Sera Prognostics
NasdaqGM:SERA
$
2,22
$
+
$0,06 (2,78%)
2,22
$
+$0,06 (2,78%)
End-of-day quote: 04/08/2026
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Sera Prognostics Company Info
EPS Growth 5Y
36,63%
Market Cap
$0,09 B
Long-Term Debt
$0,00 B
Short Interest
3,43%
Annual earnings
N/A
Dividend
$0,00
Dividend Yield
0,00%
Founded
2008
Industry
Country
ISIN Number
Website
Analyst Price Target
The Analyst Price Target shows the analysts’ low, high, and average target at a glance.
$5,00
125.23%
Last Update: 04/07/2026
Analysts: 1
Highest Price Target $5,00
Average Price Target $5,00
Lowest Price Target $5,00
In the last five quarters, Sera Prognostics’s Price Target has risen from $2,75 to $2,75 - a 0,00% increase. Two analysts predict that Sera Prognostics’s share price will increase in the coming year, reaching $5,00. This would represent an increase of 125,23%.
Top growth stocks in the health care sector (5Y.)
What does Sera Prognostics do?
Sera Prognostics, Inc. is a women’s health company.
The company is utilizing its proprietary proteomics and bioinformatics platform, and significant data resources to improve maternal and neonatal health by discovering, developing, and commercializing blood-based biomarker tests, and predictive analytic products and services. The company’s method of combining the disciplines of proteomics and bioinformatics with rigorous clinical testing, data, and economic analysis enables it to provide physic...
Sera Prognostics, Inc. is a women’s health company.
The company is utilizing its proprietary proteomics and bioinformatics platform, and significant data resources to improve maternal and neonatal health by discovering, developing, and commercializing blood-based biomarker tests, and predictive analytic products and services. The company’s method of combining the disciplines of proteomics and bioinformatics with rigorous clinical testing, data, and economic analysis enables it to provide physicians and expectant mothers with personally insightful, clinically meaningful, and economically impactful information designed to improve the pregnancy experience and outcomes for mothers and babies.
The company has built an advanced, proprietary, and scalable proteomics and bioinformatics platform to characterize the biology of pregnancy and to discover and validate key protein biomarkers found in blood that are highly accurate predictors of dynamic changes that occur during pregnancy. By incorporating the company’s proprietary technology platform into its rigorous data-driven development process, it has created a differentiated approach for effectively addressing major milestones, conditions, and features of pregnancy. The company’s large and growing pregnancy dataset (clinical, demographic, and proteomic) is a substantial asset for understanding pregnancy complications, health inequities, and the personal pregnancy journey.
The company’s first commercial product, the PreTRM test, is the only broadly validated, commercially available blood-based biomarker test to accurately predict the risk of a premature delivery, also known as preterm birth. The PreTRM test is a non-invasive blood test given to a pregnant woman, carrying a single fetus, during weeks 18 through 20 of gestation that provides an accurate prediction of the expectant mother’s risk of delivering spontaneously before 37 weeks’ gestation. The company’s commercialization strategy focuses on demonstrating the health and economic benefits of early and accurate detection of preterm birth risk coupled with well-recognized interventions in higher risk patients, illustrating these benefits to healthcare providers and insurance payers, and providing convenient access to the test through streamlined specimen collection options. Clinical trials conducted as of December 31, 2024 included the Prediction and Prevention of Preterm Birth, or the PREVENT-PTB Study, Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls study, or the AVERT PRETERM TRIAL, and the Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs study, or the PRIME study.
In July 2024, the company announced the publication of the positive results from the AVERT PRETERM TRIAL in Diagnostics, an international, peer-reviewed, open access journal on medical diagnosis.
In December 2023, the company announced that the Data Safety Monitoring Board, or DSMB, overseeing its PRIME study recommended stopping enrollment due to efficacy, reporting that either co-primary endpoint, neonatal hospital length of stay and composite neonatal morbidity and mortality, met the stopping criteria for statistical at the pre-planned interim analysis. The company adopted the DSMB’s recommendation and stopped the PRIME study enrollment to focus on analyzing and reporting the available data.
The company’s studies support a strategy were identifying and intervening in higher-risk pregnancies, not identifiable by traditional or standard approaches, can allow babies who were destined for premature delivery to remain in utero longer. This prolongation of gestation in the preterm period can lead to more mature babies that require shorter hospital/NICU stays due to improved neonatal health.
Beyond demonstration of clinical study efficacy, the company looks forward to studying the effectiveness and implementation of the PreTRM test in a real-world setting. The company’s real-world evidence implementation programs, targeting to expand PreTRM clinical utility data and replicate randomized controlled trial evidence in the real world, has been developed for study launches anticipated in early 2025.
