In the U.S., maternal mortality rates exceed most other developed countries, and a blood pressure pregnancy disorder called preeclampsia is one of the main contributors to this unfortunate statistic. Preeclampsia not only threatens the health of mothers and their babies during pregnancy, but it also increases the risk of cardiovascular disease for affected women later in life. For years, clinicians have sought to improve the clinical management of this disease; fortunately, a blood-based biomarker test that was designed to meet this crucial need was cleared by the FDA in 2023.
We are on the cusp of a new era ushering in personalized medicine for prenatal care, which shifts the focus in treatment from reaction to prevention. New tests for preterm birth and gestational diabetes are also in the pipeline and promise numerous benefits for pregnant mothers and their unborn babies.
However, in order to fully realize personalized medicine in prenatal care and leverage innovations such as the first-of-its-kind blood test that can identify pregnant women who are at imminent risk of developing a severe form of preeclampsia, broadening market access through reimbursement is paramount to ensure the test is widely available to anyone who would benefit from its use.
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Indeed, funding for research and reimbursement could present potential barriers. In this article, we will review the benefits of biomarker testing for maternal health and how nationwide legislative efforts already underway can help spur innovation and make personalized medicine a reality at the point of care.
Igniting innovation through legislation and funding
Through new legislation surrounding biomarker testing, we can fast track pathways to broaden the accessibility of biomarker testing. A nationwide effort is currently underway to expand insurance coverage and ensure patients who can benefit from personalized medicine can access it. As of today, campaigns are currently ongoing in nine states, and legislation has already passed in eighteen states. Biomarker testing is not just limited to preeclampsia — it can benefit a range of diseases and conditions such as cancer; and the targeted therapies have been shown to lead to better health outcomes.
Dr. Thomas McElrath MD, PhD in the Obstetrics/Gynecology department at Brigham and Women’s Hospital, has testified before several state lawmakers on how biomarker legislation can spur innovation and radically change obstetrics through precision prenatal care. “If it is difficult to get reimbursement for biomarkers, the ability for highly personalized pregnancy care is going to get torpedoed before it even gets out of the starting gate. This could inadvertently stifle medical advancement,” said Dr. McElrath, “It’s important to remove any legislative oversight restricting reimbursements for biomarker testing before the medical field has had a chance to use it for personalized medicine.”
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While more studies are conducted to demonstrate the advantages of Thermo Fisher’s biomarker test and its potential to help shape how preeclampsia is managed going forward, progress is being made in different parts of the country to fast track the use of the test in medical settings. In the state of Georgia, a biomarker bill (HB 85) passed, and this year more than $250,000 was put in the budget toward supporting resources like the preeclampsia test and funding to improve maternal outcomes in the state. Reimbursement for the preeclampsia test officially went into effect in Georgia on July 1st of 2024.
It is important to pave a pathway for reimbursement of the biomarker test across the country to ensure the new tool is accessible to hundreds of thousands of women diagnosed with preeclampsia every year in the U.S. Though progress is being made, the future of personalized medicine in preeclampsia care is largely dependent on the continued success of these legislative efforts to broaden market access to biomarker testing.
Advancing maternal health in the U.S.
While detecting biomarkers for preeclampsia is a new advancement in the U.S., the modality has been in use in the European Union for over a decade. As a result, many clinicians still are not aware of it in the U.S., but adoption is rising. Recently the American College of Obstetricians and Gynecologists (ACOG) issued new guidance around using the test in conjunction with standard clinical practices for diagnosing preeclampsia, encouraging doctors to learn about the biomarkers and better understand which patients should receive the test.
To further these advancements for prenatal care in the U.S., greater awareness is needed of these biomarker tests, in addition to funding to help support them. “I’ve already seen the impact these tests can have in a short amount of time, and I am committed to helping bring greater awareness to support broader adoption of biomarker testing for maternal health,” said Dr. McElrath.
Improving health economics and outcomes
Preeclampsia, which affects roughly 2% – 8% of pregnant women worldwide, causes high blood pressure and often prompts doctors to keep the patient in the hospital for close monitoring. At this time, the only treatment for severe preeclampsia is delivery of the baby. The new FDA-cleared biomarker test can assess whether a patient is at high or low risk of developing severe preeclampsia based on the risk-stratification ratio. When used alongside other diagnostic measures, the test can tell who will develop preeclampsia with severe features within the next two weeks – allowing doctors to make more informed treatment decisions including safely prolonging pregnancy.
“Medical students are taught that once a patient is diagnosed with preeclampsia, she needs to stay in the hospital for at least 24 hours, if not 36 to 48 hours. But when patients learn of this, often they look at you like you’re crazy because they feel fine. I have found the test to be extremely helpful because it has allowed me to help determine which patients are at a high risk for progression and it allows me to have more confidence in my decision to keep them in-patient at the hospital,” said McElrath.
This can ultimately have a large impact on NICU rates and cost associated with treatment. In fact, according to a study, the estimated cost of preeclampsia within twelve months of delivery is $2.18 billion ($1.03 billion for mothers and $1.15 billion for infants), much of it attributed to births of low gestational age. That same study showed that the probability of having an adverse event during pregnancy increased from 4.6% to 10.1% for those mothers with preeclampsia – strong evidence that having better screening tools can significantly improve health economics and outcomes.
Dr. McElrath said reducing both maternal hospitalization and NICU stays is a huge benefit and frees up more beds for hospitals that are already financially vulnerable and dealing with shortages and capacity challenges.
Making personalized medicine a reality
Personalized medicine is critical to addressing pressing maternal health issues such as preeclampsia, one of the leading causes of death in pregnant women. But new advancements can only be fully realized when clinicians, lawmakers, and patients come together. Biomarker tests not only have the potential to improve patient outcomes and address health equity, they can also decrease expenses for financially vulnerable medical systems. We need to raise awareness and promote the adoption of the new preeclampsia test within the OBGYN community and among lawmakers, emphasizing the crucial role biomarkers play in tackling broader maternal healthcare challenges.
Disclosure: Dr. Woodham and Dr. McElrath are both paid consultants of Thermo Fisher Scientific.
Photo: Aleksei Naumov, Getty Images
Dr. Padmashree “Champa” Chaudhury Woodham is a Professor of Maternal-Fetal Medicine, MFM Fellowship Program Director at the Medical College of Georgia, and Director of the Regional Perinatal Center at Wellstar MCG Health. She earned her MD from Emory University, where she also completed her OB-GYN residency. She completed her MFM fellowship at UNC Chapel Hill. Board certified in both OB-GYN and MFM, Dr. Woodham spent a decade at Mercer School of Medicine as Director of MFM, taking on multiple leadership roles and earning honors like the ACOG/CREOG National Faculty Award. She was also the 2022-2023 President of the Georgia OBGYN Society. Dr. Woodham provides specialized high-risk obstetric care, including EXIT procedures and fetal shunt placements. Her research focuses on predictive markers for preeclampsia and improved methods for identifying growth restriction on fetal ultrasound.
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