions as men were less likely to receive the same treatment across several specialties, a global research review found.
The review found differences in care for conditions including cardiovascular disease, kidney disease and Parkinson’s, with women less likely to receive some active treatments.
Of 38 studies analysed, 33 found women were less likely than men to be offered active treatment.
Researchers at the University of St Andrews found women with myocardial infarction, heart failure or an irregular heartbeat were more likely to receive medication, while men were more likely to undergo coronary bypass surgery, stenting or other surgical treatment.
Women were also less likely to be prescribed statins.
Men with Parkinson’s were more likely to be referred for deep brain stimulation.
Men with liver failure were more likely to receive a transplant, while women with kidney disease requiring dialysis were less likely to receive permanent access and spent longer using a catheter.
Women were also less likely to receive opioids for pain management.
The researchers found no significant difference between women and men in treatment for stroke or diabetes, while women were more likely to receive treatment for dementia.
None of the studies identified clinical guidelines recommending different treatment based on sex.
Researchers said this suggested the differences could not be explained by the need for different clinical approaches to women’s health.
Dr Andrew O’Malley, who co-led the study, said: “For clinicians, the findings are a prompt to check whether treatment is being offered on clinical grounds rather than assumption.”
He said studies showed doctors more often attributed women’s symptoms to anxiety and made more diagnostic errors with female patients, even when test results were positive.
Dr Miriam Veenhuizen, honorary lecturer in the School of Medicine at St Andrews, said: “While the direction of the findings was not a surprise, the consistency was. The same pattern appeared in cardiology, surgery, transplant medicine and emergency care, and it survived statistical adjustment in most studies.”
Menopause is often absent from women’s electronic health records, a study of nearly 396,000 women has found.
Researchers found menopause appeared almost seven times more often in participant surveys than in electronic health records (EHRs).
The findings suggest important reproductive health information, including age at menopause, may often be missing from health records used for research.
Audrey Hendricks, associate professor of bioinformatics at CU Anschutz and the study’s principal investigator, said: “Ultimately, we cannot study what we do not measure. We cannot treat what we do not know.
“Menopause has enormous implications for women’s health, but if we don’t consistently capture when menopause occurs and other important reproductive health information, we limit our ability to understand how this transition affects disease risk and health outcomes.”
Researchers at the University of Colorado Anschutz analysed data from women taking part in the National Institutes of Health’s All of Us Research Program.
They compared menopause information reported by participants in surveys with menopause diagnoses recorded in their electronic health records.
Around 193,000 menopause observations were identified in survey data, compared with approximately 28,000 diagnoses in EHR data.
Menopause was documented in electronic health records for only about 7 per cent of women in the dataset.
Nearly all participants with a menopause diagnosis recorded in their EHR also reported menopause in survey data. However, substantially fewer women had menopause documented in their health records.
Other important information was also frequently unavailable, including age at menopause, which researchers may use when examining links between menopause and chronic disease risk.
Menopause is a physiological transition that can affect cardiometabolic health and many other aspects of women’s health.
Researchers said relatively little is known about how factors including the timing and type of menopause influence health outcomes across diverse populations.
Large-scale programmes such as All of Us combine participant surveys, electronic health records and genomic data, but menopause-related research depends on relevant reproductive health information being available.
Missing menopause information can make it harder to investigate how the transition relates to health and disease.
The findings may also help researchers using All of Us data define menopause-related study populations, design studies and estimate how many participants are needed.
Hendricks said: “We have an enormous opportunity to use large-scale datasets to understand women’s health across the menopause transition and to identify who may be at greater risk for disease.
“But we need to make sure that the information researchers need is actually being collected.
“We must do a better job of capturing women’s health information, including reproductive health and measures related to menopause.”
Researchers said more complete and consistent collection of menopause and reproductive health information could help future studies examine factors such as age at menopause and their relationship with disease risk and health outcomes.
The FDA has granted accelerated approval to AstraZeneca drug Etcamah for certain adults with advanced breast cancer carrying an ESR1 mutation.
Etcamah, also known as camizestrant, was approved in combination with a CDK4/6 inhibitor, either abemaciclib, palbociclib or ribociclib.
The treatment is for adults with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer when an estrogen receptor-1 (ESR1) mutation is detected during aromatase inhibitor and CDK4/6 inhibitor therapy using an FDA-authorised test.
ESR1 mutations are acquired resistance mutations that tumours may develop during treatment with aromatase inhibitors, a type of endocrine therapy commonly used as a front-line treatment for locally advanced or metastatic breast cancer.
Fewer than 5 per cent of patients have the mutation when HR-positive metastatic breast cancer is diagnosed, according to the FDA. After disease progression on an aromatase inhibitor, nearly 40 per cent have the mutation.
Acting FDA commissioner Kyle Diamantas said: “Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment.
“We owe them every weapon in our arsenal.
“Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”
The accelerated approval programme allows earlier approval of drugs that treat serious conditions and fill an unmet medical need based on surrogate or intermediate endpoints.
For Etcamah, approval was based on how long patients lived without their disease worsening, measured from when the resistance mutation was first detected in their blood.
The FDA said it has not yet been confirmed whether intervening when the mutation is detected, rather than waiting until disease progression is confirmed, results in a clinically meaningful benefit. Confirmatory studies are therefore required to verify and describe clinical benefit.
Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said: “I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval.
“This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show that the disease is progressing.
“But additional evidence is needed to confirm clinical benefit.”
Circulating tumour DNA, or ctDNA, consists of small pieces of tumour DNA released into the blood and can allow earlier molecular detection of resistance mutations.
The FDA also authorised the Guardant360 CDx assay as a companion diagnostic to identify patients with breast cancer who have ESR1 mutations for treatment with camizestrant.
Efficacy was assessed in a clinical trial comparing a switch to Etcamah plus a CDK4/6 inhibitor with continued treatment using an aromatase inhibitor plus a CDK4/6 inhibitor.
Estimated median progression-free survival was 16 months in the Etcamah group, compared with 9.2 months in the aromatase inhibitor group.
Etcamah’s prescribing information includes a boxed warning about the risk of irregular heart rhythm when taken with certain other medicines. It also includes warnings about an abnormally slow heart rate and potential harm to an unborn baby.
The FDA convened its Oncologic Drugs Advisory Committee for the application on 30 April 2026.
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