The company is actively discovering and developing additional biomarker tests to predict other specific major conditions of pregnancy, such as a pregnancy risk prediction panel test. Among other products, the company is developing a lifestyle test designed to provide a more accurate estimate of the delivery date for expectant mothers for the purposes of planning maternity leave, family support, travel arrangements, and related considerations.
Proprietary Technology Platform
The complexities of the biology of pregnancy have been a major obstacle in developing effective tests for pregnancy-related conditions. The company is working to overcome this obstacle through its development of a proprietary technology platform consisting of biobanks, advanced mass spectrometry, immunoassays, and other proteomic analytic methods and bioinformatics, which enables superior characterization of the biology of pregnancy and more accurate prediction of pregnancy outcomes.
An analysis of protein pathways and expression at various points during pregnancy reveals dynamic changes affecting both the mother and the baby. Earlier detection of changes in protein expression indicating the emergence of adverse pregnancy outcomes can enable proactive management of those conditions A fundamental component of the company's platform is its proprietary biobank, consisting of comprehensive, clinically and demographically annotated specimens collected from thousands of pregnant U.S. women, representing the broad demographic and geographic diversity inherent in the U.S. population. This differentiated resource enables the company to develop and broadly validate its predictors. Further biobank diversity is also provided through its scientific collaborations with leading maternal-fetal medicine experts around the globe, enabling the analysis of specimens collected from patients in the United States, Europe, Asia, and Africa. In strict adherence to the authoritative National Academy of Medicine, or NAM, guidelines, the company applies its innovative mass-spectrometry and other proteomic analytical methods, as well as its knowledge of protein information networks, to probe biobank specimens for meaningful protein expression changes. It then subjects the data to inventive bioinformatics analysis and uses advanced tools, such as machine learning and artificial intelligence, to find relationships between various proteins and to discover important predictors.
Discovery, Development, and Commercialization Approach
The company’s product discovery and development approach are based on rigorous science and health-based economic analyses as the company discovers, develops and commercializes biomarker tests and predictive analytic products and services designed to transform pregnancy-related care for patients, doctors and payers. The company has initially applied its platform and capabilities to address the problem of preterm birth, given its profound health and economic impacts worldwide. The company’s development and commercialization strategy also involve transitioning some products from proteomic discovery platforms (such as mass spectrometry) to immunoassays. Technology development also includes removing bottlenecks in specimen collection and shipment by use of whole-blood collection and ambient shipping.
The company uses the following multifaceted approach in its research, development and commercialization efforts:
Significant Unmet Need: The company selects specific conditions or features of pregnancy that are clinically and personally meaningful and economically important and with significant unmet needs that lack effective solutions. The company intends to explore other areas of significant unmet need in pregnancy, including preeclampsia, gestational diabetes and others.
Proteomic and Bioinformatics Platform: The company utilizes its platform to understand the biology underlying selected pregnancy-related conditions to discover, verify, and broadly validate high-performing predictive biomarker tests and predictive analytic products and services. Its various studies and other research have endowed the company with an extensive biobank of blood samples that provide a deep view into the care and outcomes of diverse singleton pregnancies across the United States, enabling the prediction of various other outcomes. The company is continuing to conduct analyses of its growing biobank of data from multiple sources to provide new insights that will be the basis of discovering and developing biomarker predictions for a variety of important conditions of pregnancy.
Immunoassays: The company identifies antibodies to discovered pregnancy biomarkers and develop immunoassays for use in its own or other CLIA laboratories, including the potential for eventual use in ex-U.S. territories.
Blood Collection, Logistics and Processing: The company evolves its draw windows, sample types, collection techniques, and lab processes to enable greater access to its tests, ease of use for providers and patients, and cost-effectiveness for its products to scale.
Demonstration of Health and Economic Impact of the company’s Test and Treat Strategy: A critical element of the company’s success will be to demonstrate the beneficial health and economic impacts of using the information provided by its biomarker tests. In the case of the PreTRM test, the company’s commercialization strategy involves amassing clinical and economic data to definitively demonstrate that detecting a mother’s risk of preterm birth can enable proactive interventions, which improve her health and her baby’s, while at the same time saving substantial health care system costs. The company’s rigorous, controlled intervention trials, PREVENT-PTB, AVERT PRETERM TRIAL and PRIME, evaluated the company’s test-and-treat strategy in a total of more than 7,000 patients enrolled in the treatment arms. The company has published multiple peer-reviewed papers supporting clinically beneficial results from PREVENT-PTB and the AVERT PRETERM TRIAL, and presented positive results from the PRIME study at the 2025 SMFM Pregnancy Meeting, and the company is actively working toward peer-reviewed publications for the PRIME study.
The company also works with leading health economists and organizations to build rigorous models that describe how application of the PreTRM test-and-treat strategy impacts both health and economic outcomes. The company works to publish models that provide peer reviewed evidence of the value of its strategy.
Pipeline
The company is developing a robust pipeline of novel blood-based biomarker tests for a number of major pregnancy related conditions beyond preterm birth by leveraging the biological insights provided by its proprietary technology platform. The company’s product candidates are designed to accurately predict and enable better management of a range of serious pregnancy-related conditions. These product candidates, if successfully developed, have the potential to address significant unmet needs by providing more accurate prediction of these pregnancy-related conditions and providing patients with meaningful information and physicians with earlier opportunities for intervention.
Strategy
The company’s strategies are to expand payments for the PreTRM test to a variety of market segments and payment models to maximize the commercial opportunity; apply the company’s platform capabilities to broaden its pipeline and develop novel and high-performing products for pregnancy-related conditions and potentially other health conditions; continually enhance the value and capabilities of the company’s proprietary technology platform through ongoing expansion and integration of the company’s biobank and its proteomics and bioinformatics databases; evolution of the company’s testing, specimen collection and shipping technologies; continue building an evidence portfolio of clinical and economic outcomes driven by the company’s products; engage with professional societies; partner with employers to expand the payer mix for the company’s products; complement its products with a potential care coordination offering; build a women’s health commercial infrastructure; evaluate strategic partnerships to maximize the value of the company’s product offerings; and build long-term relationships with the company’s expectant mother customers to support their pregnancy journeys.
Proprietary Technology Platform
The company’s proprietary proteomic and bioinformatics technology platform has the potential to enable critical advances in the management of pregnancy and its outcomes. The company’s platform consists of biobanks, advanced mass spectrometry and other proteomic analytic methods and bioinformatics, which enables superior characterization of the biology of pregnancy and accurate prediction of pregnancy outcomes. The company’s platform, built on differentiated tools and capabilities, provides pregnant mothers and their doctors more clinically meaningful and economically impactful predictions of adverse pregnancy outcomes to enable more timely intervention and improve the well-being of both mother and baby.
The company’s large proprietary U.S. biobank resource was built by collecting blood from thousands of comprehensively annotated blood specimens from patients, which cover a broad range of gestational ages and represent the broad demographic diversity and geographic distribution of pregnant women across the United States. The company collected the specimens in two large multi-center trials: its PAPR study, beginning in 2011, and the company’s TREETOP study, beginning in 2016. These two studies prospectively collected specimens, together encompassing weeks 17 through 28 of pregnancy, from women carrying a single baby, and, as ‘all comers’ studies, collected information on a variety of important pregnancy outcomes, including preterm birth, preeclampsia, gestational diabetes and other conditions. These specimens and their associated data are carefully analyzed to discover and develop informative biomarker signatures for intended use pregnancy populations. The company continuously works to add new specimens to its biobanks in additional studies, generating greater opportunities for ongoing development of clinically meaningful and economically impactful biomarker predictions.
The company's work on proprietary biobanks has established it as a leader in proteomic approaches to characterize pregnancy. The company also conducts bioinformatics analyses on additional specimens from other institutions in the United States and abroad. The company analyses each specimen by conducting proteomic and other measurements in its laboratory, which generates large sets of biomarker data for each specimen. Through the analysis and evaluation of biomarkers with advanced bioinformatics approaches, it discovers novel predictions for various adverse pregnancy outcomes. The company is then able to apply these predictions to non-overlapping independent specimens from different biobanks available to it to confirm and validate the accuracy and performance of the predictions.
The company adds to its biobanks on an ongoing basis by continuously analyzing larger numbers of specimens from its own sponsored studies, as well as those from collaborations with maternal-fetal medicine leaders around the world. The company has validated proprietary biomarker signatures consisting of proteins and clinical variables in specimens collected from the United States, Europe, Asia, and Africa. As its database and sets of predictions grow, verifying and validating the predictions can lead to more rapid and efficient development required to commercialize such predictions in the future.
Advanced Mass Spectrometry Approaches
The company has developed and applied innovative state-of-the-art mass spectrometry techniques to screen and detect in its bio-specimens the dynamic changes in protein expression occurring in normal and abnormal pregnancy development. The company’s proprietary proteomics workflows enable detailed and efficient measurements of hundreds of proteins simultaneously from complex matrices, such as blood. The company also utilizes a variety of other screening techniques to explore and understand the pregnancy proteome, including large- and small-scale immunoassay screens, other ligand-binding assays and RNA analyses, among others. To ultimately validate biomarker performance, the company translates and confirms, on its mass spectrometry platform, the findings that the company has generated with these other analytical measurement technologies. The company’s rich and extensive database of omics data, combined with highly annotated clinical information, is analyzed by state-of-the-art bioinformatics capabilities.
Through the company’s innovative approaches and advances in proteomics, it has discovered and validated meaningful predictions for adverse pregnancy outcomes. Importantly, the company’s mass spectrometry process is well-suited not only for discovery and development activities, but also for high volume commercial production using robotics and automation. Mass spectrometry measurements can be performed on very small blood volumes, which is appealing for patient specimen collection and can lower cost of goods in laboratory analyses. The company endeavors to remain at the forefront of the clinical application of mass spectrometry-based proteomics by making advancements in specimen collection, shipping, and laboratory processes. Its specific applications of mass spectrometry-based proteomics can be scaled to efficiently and cost-effectively accommodate the growth that it anticipates in addressing the large pregnancy testing market.
The company is continually enhancing its analytical techniques. This includes improving customer experience with the identification and validation of whole-blood collection devices, ambient specimen shipping, and laboratory process changes. The company continually refines the laboratory process to make it more efficient, lower costs, and improve turnaround time, or TAT. It continues to evaluate additional antibodies to PreTRM analytes for the potential development of sandwich immunoassays (e.g., ELISA) or clinical analyzer-compatible assays.
Advanced Bioinformatics
The company has assembled a powerful collection of advanced bioinformatics capabilities as a critical component of its platform. Bioinformatics is an essential field of science in which biology, statistics, advanced computational science, and information technology are combined to systematically and comprehensively analyze complex biological information. The advanced bioinformatics tools that the company applies at great scale to measurements conducted on its biobank specimens to develop high-performing, important predictive algorithms include, but are not limited to, machine learning, artificial intelligence, causal inference, supervised learning methods, dimensionality reduction methods, and advanced statistics. As a result of rigorously applying its core expertise and proprietary approaches in bioinformatics, the company has discovered high-performing algorithms that reliably distinguish pregnancies with normal protein expression from those showing disordered protein expression. Deep bioinformatics insights into the biology of pregnancy have enabled the company to discover, verify, and validate important predictions of adverse pregnancy outcomes.
The company has built an experienced discovery and development team with the deep expertise in science and mathematics necessary to perform rigorous bioinformatics analyses. It strictly adheres to the authoritative guidelines published by NAM on how to reliably develop and validate omics predictions made on complex biological data sets. These guidelines require disciplined validation of predictions to ensure the validity and reliability of such predictions before they can be used clinically or commercially. The NAM guidance calls for pre-specifying how the predictions are to be made and then applying testing in completely independent specimen cohorts, to be certain that the predictions are valid. Adhering to these guidelines, the company has been able to validate that a number of its adverse pregnancy predictors are replicable in independent cohorts of patients residing in the United States, Europe, Asia, and Africa.
The PreTRM Test — Solution for Preterm Birth
Utilizing its product discovery, development, and commercialization approach, and in view of the stark realities of preterm birth, the company focused its first development and commercialization efforts on addressing preterm birth. The company’s first product, the PreTRM test, is the only broadly validated, commercially available blood-based biomarker test to accurately predict the risk of spontaneous preterm birth. In addition to traditional phlebotomy for obtaining a patient specimen, the company recently validated and added a whole-blood collection kit option that utilizes the less invasive fingerprick method of collection. The company has contracted with a Food and Drug Administration-registered supplier to produce its branded kit under applicable quality systems requirements and has begun making the kit available at a limited scale. Whether the patient's blood specimen is collected via phlebotomy methods or by using the collection kit, the specimen is then sent to and analyzed in its CLIA-certified clinical laboratory using high-throughput mass spectrometry technology.
In addition, the company continues to build on its existing data to further demonstrate the clinical and economic benefits of intervening based on PreTRM test results. The accuracy of the PreTRM test has been rigorously assessed and validated in its PAPR study involving 5,501 women in 11 obstetric centers across the United States. The completed PAPR study validated the biomarker signature, which is highly predictive of spontaneous preterm birth risk. The company and its collaborators have completed three prospective controlled intervention studies—PREVENT-PTB, AVERT PRETERM TRIAL, and PRIME—to demonstrate the value of identifying higher-risk pregnancies coupled with proactive interventions to improve the well-being of mothers and newborns.
The company’s comprehensive approach to build evidence for the company’s PreTRM test addresses key elements payers require in order to reimburse testing, including: analytical validation of the testing platform, or measurement validity; clinical validation, or test validity; clinical utility of using validated predictions, or positive health benefit; and economic utility, or cost effectiveness and health care savings.
The strength of the data from the company’s studies of the PreTRM test has enabled it to pursue an accelerated approach to commercialization. Elevance Health, whose health plans cover more than 10% of the U.S. pregnancies annually, agreed to pay for the company’s PreTRM test for eligible pregnant members as part of a multi-year contract. The collaboration also enables the company to generate more data to demonstrate the value of the PreTRM test and treat approach across diverse patient populations within Elevance Health’s insurance plans.
Biomarker Discovery and Clinical Validation of the PreTRM Test
Adherence to National Academy of Medicine Guidelines
The company rigorously adheres to authoritative NAM guidelines published in 2012 for developing and validating multi-omics predictions and applying important principles to address adverse conditions that arise in pregnancy.
PAPR Study
The initial discovery, verification and validation of the company’s spontaneous preterm birth biomarker risk predictor was performed in the 5,501 patient Proteomic Assessment of Preterm Risk, or PAPR, study.
TREETOP Study
The company’s second large clinical validation study, A MulTicenteR AssEssmEnt of a SponTaneOus Preterm Birth Predictor, or TREETOP, enrolled patients beginning in October 2016 with the last delivery occurring in May 2019.
Prospective Intervention Studies — Demonstrating the Benefits of the PreTRM Test and Treat Strategy
Following the validation of predictors for spontaneous preterm birth, the company sets out to demonstrate the value of identifying higher-risk pregnancies coupled with proactive interventions to improve the well-being of mothers and newborns. The company has worked with respected collaborators to conduct three prospective intervention studies to demonstrate the clinical utility and economic value of the PreTRM test and treat approach.
PREVENT-PTB Study
The Prediction and Prevention of Preterm Birth, or PREVENT-PTB, study (Clinical trials identifier: NCT03530332) was a prospective randomized controlled intervention study conducted at Intermountain Healthcare in Salt Lake City, Utah. The PREVENT-PTB study enrolled a total of 1,208 patients to evaluate the health and economics impact of applying the PreTRM test.
AVERT PRETERM Trial
On February 15, 2023, the company announced that both co-primary outcomes—reduction of severe neonatal morbidity or neonatal death; and decreased length of neonatal hospital stay—met their endpoints, and the improvements in outcome with a PreTRM test-and-treat approach were statistically significant.
PRIME Study
In collaboration with Elevance Health, the company is conducting Prematurity Risk Assessment Combined with Clinical Interventions for Improving Neonatal outcoMEs, or PRIME (Clinical trials identifier: NCT04301518), study, which is a prospective randomized controlled study anticipated to enroll up to 6,500 pregnancies in 19 respected maternal fetal medicine centers. The company began enrollment in November 2020. In December 2023, the company announced that the Data Safety Monitoring Board, or DSMB, overseeing its PRIME study recommended stopping enrollment due to efficacy, reporting that either co-primary endpoint, neonatal hospital length of stay and composite neonatal morbidity and mortality, met the stopping criteria for statistical significance at the pre-planned interim analysis. The company adopted the DSMB’s recommendation and stopped PRIME study enrollment to focus on analyzing and reporting the available data.
Product Pipeline
While the company has leveraged its technology platform to pursue the development and commercialization of the PreTRM test, its technology platform has broad applicability across a wide array of pregnancy-related conditions. The company and its clinical trial collaborators are also continuing to conduct analyses by combining biobank data from the PAPR and TREETOP studies, to provide new insights into the predictive capabilities of the PreTRM test and other predictive biomarker algorithms. It is discovering, developing, and validating a broad portfolio of product candidates.
When the company refers to ‘discovering, developing, and validating’ its product candidates, it is referring to the three phases of work for the development of predictive tests as published in the NAM guidelines, as summarized below.
In the ‘discovery’ phase, the company analyzes a set of biologic specimens from patients whose pregnancy outcomes are already known to find biomarker differences between individuals who had an adverse pregnancy outcome versus individuals who did not have an adverse pregnancy outcome (e.g., pregnancies that delivered preterm versus pregnancies that lasted to term). The company then builds predictive algorithms, based on high performing predictions, to be tested in the next phase.
In the ‘verification’ phase, the company applies the high performing predictive algorithms selected during the discovery phase to a completely independent set of new biologic specimens that were not tested during the discovery phase. An independent, external statistician then verifies, or confirms, the performance of the algorithms, and ranks them according to predictive accuracy. Once they are verified through this process, the highest performing algorithms are ‘locked down’ in the form of optimized tests that can be validated in a final phase, prior to commercialization.
In the ‘validation’ phase, a third, entirely independent set of biologic specimens that were not tested during either the discovery phase or the verification phase are tested in a laboratory, with the laboratory blinded to patient outcomes. The laboratory data are time-stamped and are transferred to an external statistician, who applies the pre-specified algorithms to the laboratory measurements and independently validates the performance of the test by breaking the blind. At this point, a prediction that has been independently and rigorously validated can be used for clinical decision-making in trials and/or commercialization.
Molecular Time-to-Birth
Problem and Need: The company has already developed a high performing biomarker signature in its PreTRM test for spontaneous preterm birth risk. For a pregnant woman who is not at higher risk of preterm birth by the company’s PreTRM test, she would typically like to know how much time is remaining in her pregnancy until delivery. The company has identified biomarker signatures that predict the time remaining in a pregnancy with greater accuracy than is available from methods.
Development Status: Using the company’s proprietary biobanks and proteomics platform, it has discovered and verified biomarkers with superior time-to-birth predictive performance, as compared to dating methods. The company has developed the ability to determine more precisely how much time is remaining in a woman’s pregnancy based on her individual biology at the time of her blood draw. The company is exploring the optimal commercialization strategy of a molecular time-to-birth predictor. A manuscript entitled: Clock Proteins Have the Potential to Improve Term Delivery Date Prediction: A Proof-of-Concept Study was published in the journal Life on February 3, 2025.
Predictive Analytics
Problem and Need: As the company has accumulated tens of thousands of highly curated pregnancies in its databases, the application of machine learning has opened the potential for predictive pregnancy analytics that give insight on many critical aspects of pregnancy that are relevant to both the mother (e.g. planning, expectations, education) and her physician (e.g. risk assessment, management planning).
Objective for a Predictive Analytics Tool: The company is working to develop a predictive analytics product that can be used in combination with its clinical tests, or on its own, as a tool to understand various features and conditions of pregnancy, for both the benefit of the mother and physician.
Development Status: The company recently developed the LikeMine webapp. This product allows a user to input her health and demographic information, compares that information to large public and private databases, groups the user with a cohort of women with the same or similar health and demographic characteristics, and reports incidence levels of various pregnancy events and outcomes for that cohort at a greater level of specificity than nation-wide statistics. LikeMine is available on the internet as the company conducts beta testing.
Pregnancy Risk Prediction Panel
Condition: Up to 31% of pregnancies will develop a significant complication. Furthermore, traditional clinical risk factors miss two-thirds of these complications. The intended use of the pregnancy risk prediction panel is to identify those pregnancies at high risk of developing a significant complication, beyond spontaneous preterm birth, so they can be triaged to enhanced management and further assessment.
Development Status: Discovery and verification work are complete, as well as a robust initial market assessment of physicians, patients, and payers.
Preeclampsia
Condition: Preeclampsia, estimated to affect 5% - 8% of pregnancies in the United States, is a complication characterized by high blood pressure and signs of damage to one or more organs, including liver, brain and kidneys, and may also have adverse effects on blood coagulation. Preeclampsia usually begins after 20 weeks of pregnancy in women whose blood pressure had been normal, but it can also arise earlier in pregnancies. Left untreated, preeclampsia can lead to serious, even fatal, complications for both the mother and baby. Once a pregnant woman is diagnosed with preeclampsia, a common treatment is to deliver the baby; however, if the delivery occurs before the infant reaches term (preterm preeclampsia), complications of preterm birth can ensue, and clinical decisions are challenged by weighing the risk to the mother of continuing the pregnancy versus the risks to the baby associated with early delivery.
Objective for a Biomarker Test: The company is working to develop a protein biomarker test that can identify women at higher risk of developing preterm preeclampsia to enable earlier proactive interventions to mitigate the complications that occur as a result of this condition.
Development Status: The company has completed discovery, verification and validation using its proprietary biobanks of several preterm preeclampsia biomarker predictors, some of which has been published. Some of these predictions include the use of the company’s PreTRM test biomarkers, as well as others. The company is in the process of selecting the final predictor and the optimal commercialization strategy.
Other Potential Products
Growth Restriction
Condition: Fetal growth restriction, or FGR, is estimated to affect as many as approximately 3%-7% of pregnancies worldwide. There are immediate consequences of FGR, including fetal challenges in withstanding the stresses of vaginal delivery, decreased oxygen levels and brain injury, hypoglycemia (low blood sugar), lower resistance to infection, difficulty in maintaining body temperature and abnormally high red blood cell counts. In the longer term, infants can have neurodevelopment issues, metabolic and cardiovascular complications.
Objective for a Biomarker Test for FGR. By identifying molecular events that precede measurable changes in fetal size, the company intends to address the placental dysfunction and other growth restriction etiologies that lead to fetal growth restriction and thereby enable earlier proactive interventions.
Development Status: The company has discovered placental dysfunction biomarkers as a first step to predicting fetal growth restriction. The company is working to discover additional biomarkers that illustrate expression differences in normal and growth-restricted pregnancies.
Gestational Diabetes Mellitus
Condition: Gestational diabetes mellitus, or GDM, is characterized by high blood sugar levels, or hyperglycemia, during pregnancy in a woman who was not diabetic before her pregnancy.
Development Status: The company has discovered and verified high performing biomarker prediction of GDM by applying its proteomics platform technologies to specimens from its PAPR and TREETOP biobanks.
Stillbirth
Condition: Stillbirth is a heartbreaking and tragic outcome, with a reported incidence of 5.7 per 1,000 pregnancies in the United States. Stillbirth is typically defined as fetal loss occurring after 20 weeks’ gestation. Causes of stillbirth include placental or umbilical cord problems, preeclampsia, lupus, clotting disorders, lifestyle choices, and infection, among others. Approximately one-third of U.S. stillbirth cases occur without any known cause.
Development Status: The company has developed the ability to measure the expression of hundreds of proteins by its advanced mass spectrometry proteomic technology. These proteins are members of key biochemical proteomic pregnancy signaling pathways, including pathways that are operative in stillbirth. Finally, the company notes that development for prediction of other adverse outcomes (e.g., growth restriction) has the potential to reduce stillbirth.
Postpartum Depression
Condition: There are hormonal, physiological and psychological changes that occur in women both during and after pregnancy. Postpartum depression is a severe form of clinical depression related to pregnancy and childbirth, affecting approximately 15% of women during the year following delivery of a child. By contrast, the ‘baby blues’ is a transient, well-known phenomenon that typically resolves on its own.
Development Status: In the company’s discovery efforts, it has discovered protein expression patterns in hormone signaling pathways and other pathways of pregnancy. The company is working to increase the coverage of biochemical signaling pathways and expression patterns related to postpartum depression in its protein expression database.
Commercialization
Given the substantial economic benefits demonstrated using the PreTRM test, the company is pursuing reimbursement for the PreTRM test by integrated systems, institutional physician networks, self-insured employers, and major health insurance payers.
With the publication of results from the AVERT trial and anticipated publication of results from the PRIME study, the company has entered a new phase of commercialization focused on driving clinician awareness, seeking early reimbursement, creating supporting evidence for guideline inclusion, accelerating PreTRM test adoption in the United States, and exploring international expansion.
The company has launched efforts to broaden its PreTRM investigator and key opinion leader network with the Investigator-Initiated Research Program at the SMFM meeting in January 2025. This program will support investigators interested in researching the use of the PreTRM test and novel interventions to reduce health complications of preterm birth.
The company will seek to publish the efficacy of the PreTRM test-and-treat strategy from its recently completed PRIME study and to continue real-world evidence studies to understand the impact of the PreTRM test in reducing health disparities.
The company is also evaluating the expansion of its business internationally, with an initial focus on Europe. The company is actively preparing test manufacturing capabilities through partnerships with companies in Europe and are working with opinion leaders and regulators to potentially bring the PreTRM test-and-treat solution to these markets.
Material Agreements
Elevance Health Commercial Collaboration Agreement
In February 2021, the company entered into a commercial collaboration agreement with Elevance Health, or the Commercial Collaboration Agreement, relating to the commercialization of the PreTRM test.
Under this agreement, the company agreed to provide PreTRM tests to eligible individuals enrolled in, or serviced or covered by, the health insurance products of Elevance Health. The company also agreed to develop a sales, marketing, and customer service program, and to provide training and marketing to duly licensed physicians specializing in obstetrics and gynecology or family medicine, or licensed nurse midwives, at the reasonable request of Elevance Health.
Elevance Health Laboratory Services Agreement
Effective in November 2020, the company entered into a laboratory services agreement with Elevance Health, or the Laboratory Services Agreement, relating to its provision of PreTRM tests and related services during the PRIME study.
Under this agreement, the company provided clinical laboratory services as requested by participating physicians and other health care professionals, and written reports to those physicians and professionals of the results of the services performed in accordance with the PRIME study.
Intellectual Property
“Sera,” “PreTRM,” “The Pregnancy Company” and the company’s logo are its trademarks.
As of December 31, 2024, the company’s intellectual property portfolio included four issued U.S. patents, eight pending U.S. non-provisional patent applications, one international patent application under the Patent Cooperation Treaty (PCT), twenty-three granted foreign patents in Canada, Poland, Switzerland, China, France, Germany, Italy, Ireland, Japan, Spain, Russia, Australia, Israel, the United Kingdom, and seventeen member states of the European Union through a European patent with unitary effect, thirty-five pending foreign patent applications, and two U.S. provisional applications. The company’s owned patents and patent applications, if issued, are expected to expire between 2034 and 2045, in each case without considering any possible patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
Within the company’s intellectual property portfolio, it owns three patent families that relate to the company’s PreTRM test. The patent applications of the first patent family include composition claims directed to panels of biomarkers and corresponding method claims for determining probability for preterm birth, gestational age at birth or time to birth in a pregnant female. The first patent family includes a pending U.S. patent application, nine foreign patents granted in Australia, France, Germany, Italy, Ireland, Spain, Canada, Japan, and the United Kingdom; and five pending foreign patent applications in the EPO, China, Australia, Japan, and Canada. The granted patents and pending patent applications, if issued, are expected to expire in 2034, without taking into account maintenance, renewal, annuity, or other governmental fees. The patent applications of the second patent family include composition claims directed to compositions of biomarkers, panels of biomarkers, and corresponding method claims for determining probability for preterm birth in a pregnant female and discloses methods for determining probability of gestational diabetes. The second patent family includes three issued U.S. patents, twelve foreign patents granted in Japan, Russia, Australia, China, Israel, Ireland, Poland, Spain, Switzerland, the United Kingdom, and seventeen member states of the European Union through a European patent with unitary effect, one pending U.S. patent application and ten pending foreign patent applications in the EPO, Canada, Australia, Japan, Hong Kong, Brazil, and China. The granted patents and pending patent applications, if issued, are expected to expire in 2036, without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. The patent applications of the third patent family include claims directed to antibodies and methods of using such antibodies for binding to specific biomarkers. The third patent family includes one pending U.S. application and six pending foreign patent applications in the EPO, Canada, Japan, Australia, Korea, and Brazil. The pending patent applications, if issued, are expected to expire in 2043, without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
The company also owns granted patents and pending patent applications directed to other indications. One patent family relates to determining probability for preeclampsia in a pregnant female, and includes two granted patents in Australia and Canada, and five patent applications pending in the U.S., the EPO, Australia, Hong Kong, and Canada. The granted patent and pending patent applications, if issued, are expected to expire in 2034, without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. Similarly, another related patent family is directed to biomarker panels and methods for predicting preeclampsia in a pregnant female. This includes four patent applications pending in the U.S., the EPO, Canada, and Japan. The pending patent applications, if issued, are expected to expire in 2042, without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. A third patent family relates to determining probability for preterm birth associated with preterm premature rupture of membranes in a pregnant female. It includes one pending U.S. patent application and three patent applications pending in Japan, Australia, and Israel. The pending patent applications, if issued, are expected to expire in 2037, without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. A fourth patent family relates to determining the estimated due date for a pregnant female, and includes one granted patent in the U.S. and four patent applications pending in the U.S., the EPO, Canada, and Australia. The pending patent applications, if issued, are expected to expire in 2038, without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees. A fifth patent family relates to pairs of biomarkers, compositions, and methods for predicting the probability for preterm birth in a pregnant female. It includes two pending applications in the U.S. and Canada. Any patent applications from this patent family, if issued, are expected to expire in 2042, without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity, or other governmental fees.
Government Regulation
As a clinical laboratory, the company is required to be certified under Clinical Laboratory Improvement Amendments (CLIA) to conduct its business. The company’s clinical laboratory facility located in Salt Lake City; Utah holds a CLIA Certificate of Accreditation.
The company is also accredited by the College of American Pathologists, (CAP). CMS has deemed CAP standards to be equal to or more stringent than CLIA regulations, and CAP is authorized to inspect the laboratories that it accredits on CMS’ behalf.
In addition, as a condition of CLIA certification, the company’s laboratory is subject to survey and inspection every other year, as well as random inspections. These biannual surveys are typically conducted by CAP because it holds a CLIA Certificate of Accreditation.
The company’s advertising for laboratory services and tests - as well as for nonmedical products, such as its LikeMine webapp - is subject to federal truth-in-advertising laws enforced by the Federal Trade Commission, or FTC, as well as similarly broad state laws.
As a clinical laboratory, the company is acting as a Covered Entity and is subject to the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the federal Health Information Technology for Economic and Clinical Health Act, or HITECH, and the regulations promulgated thereunder.
Although it appears that the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) was intended to reach patient brokering and similar arrangements in the context of substance use recovery and treatment, EKRA’s language is broad.
History
Sera Prognostics, Inc. was founded in 2008. The company was incorporated in the state of Delaware in 2008.
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